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Territory: Boca Raton, FL - Psychiatry Target city for territory is Boca Raton - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Boca Raton, Pompano, Coral Springs, Parkland and Delray Beach. SUMMARY: Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept at executing against the toughest commercialization challenges in today’s rapidly changing environment and must demonstrate strong capability in the following areas: ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use digital tools and apply data-based insights to create opportunities, develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Customer Development - Build and maintain productive internal and external relationships based on customer needs and organizational goals, incorporating “total office” account management. Local Market & Therapeutic Area Expertise - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Reimbursement - Consistently demonstrate the ability to stay informed on reimbursement dynamics, anticipate and effectively address payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. REQUIRED EDUCATION, EXPERIENCE and SKILLS: • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university., • 2+ years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience., • Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually., • Self-starter, with a strong work ethic and outstanding communication skills., • Must be computer literate with proficiency in Microsoft Office software., • Must live within 40 miles of territory boundaries., • Driving is an essential duty of this job; must have a valid driver’s license in good standing., • Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • Previous experience within a specialty product sales force., • Prior experience promoting and detailing products specific to CNS/neuroscience including: depression, schizophrenia and bipolar disorder., • Documented successful sales performance., • Ownership and accountability for the development and execution of fully integrated account plans., • Strong analytical background, and experience using sales data reporting tools to identify trends., • Experience in product launches., • Previous experience working with alliance partners (i.e., co-promotions)., • Strong leadership through participation in committees, job rotations, panels and related activities. TRAVEL: • Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $120,000 - $140,000 and eligibility for a sales incentive target of $40,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our _. Applications accepted on an ongoing basis. Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the _. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the _. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in _.

JOB TITLE Quality Operation Engineer II DEPARTMENT Quality Engineering JOB CODES Exempt MAIN PURPOSE OF JOB AND OBJECTIVES Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Responsible for supporting the quality engineering operations of receiving inspection, in-process and finished product and maintaining processes and methods in accordance with the company standards. Reporting on the performance of the assigned quality areas. Responsible to maintain regulatory compliance. Develops quality standards and controls. Develops product and process qualifications/validation protocols/reports for new products and existing manufacturing production lines. Advises company management on quality assurance requirements. Review non-conforming product along with product risk assessment and perform product failure investigations. Drives Supplier and Production Quality improvements, including efficiency and productivity improvements while maintaining compliance. POSITION IN ORGANISATION Position in organization can be found on the Organizational Chart via the company intranet. KEY DUTIES • Participates in the nonconformance process to ensure timely completion of documentation stages, • Identifies, Reports and Monitors Nonconforming events for the areas of responsibility, • Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence, • Interacts with cross-functional teams to resolve quality issues, • Quality control, product release authorizations, and quarantine of all suspect or discrepant product., • Develops Quality Instructions and Quality Standards., • Support in the development, validation and implementation of Test Methods., • Suggests, implements, reviews and approves engineering changes to support product life cycle., • Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc., • Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities., • Applies knowledge in Quality Systems to execute overall project assignments, • Applies statistical tools to analyze data and identify root cause and problem resolution, • Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations, • Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives., • Ensures quality system compliance for areas of responsibility., • Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention, • Perform and lead risk assessment exercises in support of validation activities Additionally, this role may also have some or all the following responsibilities (based on specific role within the organization): • Drive Quality Systems improvement and implementation projects, • Oversees the Nonconformance process to ensure timely completion of documentation stages and drives monthly meetings, • Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ), • Drive supplier quality activities as directed per line manager DIMENSIONS & LIMITS OF AUTHORITY COMPANY REQUIREMENTS • Must work within requirements of company handbook and policy statements Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system QUALITY REQUIREMENTS • Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives, • Always Work within the QMS, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality, • Responsible to ensure facility, processes and documentation always remain in a state of audit readiness EH&S REQUIREMENTS • Take care of your own health and safety and that of others who may be affected by your actions, • Work co-operatively to highlight issues affecting Environmental Health and Safety QUALIFICATIONS & EXPERIENCE Minimum Skills & Capabilities: • Works with all levels within the company., • Ability to organize and conduct multiple, parallel tasks, • Excellent Written and Verbal Communication, • Understanding of quality system regulations (ISO13485, 21CFR820), • Ability to interact with all levels within organization, • Analytical skills for compiling and analyzing data, • Mechanically inclined, • Knowledge of DOE, SPC, Gage R&R, and sampling plans, • Computer and software skills, • Ability to motivate others and improve efficiency, • Six Sigma Certification a plus, • ASQ Quality Engineer Certification a plus, • Statistics and data analysis Minimum Knowledge & Experience required for the position: • Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical engineering), or equivalent, with a minimum of 8 years of experience in medical device quality assurance., • Minimum 3 years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience, • Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971)., • Understanding of required standards / regulations impacting Medical Devices., • Leadership ability and organizational skills., • Strong team-oriented professional with good interpersonal skills who is hands-on with a high energy approach to work., • Must have experience handling nonconforming events, • SAP knowledge is a plus

🌿 Now Hiring: Psychedelic Facilitator Segal Trials | Center of Psychedelic & Cannabis Research Segal Trials is one of the few private research sites in the U.S. selected to conduct FDA-regulated clinical trials involving psychedelic compounds for mental health conditions. Recognized as a gold-standard research center, we are advancing the future of evidence-based psychedelic care through rigorous science, ethical practice, and compassionate participant support. We are seeking an experienced Lead Psychedelic Facilitator to provide clinical and operational leadership across psychedelic and cannabis research trials. This role uniquely blends therapeutic presence, research rigor, and program development within a highly regulated clinical research environment. What You’ll Do • Facilitate preparatory, dosing, and post-dosing integration sessions in alignment with study protocols, • Ensure participant safety, data integrity, and adherence to GCP/GDP standards, • Provide oversight of facilitator staffing, training, mock sessions, and ongoing performance evaluation, • Work closely with investigators, study coordinators, raters, regulatory teams, and sponsors, • Support program growth, sponsor engagement, recruitment efforts, and select public-facing initiatives Who You Are • Psychiatric NP or PA, • Highly experienced in working with altered states of consciousness, including preparation and integration, • Prior psychiatric clinical research experience preferred, • Psychedelic dosing session experience strongly desired ✨ This is a rare opportunity to help shape the future of psychedelic medicine within an elite, science-driven research organization at the forefront of clinical innovation. 👉 Apply or message us to learn more.

Fort Lauderdale, FL (On-Site) $140,000 – $180,000 Base Salary Full-Time | Monday–Friday A fast-growing healthcare and pharmaceutical organization is seeking an experienced Human Resources Director to lead and scale the HR function across a highly regulated operational environment. This company specializes in compounding pharmacy and healthcare services, supporting clinical, operational, and quality-driven teams in a fast-paced setting. The ideal candidate is a strategic HR leader who can operate both at the executive level and in day-to-day HR operations. This role will partner closely with leadership to drive workforce planning, talent acquisition, employee engagement, compliance, and organizational development initiatives. What You’ll Be Doing: • Lead and execute HR strategy aligned with company growth and operational goals, • Oversee talent acquisition for pharmacists, pharmacy technicians, sterile compounding teams, and corporate staff, • Drive employee relations, performance management, and leadership development initiatives, • Ensure compliance with employment laws, HR policies, and regulatory standards, • Partner with executive leadership on workforce planning and organizational design, • Manage compensation structures, benefits administration, HR operations, and vendor relationships, • Lead and mentor the HR team across recruiting, benefits, and HR management functions, • Champion culture, engagement, retention, and internal communication strategies Required Qualifications: • 8+ years of progressive HR leadership experience, • Background in healthcare, pharmacy, biotech, or another highly regulated industry, • Strong knowledge of employment law, compliance, and HR best practices, • Experience supporting licensed professionals and operational teams, • Proven ability to build HR infrastructure in a growing organization, • Strong communication, leadership, and stakeholder management skills, • Bachelor’s degree in Human Resources, Business Administration, or related field Preferred / Nice to Have: • Master’s degree, • Experience within sterile compounding or pharmacy environments, • PHR, SPHR, SHRM-CP, or SHRM-SCP certifications, • Familiarity with FDA guidance, USP standards, and pharmacy board regulations Why This Role: • Executive-level visibility and partnership with leadership, • Opportunity to shape HR strategy within a rapidly scaling organization, • High-impact role with influence across operations, quality, and culture, • Strong compensation package and long-term growth potential If you have experience leading HR functions in regulated environments and enjoy building scalable people operations, this could be an excellent opportunity to make a meaningful impact.

ZEO ScientifiX is looking for a Quality Control Associate ZEO ScientifiX is a clinical stage biotechnology company developing cell and extracellular vesicle-based therapeutics. ZEO ScientifiX is seeking a Quality Control Associate to perform technical and quality procedures within our Quality Management Program for the manufacturing and drug development laboratory. Responsibilities of the Quality Control Associate include a variety of technical activities involved with biologic drug manufacturing and quality assurance/control operations. South Florida local applicants are encouraged to apply Responsibilities: • Manage quality control activities involved with biologic drug manufacturing and facility quality control operations., • In general, oversee and review facility operation practices, complete and review product testing procedures, maintenance of laboratory SOPs, participate in process validations, and complete equipment management., • Work jointly with the lab team to ensure facility compliance and maintain operational standards for cell and biologic manufacturing., • Ensures compliance with regulatory standards (e.g., FDA, EMA, CLIA, GLP, GMP), • Coordinate lab training and competency tracking, • Reviews validation and qualification documentation (equipment, methods, systems), • Ensures data integrity and adherence to Good Documentation Practices (GDP), • Perform environmental monitoring Qualifications: · Must have prior experience in a biomedical / tissue manufacturing quality systems operation · B.S. or M.S. in Biomedical Sciences or related sciences are encouraged to apply Must be highly motivated with professional etiquette Must be a skilled writer Must demonstrate self-initiative Have excellent organizational skills Have strong attention to detail Strong communication skills with internal and external individuals Must be comfortable working with computers and digital communication Job Type: Full Time Education: Bachelor of Science (BS) degree or Higher (required) Benefits: 401K Program Health Insurance, Dental, Vision

Job description: Job Summary: The Validation Engineer will be responsible for executing and supporting validation activities within a pharmaceutical manufacturing environment. This is a hands-on, shop-floor–focused role requiring direct involvement with equipment, processes, and systems to ensure compliance with regulatory standards and operational excellence. The ideal candidate will have strong experience in injectable manufacturing and a practical approach to validation execution. • Salary range: $70,000 – $80,000 per year Key Responsibilities: • Execute validation activities including IQ, OQ, PQ for equipment, utilities, and processes., • Perform hands-on validation work on the shop floor, ensuring protocols are followed and documented accurately., • Prepare, review, and execute validation protocols and reports., • Support process validation, cleaning validation, and equipment qualification activities., • Work closely with manufacturing, engineering, and quality teams to ensure smooth validation execution., • Troubleshoot validation issues in real time and implement corrective actions., • Ensure compliance with cGMP, FDA, and regulatory requirements., • Assist in risk assessments and impact evaluations related to validation activities., • Support change control, deviations, CAPA, and revalidation activities., • Maintain validation documentation in accordance with company and regulatory standards. Requirements: • Bachelor’s degree in Engineering, Pharmacy, or a related field., • Minimum of 8+ years of validation experience in the pharmaceutical industry., • Mandatory experience in injectable manufacturing., • Hands-on experience with equipment qualification and process validation., • Solid understanding of cGMP, FDA regulations, and validation lifecycle., • Strong problem-solving and troubleshooting skills. Apply now!

Job Description Position Summary We are seeking a detail-oriented QA Inspector to join our team on the night shift. This role is responsible for performing in-process inspections, ensuring compliance with cGMP standards, and maintaining accurate documentation in accordance with internal procedures and regulatory requirements. Schedule: Monday – Friday | 9:30 PM – 5:15 AM Pay Rate: $20.37 –$22 per hour Essential Functions & Responsibilities • Perform inspection of in-process and finished products, ensuring proper documentation., • Ensure compliance with cGMP regulations at all times on the production floor., • Conduct QA tasks including sampling, inspections, and testing to verify compliance with: Internal SOPs, Company policies, Safety initiatives, FDA and DEA regulations, • Inspect and approve rooms, production lines, and equipment prior to use., • Approve components for in-process operations., • Monitor manufacturing and packaging areas for compliance with SOPs and regulatory standards., • Document all work in batch records, logs, and forms accurately and thoroughly., • Sample in-process materials and finished products; distribute samples as required., • Review documentation for accuracy and compliance with cGMP and Good Documentation Practices., • Inform management of deviations, problems, or failures., • Apply disposition status to components and in-process materials., • Issue QA Alerts when questionable materials or products are identified., • Perform other duties as assigned by the supervisor. Qualifications • Associate degree or equivalent work experience., • 1–3 years of experience in Quality Control within a manufacturing environment., • Bilingual (English/Spanish) required., • Knowledge of cGMP regulations and FDA guidelines., • Detail-oriented with strong documentation skills., • Basic computer and math skills.

Job Description At Precision Medicine, we are revolutionizing healthcare! Our mission is to empower the evolution of modern medicine by providing accessible, personalized, and efficient healthcare solutions. Join our dynamic team where your voice matters, your ideas are valued, and your unique background enriches our culture. We celebrate diverse perspectives and foster an environment where you can thrive, innovate, and make a meaningful impact on patients' lives. Job Summary The PV2 Pharmacist plays a critical role in ensuring accurate, timely, and regulatory-compliant verification of prescriptions processed during the shift. This position focuses on the second stage of prescription verification (PV2), providing a final review before fulfillment and shipment to patients. Essential Functions and Responsibilities • Prescription Verification: perform PV2 verification of prescriptions to ensure accuracy, safety, and compliance with legal requirements, • Regulatory Compliance: Adhere to all federal, state, and local regulations, including DEA and FDA guidelines, while maintaining accurate records, • Quality Assurance: Identify and resolve discrepancies or issues in prescriptions to ensure medication safety and accuracy before fulfillment, • Collaboration: Work closely with pharmacy technicians, PV1 pharmacists, and fulfillment staff to ensure smooth operations during the shift, • Metrics Tracking: Monitor and maintain productivity metrics to align with pharmacy goals and efficiency benchmarks, • Operational Support: Assist in troubleshooting any issues related to prescription processing, verification systems, or workflow interruptions during the midnight shift, • Communication: Provide end-of-shift updates to the incoming team to ensure seamless transitions and continuity of operations Qualifications Requirements: • Degree in Pharmacy from an accredited institution, • Active Florida pharmacist license, • Prior experience in a compounding pharmacy, • Strong understanding of medication administration and pharmacology principles, • Ability to work effectively in a fast-paced environment, • Excellent communication skills and ability to work collaboratively with a multidisciplinary team Job Type: Full-Time Work Location: In person Salary: $50-$60 per hour Schedule: • 9:00 am – 5:00 pm, • Monday - Friday Ability to Commute: • Boca Raton, FL (Required) Why Join Us As part of Precision Medicine, you'll be at the heart of an exciting transformation in the telemedicine landscape. Together, we're pioneering solutions that bridge technology and compassionate care, improving health outcomes for all. We're committed to your growth, providing you with the resources and support you need to build a meaningful career while exploring your creativity. Ready to be a part of something groundbreaking? Join us as we move healthcare forward, one innovation at a time! Learn more at: https://mypcphealth.com/ Equal Opportunity Statement Precision Medicine is committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace, and throughout the markets we serve. The EEO posters are available here. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at recruiting@mypcphealth.com to request accommodation.

Job Description We are seeking a detail-oriented and proactive Formulator Assistant to join our Product Development team. This role is ideal for someone with a background in Chemistry, Biology, Food Science, or a related field, and at least one year of experience in a regulated industry such as nutraceuticals, pharmaceuticals, or food. Qualifications: • Bachelor’s degree in Chemistry, Biology, Food Science, or related field., • At least 1 year of experience in a laboratory, formulation, R&D, or regulatory role within an FDA-regulated industry (nutraceutical, pharmaceutical, food, medical devices, personal care, etc.)., • Ability to perform basic calculations (percentages, concentrations, unit conversions, pricing)., • Bilingual (English and Spanish) Essential Functions: • Draft formulations for quotes, lab batches, pilots, and testing during product development., • Troubleshoot formulations based on lab, pilot, testing outcomes, and pricing adjustments., • Conduct basic physical and organoleptic testing (e.g., weighing, particle size measurement)., • Review regulatory documentation to ensure compliance in formulation., • Log and track new raw materials for assigned projects., • Maintain accurate formulation records and track development progress., • Write change controls and deviation documents related to formulations., • Communicate project updates to the R&D Manager regularly., • Participate in meetings with clients, suppliers, and cross-functional teams as needed.

Job Description The Quality Assurance Manager will lead all aspects of the quality function, ensuring operations consistently meet regulatory expectations, including compliance with 21 CFR Part 111. This position plays a critical role in shaping quality systems, maintaining documentation integrity, supporting audits, and partnering cross-functionally to uphold product quality and safety standards. The role also drives continuous improvement initiatives and fosters a strong culture of compliance throughout the organization. Key Duties and Responsibilities • Supervise and develop Quality team members through coaching, performance feedback, and structured training in GMP principles and internal procedures., • Establish, implement, and monitor SOPs to ensure ongoing compliance with 21 CFR Part 111 and related regulatory standards., • Plan and manage inspections and audits conducted by regulatory agencies and third parties, including preparation activities and resolution of any observations., • Oversee company-wide training compliance by managing onboarding programs, GMP education, SOP instruction, and qualification tracking., • Maintain oversight of document control processes, including the creation, revision, and accuracy of Master Manufacturing Records (MMRs) and Batch Production Records (BPRs)., • Lead investigations into quality events such as deviations, nonconformances, and Out-of-Specification (OOS) results, ensuring effective root cause analysis and CAPA implementation., • Direct supplier quality management activities, including vendor approval, ongoing performance evaluation, and raw material risk assessments., • Verify that product formulations, specifications, and labeling meet all applicable regulatory and customer requirements prior to release., • Govern change control procedures to evaluate and document the impact of changes on product quality and compliance., • Act as the primary liaison for customer-related quality matters, including agreements, documentation requests, and technical communications., • Manage the review and response process for customer complaints, including trend monitoring and corrective action implementation., • Maintain a state of readiness for inspections by ensuring alignment with dietary supplement cGMP requirements at all times., • Collaborate with production and packaging teams to ensure processes consistently meet defined quality and safety standards., • Execute internal audit programs to assess adherence to regulatory expectations and internal policies., • Track, analyze, and interpret quality data to identify trends, mitigate risks, and support continuous improvement initiatives. Required Qualifications • Bachelor's degree in a scientific or technical discipline such as Food Science, Chemistry, Biology, or Quality Systems., • At least 5 years of experience in quality assurance within dietary supplements, food manufacturing, or pharmaceutical environments., • In-depth knowledge of 21 CFR Part 111, cGMP regulations, FDA requirements, and quality management systems., • Hands-on experience with audit management, CAPA processes, supplier quality programs, and regulatory inspections., • Experience working with electronic document control systems and quality management software Compensation: $110,000 to $120,000 plus commission and full benefits If this sounds like the position you have been waiting for, please apply using the online application or the link below - all inquiries are strictly confidential. Our focus is to assist you to make your best next career move, and we will not use your information for any other purpose. Kalon Executive Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. www.kalonsearch.com

Job Description A well-established pharmaceutical company in Miramar, FL is seeking an experienced and detail-oriented Quality Assurance (QA) Document Control Specialist to support its evening shift operations. This role is responsible for maintaining, reviewing, and managing GMP documentation to ensure compliance with regulatory standards. The ideal candidate is bilingual (English/Spanish), organized, and has prior experience in pharmaceutical or FDA-regulated environments. Location: Miramar, FL Industry: Pharmaceutical Manufacturing Job Type: Full-Time Schedule: Monday to Friday, 2:30 PM – 11:00 PM Pay: $19.00 per hour Key Responsibilities Maintain and control quality documentation in accordance with GMP and FDA guidelines Review and archive manufacturing, packaging, and testing records for accuracy and completeness Ensure proper version control and distribution of controlled documents (SOPs, batch records, etc.) Assist in audits, inspections, and internal reviews by preparing and providing requested documentation Support QA team in implementing document changes, updates, and approvals Ensure timely and accurate entry of documentation into digital or physical filing systems Collaborate with production, quality, and regulatory departments to ensure documentation compliance Report any deviations or non-conformances found in records Qualifications Minimum 1–2 years of experience in document control or QA in a pharmaceutical or FDA-regulated environment High school diploma or equivalent required; associate or bachelor's degree preferred Strong knowledge of GMP, SOPs, and document control best practices Excellent attention to detail and organizational skills Bilingual (English/Spanish) – required Proficient in Microsoft Office (Excel, Word, Outlook) Ability to work independently with minimal supervision during evening shift hours

Job Description If you’re reading this on your way from 5am spin class to festival fast-pass, you’re CELSIUS®— an everyday hustler with the essential energy to aim high, and go the extra mile wherever your goals take you. Joyful by design, sunny by nature, and unapologetically bold. If your bestie has you saved in their phone as “Icon,” you’re ALANI NU® — confident, colorful, and bringing main-character energy to every moment. SoCal in your soul, attitude in your stride. If gravity doesn’t stop you and “impossible” sounds more like “dare you,” you’re ROCKSTAR®— a born rebel, raising the bar with mind-body energy and zero compromise. --- Together, we’re Celsius Holdings, Inc.— a global CPG company united by three powerhouse brands and one incredibly talented team. At Celsius, we pride ourselves on empowering our people. Every employee has a stake in our success. We create a collaborative culture built on inclusivity, innovation, and a belief that great ideas can come from anywhere. And we’re on our way to building something bigger: a category where energy isn’t just consumed, it’s lived—where performance meets personality, brand becomes community, and every can crack sparks a statement. This is the future of modern energy. This is Celsius. Ready to take your career to the next level? Join our team and redefine what it means to be energized. People Management Responsibilities: No Role Type: Full-Time Location: Boca Raton, FL Position Overview As the Regulatory Analyst, you’ll be a key member of the Legal department, partnering cross-functionally with marketing and innovation teams to ensure products and brand communications meet global regulatory standards. This is your opportunity to apply your expertise in CPG compliance—ideally in the beverage or energy drink category—to a fast-paced, industry-leading organization that thrives on innovation and performance. You’ll bring a sharp attention to detail, a collaborative mindset, and a proactive approach to regulatory review processes that support product launches, campaigns, and packaging initiatives. Requirements • Experience: 3+ years in regulatory compliance within the consumer packaged goods (CPG) industry, beverage or energy drink category strongly preferred, • Education: Bachelor’s degree in Regulatory Affairs, Food Science, Law, or related field, • Knowledge of FDA, FTC, and other regulatory requirements for food and beverage products, with experience in dietary supplements a plus., • Familiarity with substantiation standards for claims and marketing copy, • Strong communication and stakeholder engagement skills, • Experience reviewing product packaging, digital content, and advertising assets, • Proficiency in regulatory documentation, labeling laws, and claim substantiation, • Ability to translate complex regulatory standards into practical guidance for cross-functional teams Responsibilities • Review marketing materials, packaging, social media, and digital content for regulatory compliance, • Advise marketing, innovation, and R&D teams on claim substantiation and labeling requirements, • Partner with legal and regulatory colleagues to monitor changing laws and guidance in key markets, • Support the development of compliant communication strategies for product launches and rebrands, • Conduct regulatory risk assessments on new campaigns and product innovations and identify product formulation risks, • Maintain organized documentation and audit trails of approvals and regulatory decisions, • Collaborate with internal teams and external counsel to resolve regulatory inquiries and challenges Benefits • Comprehensive Medical, Dental & Vision benefits, • Long- and short-term disability, • Life insurance, • 10 Vacation days per year, subject to accrual policy, • 11 Company paid holidays, • 401(k) with Company match, • Identity theft and legal services The base salary range for this position is dependent on experience and location. The final offer will be determined based on job-related knowledge, skills, and qualifications. This position may be eligible for other compensation, including bonuses and Restricted Stock Units (subject to company plans). We promptly review all applications. Highly qualified candidates will be contacted for interviews. Colorado Applicants: Applications are accepted on an ongoing basis until the position is filled. CELSIUS Holdings, Inc. celebrates diversity and is committed to creating an inclusive environment for all employees. We provide equal employment opportunities (EEO) to all applicants without regard to race, ethnicity, religion, gender identity, sexual orientation, disability status, or any other characteristic protected by applicable laws. If you require accommodations during the application process, please reach out to careers@celsius.com. The above information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job

Job Description Quality Assurance Representative, Ft. Lauderdale, FL ($27-31/hr) Job Summary: This position is responsible for quality element control related to operation, policy and procedure auditing, supporting quality improvement projects, and supporting the manager to drive defect prevention and detections. The position acts as the primary business unit liaison to US Quality Assurance. Responsibilities: • Coordinates and monitors quality improvement projects, • Audits implementation of quality system for effectiveness by verifying operation activities to Gate, Customer and Regulatory specification, • Monitors corrective action system, • Educates and trains u nit staff and managers in quality related issues, • Plays a key role in developing a comprehensive quality program, • Implements the quality system detailed in the quality manual, • Champions the total quality improvements efforts and initiates problem solving efforts and assures implementation, • Supports the Manager to drive prevention vs detection of defects, • Coordinates actions to present the occurrences of nonconformities, • Responsible for the maintenance of key performance metrics for the quality organization, • Acts as the primary liaison to the US Quality Assurance, • Controls food safety and quality of processing and manufacturing within the business, • Assists with developing SOP’sQualifications:, • 3+ years of experience in food safety control practices (GMP’s, SOP’s, and HACCP) and quality program control, • College degree in related discipline (preferred)., • Knowledge of HACCP, quality management and six sigma, • HACCP certified and ServeSafe trained (a plus), • Experienced with MS Word and Excel, • Basic statistic calculation and or mathematical comprehension including (Pareto chart, Control chart, Histogram, Time series (run chart), algebraic concepts, multiplication, division, etc), • Project Management skills, • Knowledge of FDA regulationsWork Environment: Regularly, stands, bends, lifts, and move during shifts of 10+ hours. Must be able to lift, push, pull and move product, equipment, supplies in excess of 25 lbs. Summit Federal Services, LLC is an equal opportunity employer regardless of race, color, religion, creed, sex, marital status, national origin, disability, age, veteran status, on-the-job injury, sexual orientation, political affiliation or belief. Employment decisions are made without consideration of these or any other factors that employers are prohibited by law from considering. Any discriminatory action can be a cause for disciplinary action. Summit Federal Services, LLC also prohibits discrimination against individuals with disabilities and will reasonably accommodate applicants with a disability, upon request, and will also ensure reasonable accommodation for employees with a disability. Powered by JazzHR WHmnLz8Xx4

Job Description Who we are: Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market. Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formulization, graphic design, manufacturing, packaging and delivery. Job Title: Quality Assurance Specialist – Supplier Quality Location: United States (On-site, CDMO Manufacturing Facility) Reports to: Quality Director Position Summary The Quality Assurance Specialist – Supplier Quality is responsible for managing all aspects of supplier quality and compliance within a cosmetics and topical over-the-counter (OTC) pharmaceutical contract development and manufacturing organization (CDMO). This role oversees supplier qualification, monitoring, and disqualification to ensure compliance with applicable regulatory standards, including FDA, ISO, and cGMP requirements. The position works cross-functionally with Procurement, Manufacturing, R&D, and Quality departments to ensure that all suppliers consistently meet quality, safety, and regulatory expectations. Key Responsibilities Supplier Quality Management Lead all aspects of supplier quality oversight, including onboarding, qualification, routine monitoring, and disqualification or exit. Evaluate and qualify suppliers across multiple categories: raw materials/ingredients, packaging components, printed materials, testing laboratories, and GMP service providers. Develop and maintain the Approved Supplier List (ASL) to ensure alignment across Procurement, R&D, and Operations. Perform supplier risk assessments and maintain supplier performance metrics and trend analyses for management review. Ensure supplier documentation and records comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Auditing & Compliance Plan and execute supplier audits (on-site and remote) to assess adherence to regulatory and internal quality standards (e.g., 21 CFR Part 211, ISO 9001, ISO 22716, ISO 17025). Manage audit schedules, reports, corrective and preventive actions (CAPAs), and Supplier Corrective Action Requests (SCARs). Review and approve supplier change notifications, assessing potential impact on product quality and regulatory compliance. Maintain supplier certifications and registrations (e.g., ISO, FDA, state-level registrations) and ensure timely renewals. Quality Systems Oversight Manage supplier-related quality agreements, quality risk assessments, monitoring reports, and change control activities. Support and lead supplier-related investigations and root cause analyses for deviations and nonconformances. Participate as a subject matter expert (SME) during internal audits, client audits, and health authority inspections. Ensure continuous improvement of supplier quality programs by analyzing performance data and driving process optimization initiatives. Cross-Functional Collaboration Partner with R&D, Manufacturing, Regulatory Affairs, Procurement, and Quality Control to ensure supplier capabilities align with product and regulatory requirements. Support the raw material approval program, ensuring appropriate testing, documentation, and qualification are in place prior to use. Regulatory Awareness & Continuous Improvement Stay informed on current regulatory trends, agency inspection findings (e.g., FDA Warning Letters), and evolving global standards affecting supplier quality management. Recommend and implement improvements to strengthen supplier oversight and ensure compliance with emerging industry best practices. Qualifications & Experience Experience: A High School Diploma or GED with 10 years’ experience or an associate or bachelor’s degree with 3–5 years of experience in Quality Assurance or Supplier Quality, ideally within a regulated cosmetics, OTC drug, personal care, food/supplement, or medical device environment. Regulatory Knowledge: Working knowledge of 21 CFR Parts 210/211, ISO 9001, ISO 22716 (Cosmetic GMPs), and ISO 17025 requirements. Technical Skills: Proficient in conducting supplier audits, risk assessments, CAPA management, and data-driven quality reporting. Experienced in AQL (Acceptable Quality Level) sampling inspection techniques; AQL certified preferred. Analytical Skills: Strong ability to identify compliance issues, perform root cause analysis, and implement effective corrective actions. Communication: Excellent verbal and written communication skills, with the ability to clearly convey technical and regulatory information to internal teams and suppliers. Soft Skills: Strong interpersonal and organizational skills; able to work independently, manage multiple priorities, and maintain confidentiality. System Experience: Familiarity with Quality Management Systems (QMS), document control systems, and supplier management databases preferred. Education Minimum: High School Diploma or GED Preferred: Associate’s or Bachelor’s degree in a scientific, engineering, or quality-related discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences, or Quality Management). Additional Information This position may require occasional domestic and international travel to perform supplier audits and assessments. Candidates should be comfortable working in a fast-paced, highly regulated CDMO environment supporting both cosmetics and OTC pharmaceutical clients. Equal Employment Opportunity Cosmetic Solutions is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

Job Description Position: Florida Licensed Pharmacist Location: Hybrid Pharma, Deerfield Beach, Florida Job Type: Contract / Per Diem / Temporary/ Full time Pay: Competitive hourly rate (based on experience) We are urgently seeking a Florida-licensed Pharmacist to assist with short-term and long term pharmacy operations. This is an ideal opportunity for professionals looking for flexible, immediate-start gig work in a fast-paced environment. We are looking specifically to fill immediate. Key Responsibilities: • Accurately verify and dispense prescription medications in accordance with Florida Board of Pharmacy regulations, • Provide clear, professional communication to patients and prescribers, • Oversee or assist with compounding [sterile and non sterile], • Ensure all processes comply with DEA, FDA, and state guidelines, • Maintain accurate documentation and uphold safety and quality standards, • Support daily operations, including workflow efficiency, inventory management, and regulatory compliance Requirements: • Active and unrestricted Florida Pharmacist License (Required), • Available to start immediately, • Strong knowledge of pharmacy operations, laws, and clinical best practices, • Previous experience in [retail, hospital, compounding – optional to tailor], • Excellent attention to detail, reliability, and communication skills To Apply: Please submit your resume, availability, and Florida license number. Qualified candidates will be contacted immediately. We are looking to fill this position ASAP We look forward to speaking to you! Job Types: Part-time, Contract, Temporary, Temp-to-hire, Per diem, Internship Benefits: • Flexible schedule, • Paid time off, • Professional development assistance Ability to Commute: Deerfield Beach, FL 33442 (Required) Ability to Relocate: Deerfield Beach, FL 33442: Relocate before starting work (Preferred) Work Location: In person Ready to revolutionize healthcare, making it faster and more accessible than ever before

Job Description Who we are: Cosmetic Solutions is a leader in the development and manufacturing of scientifically proven, innovative personal care products. With a focus on, face, body, hair, OTC, and professional use formulations, we create some of the most cost effective, high quality and powerful products on the market. Providing world class services to up and coming businesses, large established brands, physicians, estheticians and other skin care professionals; we specialize in research & development, custom formulization, graphic design, manufacturing, packaging and delivery. Job Title: Quality Assurance Specialist Company Overview: We are a leading manufacturing company dedicated to delivering high-quality products to our customers. Our commitment to excellence drives everything we do, and we are seeking a Quality Assurance Specialist to join our team and uphold our standards of quality and compliance. Position Overview: As a Quality Assurance Specialist, you will play a critical role in ensuring that our manufacturing processes meet regulatory requirements and adhere to our company's quality standards. You will be responsible for overseeing various aspects of quality assurance, including Good Manufacturing Practices (GMP), quality systems, Corrective and Preventive Actions (CAPAs), deviations, document control, and Standard Operating Procedures (SOPs). Key Responsibilities: • Good Manufacturing Practices (GMP):, • Ensure compliance with GMP regulations throughout the manufacturing process., • Conduct regular audits and inspections to verify adherence to GMP standards., • Develop and implement strategies to continuously improve GMP compliance., • Quality Systems Management:, • Maintain and improve the company's quality management system (QMS)., • Identify areas for process improvement and implement effective quality control measures., • Collaborate with cross-functional teams to ensure alignment with quality objectives., • Corrective and Preventive Actions (CAPAs):, • Lead investigations into quality issues and non-conformances., • Develop CAPA plans to address root causes and prevent recurrence of quality issues., • Monitor and track the implementation of CAPAs to ensure effectiveness., • Deviations Management:, • Investigate deviations from established procedures and specifications., • Document deviations and assess their impact on product quality., • Develop and implement corrective actions to address deviations and prevent recurrence., • Document Control:, • Establish and maintain document control procedures for quality documents., • Ensure the accuracy, completeness, and integrity of quality-related documentation., • Manage document change control processes and maintain document repositories., • Standard Operating Procedures (SOPs):, • Develop, review, and update SOPs to reflect current best practices and regulatory requirements., • Ensure SOPs are followed consistently throughout the organization., • Provide training and support to employees on SOPs and quality processes. Qualifications: • Bachelor's degree in a related field preferred (e.g., Quality Assurance, Chemistry, Biology, Engineering)., • Previous experience working in a manufacturing environment, preferably in a regulated industry (e.g., pharmaceuticals, medical devices, food)., • Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO)., • Experience with quality systems management, CAPAs, deviations, document control, and SOPs., • Excellent analytical and problem-solving skills., • Effective communication and collaboration abilities. Must be able to read, write, and speak in English. Bilingual preferred., • Detail-oriented with a commitment to quality and compliance. Join Our Team: If you are passionate about quality and have the skills and experience to excel in this role, we invite you to apply and join our dynamic team. Together, we will continue to uphold the highest standards of quality and excellence in everything we do. Cosmetic Solutions LLC. is committed to equal employment opportunity for all employees and applicants for employment without regard to age, color, creed, disability status, gender, national origin, race, religion, sexual orientation or veteran status, or any other legally protected status.

Job Description Position Overview We are seeking an experienced Sr. R&D Gummy Formulator to play a critical role within our Product Innovation and Manufacturing teams. This position is responsible for designing, improving, and scaling gummy-based formulations from early-stage development through commercial launch. The ideal candidate combines technical expertise in functional ingredient systems with strong cross-functional collaboration skills and a passion for creating high-quality, compliant products in a dynamic environment. This position is onsite in South Florida. Relocation assistance is available Primary Responsibilities Product & Formula Innovation • Design, evaluate, and refine gummy supplement formulations to meet quality, sensory, and regulatory requirements., • Execute bench-top and pilot-scale development work, including formula adjustments to improve consistency, stability, and manufacturability., • Perform shelf-life and stability assessments to verify product integrity over time., • Identify and assess ingredients such as active compounds, flavor systems, sweeteners, colors, and processing aids that align with product claims and clean-label objectives., • Optimize texture, flavor release, sweetness perception, and overall consumer experience. Regulatory & Quality Compliance • Ensure all products and processes comply with applicable regulatory standards, including FDA regulations, cGMP requirements, dietary supplement guidelines, and allergen management protocols., • Prepare and maintain technical documentation including raw material specifications, validation records, formulation data, and allergen tracking documentation., • Support regulatory activities related to product claims, supplement facts panels, and labeling accuracy., • Coordinate supplier approval activities and confirm ingredient quality, safety, and compliance standards. Process Improvement & Collaboration • Drive initiatives focused on production efficiency, cost reduction, product consistency, and sensory enhancement., • Partner closely with departments including Quality Assurance, Regulatory Affairs, Operations, and Commercial teams to support successful product launches., • Assist in troubleshooting manufacturing or formulation challenges during scale-up and production., • Contribute to maintaining audit-ready documentation and lifecycle records for products and batches., • Provide technical guidance and mentorship to junior team members while promoting safe and scientifically sound development practices. Required Qualifications • Bachelor's degree in Food Science, Chemistry, Biochemistry, Pharmaceutical Sciences, or another related scientific discipline; advanced education is a plus., • Minimum of 5 years of experience in Pectin Gummy formulation development within dietary supplements and nutraceuticals., • Demonstrated expertise specifically in gummy formulation and processing is essential., • Strong understanding of gummy systems including vegan applications, texture balancing, mouthfeel optimization, and sweetness modulation., • Working knowledge of FDA regulations, cGMP standards, 21 CFR Part 111 requirements, labeling compliance, ingredient safety evaluation, GRAS considerations, and allergen controls., • Experience evaluating raw materials, managing supplier relationships, and balancing formulation performance with cost considerations., • Familiarity with analytical and quality testing methods such as rheology, pH testing, texture analysis, stability protocols, and shelf-life evaluation., • Knowledge of sensory testing techniques and flavor profile development for consumer-friendly products., • Effective project management skills with the ability to manage multiple timelines and cross-department initiatives simultaneously. Compensation: $130,000-150,000 base plus benefits If this sounds like the position you have been waiting for, please apply using the online application or the link below. All inquiries are strictly confidential. Our focus is to assist you in making your best next career move, and we will not use your information for any other purpose. Kalon Search is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. www.KalonSearch.com

Job Description We are currently seeking a detail-oriented and motivated Regulatory Affairs Specialist. This role is crucial in ensuring that our products comply with all regulatory requirements. If you are passionate about regulatory affairs and looking for an opportunity to grow within a dynamic company, we encourage you to apply. Responsibilities: • Prepare, review, and submit regulatory documents to ensure compliance with FDA and other regulatory authorities., • Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to the pharmaceutical industry., • Assist in the preparation of regulatory submissions including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments., • Coordinate with cross-functional teams to gather necessary information for regulatory submissions., • Ensure timely and accurate communication with regulatory authorities., • Monitor and track the progress of submissions and respond to any inquiries from regulatory bodies., • Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management., • Maintain accurate and organized regulatory files and records. Requirements: • Bachelor’s degree in a related field such as biology, chemistry, or pharmaceutical sciences., • Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred., • Strong understanding of FDA regulations and guidelines., • Excellent organizational and time management skills., • Strong attention to detail and ability to handle multiple projects simultaneously., • Effective communication skills, both written and verbal., • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)., • Ability to work independently and as part of a team.

Job Description Who we are: Cosmetic Solutions is a leading manufacturer of cosmetic and OTC products, committed to innovation, quality, and continuous improvement. Our Quality Control team plays a vital role in ensuring our products meet the highest standards of safety, efficacy, and compliance. • We are seeking a detail-oriented and proactive Quality Control Technician to join our Raw Materials team. This role is essential to maintaining product integrity and regulatory compliance through rigorous testing and documentation practices., • Quality Control Lab Technician Major Responsibilities • Sample all incoming raw material for Quality control testing, • Conduct daily quality control testing, • Water, • Maintain the raw material standards library, • Conduct routine and non-routine testing of raw materials, in-process items, and finished goods., • Maintain retained sample inventory and storage area., • Calibrate and maintain lab equipment (pH meter, viscometer, balances)., • Review and follow SOPs, specifications, and related documentation., • Compile, interpret, and report analytical data., • Troubleshoot instruments and initiate investigations for anomalies and deviations., • Ensure compliance with GLP, GMP, and SOPs., • Document test results accurately in lab notebooks and databases., • Collaborate with cross-functional teams to resolve quality issues and implement corrective actions., • Participate in writing SOPs, OOS reports, deviations, CAPAs, and investigations., • Support sample testing, data entry, and coordination with external labs/vendors., • Promote and demonstrate company core values and participate in 6S lean initiatives., • Maintain a clean and organized lab environment., • Perform other duties as assigned by management., • Support the daily execution of the Quality Management System QUALIFICATIONS: • Written/oral communication skills required., • 2-3 years of experience in the Cosmetic or pharmaceutical industry preferred., • Associate’s degree or higher in Chemistry, Biology, or a related scientific discipline. Experience & Skills: • Experience in cosmetics, pharmaceuticals, or other FDA-regulated industries., • Strong knowledge of GLP, GMP, and regulatory standards., • Experience in a regulated laboratory environment., • Excellent attention to detail and organizational skills., • Strong problem-solving and analytical abilities., • Effective communication and teamwork skills., • Proficiency in Microsoft Office and laboratory data systems., • Ability to work independently and manage multiple priorities. Cosmetic Solutions LLC. is committed to equal employment opportunity for all employees and applicants for employment without regard to age, color, creed, disability status, gender, national origin, race, religion, sexual orientation or veteran status, or any other legally protected status.

Job DescriptionDescription: The Principal Scientist, QC Analytical serves as a senior scientific expert within the Quality Control organization, providing advanced technical leadership, method development oversight, and subject-matter expertise for analytical activities supporting raw materials, intermediates, drug substances, and final products. This role drives the development, qualification, and validation of complex analytical methods, supports technology transfer activities, and ensures analytical programs meet regulatory, corporate, and scientific standards. The Principal Scientist leads high-level investigations, provides technical mentorship across departments, and contributes to strategic initiatives supporting continuous improvement of QC Analytical operations. Requirements: • Provide expert leadership in analytical testing for biologics, vaccines, cell/gene therapies, or APIs, including techniques such as HPLC/UPLC, GC, CE, ELISA, compendial methods, spectroscopy, and bioassays., • Provide expert guidance for method lifecycle management, including phase-appropriate validation strategies and regulatory expectations., • Lead technical transfer of analytical methods from Process Development, Protein Characterization, and external partners into QC, ensuring successful integration into routine testing operations., • Act as primary scientific reviewer of QC analytical data, reports, protocols, and investigations to ensure accuracy, compliance, and scientific integrity., • Support the design, review, and execution of stability studies; develop stability-indicating methods and oversee evaluation of long-term and accelerated data., • Serve as the QC Analytical SME during audits, regulatory inspections, client meetings, and cross-functional technical discussions., • Provide advanced technical support for atypical results, including OOS, OOT, and ABT investigations; lead root cause analysis and propose scientifically sound corrective and preventive actions., • Contribute to continuous improvement initiatives, including new technologies, workflow optimization, data integrity enhancements, and analytical efficiency improvements., • Collaborate with QA, Manufacturing, Process Development, and Protein Characterization groups to resolve complex analytical issues and ensure alignment across teams., • Prepare and review scientific documentation including method development reports, validation protocols, stability reports, and analytical risk assessments., • Mentor and guide QC Analysts and Scientists, providing training in new methods, instrumentation, regulatory expectations, and scientific best practices., • Maintain deep knowledge of compendial, ICH, and FDA guidance and ensure analytical strategies align with current regulatory expectations. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. Education and Skills Required: • Ph.D. in biological sciences, biochemical sciences, analytical chemistry, or related field preferred or Master’s degree with extensive relevant experience may be considered., • Minimum of 8–10 years of experience in a GMP, FDA-regulated environment with a strong focus on analytical development, validation, and QC laboratory operations, • Proven track record of leading analytical teams and complex technical projects, • Expert-level knowledge of analytical methodologies such as HPLC/UPLC, CE, MS, ELISA, qPCR, and other characterization techniques., • Strong organizational, documentation, and time-management capabilities with high attention to detail.

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow, as one QuidelOrtho we are seeking a Scientist I to support our Immunohematology products. This person will be responsible for testing raw materials, in process bulk testing on Immunohematology products. This person will assure compliance with company standards and applicable regulatory agencies. You will be responsible to participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures. This is an onsite position located in Pompano Beach Florida. Work Schedule: 3rd-shift role with flexibility for weekends, overtime, and variable start times; strong preference for candidates open to working any shift (days, nights, weekends) based on business needs. Organizes and performs product release, stability and raw material testing under direct supervision. Performs testing within established timelines and in accordance with current specifications. Documents results clearly and accurately. Interprets results by complying to appropriate specification requirements. Perform data trending of critical product, process information and release test results to be used in SPC/ trend analysis. Maintains sufficient inventories off reagents and supplies. Assures compliance to company procedures, GMP, FDA, Safety and ISO regulations in all functions. Participate in laboratory investigations, technology transfer, validation and R&D projects. Performs additional work-related duties as assigned. Required: Bachelor's degree in Medical Technology, Clinical laboratory Science, Biology, Chemistry or related field of study. Associates in Medical Technology is acceptable. Knowledge and experience with Good Manufacturing Practices (GMP) Proficiency with Microsoft Office Suite of products Knowledge and experience with Good Documentation Practices (GDP) Pipetting Perform Indirect Antiglobulin Testing (IAT) Perform Direct Antiglobulin Testing (DAT) Grading Blood Bank reactions Perform Instrument maintenance Perform titrations Quality Control Reverse Blood grouping Blood Bank Tube Testing Blood Bank Instrument Testing Internal Partners: Strong working relationships with the site's Material Management, Quality, Upstream Formulation, EHS, Facilities, Engineering, Product Support are necessary to drive effective prioritization and collaboration to meet the needs of the business External Partners: Suppliers The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk, analyzing data, in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted. Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. Including sitting, standing, walking, bending, squatting, balancing (Maintaining body equilibrium to prevent falling when walking, standing or crouching on narrow, slippery or erratically moving surfaces. Amount and kind of balancing exceeds that needed for ordinary locomotion and maintenance of body equilibrium), and ability to lift up to 30lbs. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $48,000 to $68,000 annually and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as QuidelOrtho, we are seeking an Operations Shift Leader to work in our Pompano Beach, FL location. The Shift Leader is responsible for overseeing daytoday manufacturing operations during assigned shifts, ensuring production goals are met while maintaining compliance with quality, safety, and regulatory standards. This role provides frontline leadership, supports continuous improvement initiatives, and serves as a key liaison between operators, supervisors, and crossfunctional partners. Work Schedule: B-Shift (2:00pm -10:30pm) Lead and coordinate production activities to meet daily safety, quality, delivery, and productivity targets. Provide direction, guidance, and support to production operators during assigned shifts. Monitor adherence to GMP, FDA, ISO, and company quality standards Address production issues, escalate risks, and implement corrective actions as needed. Train, coach, and mentor employees to enhance performance and engagement. Support continuous improvement initiatives, including lean manufacturing and process optimization. Maintain accurate production documentation, shift reports and Systems Updates. .Perform other work-related duties as assigned Required High school diploma or equivalent required; associate degree or technical certification preferred Minimum of 3 years of experience in a regulated manufacturing environment (medical device, diagnostics, pharmaceutical preferred) 1-2 years of leadership or teamlead experience Working knowledge of GMP, FDA, and ISO quality systems Strong communication, problemsolving, and decisionmaking skills Ability to lead teams in a fastpaced manufacturing environment Proficiency with basic computer applications and manufacturing ERP Inventory Systems Ability to work assigned shifts, including weekends or overtime as required Preferred: Strong working knowledge and understanding of packaging and filling equipment. Experience with Microsoft office/SAP system. Internal Partners: Maintenance, Engineering, Quality, Warehouse External Partners: Suppliers The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be, standing, walking or sitting for extended periods of time. Ability to lift up to 50 lbs., frequent lifting of 21-30 lbs., and use force to pull or push up to 800 lbs. devices with wheels. PPE as required by the area. Ability to work a rotating shift schedule, overtime and weekends as needed to meet production requirements. Flexible work hours to meet project deadlines. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The hourly range for this position is $23.38 to $27.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as QuidelOrtho we are seeking a Production Manager to work in our manufacturing facility in Pompano Beach Florida. The Production Manager is responsible for overseeing the end-to-end production processes to ensure compliance with regulatory standards, operational efficiency, and product quality. This role demands strategic leadership, cross-functional coordination, and continuous improvement across manufacturing operations. This position will be located onsite in Pompano Beach, FL. Production Oversight: Direct all site-based activities across manufacturing and support functions to meet customer expectations and business goals. Regulatory Compliance: Ensure operations comply with QSR/GMP,FDA CBER, ISO standards, and other relevant medical device regulations. Strategic Planning: Develop and execute plans for new product introductions (NPI), technology transfers, and capital expenditures. Quality & Safety: Maintain inspection-ready conditions, lead emergency management actions, and uphold Health, Safety, and Environmental standards. Team Leadership: Build and manage high-performing teams, conduct performance reviews, and lead succession planning efforts. Perform other work-related duties as assigned. Required: Minimum Associate Degree or equivalent in a relevant subject. Minimum 5 years of experience in a manufacturing environment, with at least 2 years in a supervisory or lead role, preferably in medical device production. Strong understanding of production processes, regulatory requirements, and quality systems. Effective communication and interpersonal skills for team direction and stakeholder engagement. Ability to manage routine operational challenges, prioritize tasks, and maintain productivity. Commitment to upholding health, safety, and environmental standards. Preferred: Experience with SAP or similar ERP systems Data analysis and basic process optimization Basic project management skills Continuous improvement mindset Internal Partners: Production Manager, Quality, HSE, Planning, Raw Materials External Partners: Suppliers, Auditors, and regulatory Inspectors Work is primarily conducted in office and manufacturing settings, with regular movement between production areas. The role may involve exposure to controlled chemicals and requires adherence to safety protocols. Flexible working hours may be necessary to meet production demands; occasional overtime may be required. Mainly office-based with frequent movement to and from production areas. May involve standing for extended periods and occasional lifting of materials in compliance with safety guidelines. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as one QuidelOrtho we are seeking a Principal Quality Partner, Design and Tech Transfer Strategy (Assay). The Design and Tech Transfer Strategy Principal Quality Partner is a global individual contributor within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This individual is responsible to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. The Principal Quality Engineer for Design & Technology Transfer Strategy (Assay) serves as a senior technical leader within the Quality organization, responsible for driving robust, compliant, and efficient design transfer and technology transfer strategies for invitro diagnostic (IVD) assays. This role partners closely with cross functional teams-including R&D, Tech Transfer, Design Quality, and Operations-to ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations. The Principal Quality Partner provides authoritative interpretation of quality and regulatory requirements, deep product and process expertise, and proactive quality oversight to enable successful commercialization, lifecycle changes, and global inspection readiness.vitro diagnostic (IVD) assays. This role partners closely with crossfunctional teams-including R&D, Tech Transfer, Design Quality, and Operations-to ensure that new products and process changes are transferred seamlessly into manufacturing with full adherence to global regulatory expectations. This individual is responsible for fostering a culture of engagement, collaboration, and performance. By integrating technical expertise and data-driven insights, the Principal Quality Partner ensures that Quality systems deliver sustainable business and compliance outcomes. This position will be onsite in Rochester, NY. Serve as the primary Quality partner to the Technology Transfer team, providing strategic guidance and oversight throughout assay design transfer and tech transfer activities. Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant, sustainable product realization. Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing teams to ensure alignment on design transfer deliverables, risk management, and process capability expectations. Provide expert interpretation of applicable global regulatory and quality system requirements (e.g., ISO 13485, IVDR, FDA QSR) as they relate to design transfer, process transfer, verification/validation, and manufacturing readiness. Apply deep product and process knowledge to assess transfer risks, guide process understanding, and ensure adequate controls are defined and implemented during scaleup. Support global audit and inspection activities as a subject matter expert and auditee for design transfer, tech transfer, and related quality system elements. Proactively identify quality gaps, systemic risks, and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions. Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance. Perform other work-related duties as assigned. Required: Bachelor's degree in Life Sciences, Engineering, or a related technical discipline required. 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR. Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows. Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations. Excellent collaboration, influence, and communication skills across functional and organizational boundaries. Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement. Commitment to scientific integrity, compliance excellence, and continuous improvement. Expert-level knowledge of Design Transfer and Technology Transfer for IVD assays, including process readiness, scaleup, and transfer of product requirements into manufacturing. Deep understanding of IVD regulatory and quality system requirements, such as ISO 13485, IVDR, FDA QSR, risk management (ISO 14971), and design control principles. Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows. Ability to interpret complex regulatory requirements and translate them into actionable design transfer and quality strategies. Demonstrated experience evaluating process capability, process controls, and design outputs to ensure manufacturability and compliance. Preferred: Strong analytical and systemsthinking skills to evaluate endtoend product realization pathways. Ability to anticipate risks in design transfer and proactively implement mitigation strategies. Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline. Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools. Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise. Experience supporting or leading Health Authority or Notified Body inspections. Internal: Tech Transfer, Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact: Thrive Together - Collaborate intentionally, grow as a team Make It Happen - Focus on priorities, embrace continuous improvement Commit to Service - Cultivate a service mindset Embrace Inclusion - Be open and authentic, welcome diverse perspectives Salary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $135,000 to $175,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. As we continue to grow as QuidelOrtho, we are seeking an Operations Shift Leader to work in our Pompano Beach, FL location. The Shift Leader is responsible for overseeing daytoday manufacturing operations during assigned shifts, ensuring production goals are met while maintaining compliance with quality, safety, and regulatory standards. This role provides frontline leadership, supports continuous improvement initiatives, and serves as a key liaison between operators, supervisors, and crossfunctional partners. Work Schedule: A-Shift (6:00am -2:30pm) Execute manufacturing or manufacturing-support processes according to standard operating procedures. Lead and coordinate production activities to meet daily safety, quality, delivery, and productivity targets. Provide direction, guidance, and support to production operators during assigned shifts. Monitor adherence to GMP, FDA, ISO, and company quality standards Address production issues, escalate risks, and implement corrective actions as needed. Train, coach, and mentor employees to enhance performance and engagement. Support continuous improvement initiatives, including lean manufacturing and process optimization. Maintain accurate production documentation, shift reports and Systems Updates. .Perform other work-related duties as assigned Required High school diploma or equivalent required; associate degree or technical certification preferred Minimum of 3 years of experience in a regulated manufacturing environment (medical device, diagnostics, pharmaceutical preferred) 1-2 years of leadership or teamlead experience Working knowledge of GMP, FDA, and ISO quality systems Strong communication, problemsolving, and decisionmaking skills Ability to lead teams in a fastpaced manufacturing environment Proficiency with basic computer applications and manufacturing ERP Inventory Systems Ability to work assigned shifts, including weekends or overtime as required Preferred: Strong working knowledge and understanding of packaging and filling equipment. Experience with Microsoft office/SAP system. Internal Partners: Maintenance, Engineering, Quality, Warehouse External Partners: Suppliers The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be, standing, walking or sitting for extended periods of time. Ability to lift up to 50 lbs., frequent lifting of 21-30 lbs., and use force to pull or push up to 800 lbs. devices with wheels. PPE as required by the area. Ability to work a rotating shift schedule, overtime and weekends as needed to meet production requirements. Flexible work hours to meet project deadlines. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The hourly range for this position is $23.38 to $27.00 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-SP1

Job Description Summary Statement The Quality Assurance Coordinator assists the Chief Quality and Compliance Officer with oversight of the Quality Management System, (QA/QC, cGMP, cGTP, and cGLP) ensuring that systems and procedures are compliant with applicable federal and state laws and regulations and accreditation standards. Responsibilities: Under the guidance and direction of the Director, Quality Assurance and Regulatory Compliance, the Quality Assurance Coordinator shall: • Assist in promoting and maintaining a quality culture throughout the organization., • Conduct internal audits of WU and CT/ET donor charts and apheresis collection charts., • Ensure all department training is up to date and assign new training, as needed., • Assist with investigation and resolution of deviations, complaints and adverse reactions, as needed, • Maintain QA related documents and reports., • Participate in continual improvement activities to enhance the Quality Management System across all departments (Donor Services, Apheresis Center, Cellular Therapy Laboratory and Gift of Life Biologics)., • Develop a working knowledge of all areas of the organization and a clear understanding of the organization’s key functional processes and resources., • Fulfill other duties as assigned. Knowledge, Skills and Experience • 1-3 years of experience in Quality Assurance, • FDA cGmP(21 CFR 210 & 211) and Cgtp(21 CFR 1271) regulations, • Must be detail-oriented and demonstrate good documentation practices., • Demonstrate ability to manage and prioritize multiple projects and meet deadlines., • Possess strong oral and written customer service and communication skills. Must be able to remain calm and tactful when resolving problems involving all levels of staff, visitors, vendors, etc., • Adept at problem-solving and decision-making., • Flexible and adaptable to changing conditions., • Good project management skills., • Knowledge, training and experience in QA principles and data management systems., • Evidence of understanding and monitoring of compliance with SOPs., • Proficient in Microsoft Office Suite and other data management software., • Good time management, organizational skills and ability to set priorities., • Demonstrated ability to work independently as well as part of an integrated team.Schedule / Work Hours The hours for this position are 40 hours per week and are fully in office. Employees may work either a 4-day, 10-hour schedule or a 5-day, 8-hour schedule.

Job Description Job Title: Quality Regulatory Technician - Labeling Compliance Location: Miramar, FL Department: Quality Assurance / Regulatory Affairs Employment Type: Monday - Friday 8:30am - 5pm $19 - $22/ HR We are seeking a detail-oriented Quality Regulatory Technician to join our Quality Assurance team, specializing in labeling compliance. This role ensures that all product labels and packaging meet internal standards and adhere to local, state, federal, and international regulatory requirements. The ideal candidate is highly organized, collaborative, and experienced in dietary supplement labeling and packaging. MUST BE BILINGUAL ENGLISH/SPANISH. Key Responsibilities • Apply style guidelines and branding standards to new and revised product labels., • Ensure compliance of all labeling with applicable local, state, and federal regulations., • Create and revise label items in the company’s document control system; draft and release engineering change orders., • Support continuous improvement initiatives within the Labeling department., • Provide daily regulatory support for labeling strategies and operations across multiple projects., • Interpret and apply regulatory guidance to labeling within the dietary supplement industry for domestic and international markets., • Collaborate cross-functionally with teams including Engineering, Marketing, Quality, and R&D to support label and packaging updates and new product development., • Interface with distributors and stakeholders to resolve labeling/packaging issues., • Oversee the development and review of advertising and promotional materials for regulatory compliance., • Conduct proofreading and side-by-side reviews of primary and secondary labels, including multilingual inserts, for final artwork approval., • Manage and track labeling/packaging timelines and documentation for regulatory submissions and audits., • Communicate regulatory updates and interpret compliance directives for internal teams, offering solutions and guidance., • Provide support to Regulatory and Design teams and assist with additional regulatory duties as assigned. Qualifications • 2+ years of experience in regulatory labeling or packaging, preferably in the dietary supplement or consumer goods industry., • Strong knowledge of FDA regulations, FTC advertising guidelines, DSHEA, and international labeling standards., • Experience with document control systems and engineering change orders., • Excellent proofreading skills and attention to detail., • Strong organizational, multitasking, and communication skills., • Ability to collaborate in a fast-paced, cross-functional environment.

Job DescriptionSalary: $16-$19 per hour WE WILL TRAIN YOU IN ALL ASPECTS OF THE JOB Interested in joining the Medical Field and making a difference for the medical community? We could be a match! Continental Services Group, Inc. is looking for a Product Processor & Packer to join our Fort Lauderdale team. In this role, youll be responsible for processing blood units and preparing blood components for shipment. Youll work within our fast-paced manufacturing area, where consistency, speed, and attention to detail are critical. If you thrive in a collaborative environment and are looking for a full-time opportunity in a growing company, this might be the perfect fit for you! Key Responsibilities: • Process blood units from the donor room and prepare components for shipment., • Accurately label, assign, and handle blood units and samples in a timely manner., • Assist with labeling and prepping bags for phlebotomy., • Pack and prepare blood components for shipment according to customer specifications., • Check shipments for accuracy before dispatch., • Perform additional duties as assigned, including standing, sitting, and moving frequently throughout the day. Qualifications: • Previous experience in a manufacturing or laboratory environment is a plus, but not required., • Medical field experience is beneficial but not mandatorywe will train you!, • Strong reading and writing skills with attention to detail., • Bilingual (English/Spanish) is a plus but not required., • Ability to work in a fast-paced, team-oriented environment. What You Can Expect from Us: • Youll Be Treated Fairly-- We are a family-owned and operated company, and we consider each of our employees as part of our larger family. We operate and make our decisions based on merit, qualifications and performance., • Youll Be Challenged-- We hold very specialized and several regulatory licenses, which means our work environment is constantly evolving as agencies continue to update and improve their standards., • You'll have Phenomenal Hours-- We will not ask you to operate outside of our standard working hours, which are roughly 7:30am - 5:00pm. On Fridays, our working hours are roughly 7:30am-3:00pm. You will not be asked to work weekends, nights, or to be on call on any regular basis., • Youll Be Provided with Benefits-- After a probationary period, you have the option to partake in the health insurance plans we provide. You also will have the option to start a 401k, all expenses of setting up the account covered by us. What We Expect From You: • Communication - We feel this is the most important aspect of any job. You must be in communication with your supervisor, and make sure they are familiar and in agreement with your everyday tasks., • Timeliness - Everything we do--from shipping out specialty products to scheduling specific donors--is on a schedule. While we are very flexible in terms of time off and scheduling, we operate on the assumption that our employees will be timely, and if necessary, gives plenty of notice of their future absence., • Team Work - Our operations, testing and systems are complex and multifaceted, so we expect you to work well with our current team members--from those in the lab to those in administration--to ensure we work most cohesively., • Flexibility - We have two centers: our home office in Miami, and a second in Fort Lauderdale. We expect that if necessary, you are willing to work at either location, in the case of an emergency. Your gas and time would be compensated for a short period, if we ask that you work in a station that is not your home station. We also expect that youll be willing to jump in anywhere in the office where we might need you., • Willingness to Learn - While we expect youll come in with a variety of basic skills, we ask that you come also knowing youll learn a lot here. Salary & Benefits • Competitive salary within the field. Final determination will depend on experience level and qualifications., • Profit Sharing & 401k after 1-Full Year of Service - Fully funded and invested.All administrative and investment fees are paid for by Continental., • Health Insurance - A majority of the insurance fees is paid for by Continental. This includes gap, vision and dental insurance. We can talk to you about what kind of plan will work for you. About Continental Services Group Inc. We are an FDA-licensed company that has been in business for over 55 years. We provide blood components and other biological raw materials to our customers, who use the material for the further manufacturing of in-vitro diagnostic products. The vast majority of the product we sell is used for manufacturing test kits and controls, which are used in hospitals around the world. Holding some of the industry's most specialized certifications, we draw the blood and other raw material from a wide base of donors, a majority of which repeatedly and consistently visits every 56 days. This repeat-donor base allows us to provide extensively tested and unique products to the pharmaceutical industry. Continental has been an FDA licensed facility since 1971, holding multiple city, state and federal licenses. Our laboratory is CLIA certified since 1971, and ourfacilities have beenISO 9001 certified since 2003.Continental Services Group is an Equal Opportunity Employer and maintains a smoke and drug-free workplace. All offers of employment are contingent upon successful completion of drug and background checks.

AML/BSA program evaluation) - Provide structured feedback on AI accuracy in areas such as regulatory standards (FINRA, OCC, FFIEC, FDA, SEC, GDPR, HIPAA), risk frameworks (COSO, ISO 31000), and industry-specific compliance terminology - Collaborate asynchronously with research teams to refine evalua

Have strong experience with one or more of: AML/BSA, OFAC sanctions screening, FCPA/anti-corruption, healthcare regulatory (HIPAA, Stark Law, Anti-Kickback Statute, Medicare/Medicaid), FDA submissions, privacy (GDPR/CCPA/PIA/DPIA), environmental permitting, export control, or administrative hearings

Job Description About the Role SurGenTec is an emerging spine and orthopedic biologics company headquartered in Boca Raton, FL, built around a next-generation cortical fiber platform — including OsteoFlo HydroFiber — that is redefining bone-healing technology. We are seeking a hands-on Marketing Communications Manager who can translate complex procedural and clinical science into compelling, FDA-compliant content across surgeon, distributor, and patient-facing channels. This is not a generalist marketing role. The ideal candidate has deep familiarity with spine, SI joint fusion, lumbar biologics, or cervical procedures; understands how surgeons consume clinical information; and has built the full spectrum of medical device marcom deliverables — from surgical technique guides to trade show booth copy to regulatory-reviewed promotional decks. You will report to the Director of Marketing and work in close coordination with the Director of Clinical Education, the VP of International Sales, and the field distributor network. Reports To Director of Marketing Travel ~15–20% (trade shows, field) Experience 5–7 years (med device req.) Location Boca Raton, FL (on-site) Education Bachelor's req.; MBA/MS a plus Focus Areas Spine, SI Joint, Lumbar Biologics What You Will Own The following represents the primary deliverable categories this role is accountable for producing, managing, and maintaining: Clinical & Surgeon-Facing Content • Surgical technique guides and step-by-step procedural brochures, • Clinical evidence summaries, white paper abstracts, and reprint packaging, • Mechanism-of-action (MOA) videos — scripting, vendor direction, and post-production review, • KOL and surgeon case study writeups in collaboration with the Clinical Education team, • IRB/study patient recruitment materials (MLR-reviewed), • Procedure-centric content framing the clinical problem, not just the product Sales Enablement & Distributor Channel Tools • Full product launch kits (typically 8–12 component packages per product area), • Distributor sales decks, leave-behinds, and territory-level promotional materials, • Competitive comparison matrices, properly framed within FDA promotional guidance, • Objection-handling one-pagers for field reps, • Training materials and onboarding content for new distributors, • Co-branded materials with distributor partners (compliant versions) Digital & Web Content • Procedure-area landing pages and website copy in partnership with web/design vendors, • HCP-targeted email campaigns and nurture sequences, • LinkedIn and social content calendar within FDA guardrails, • SEO-oriented clinical content in plain language Trade Show & Event Materials • Booth design briefs, panel copy, and signage for NASS, ORS, SMISS, and regional meetings, • Symposium and surgeon dinner event collateral, • Speaker slide decks for KOL faculty programs (MLR-reviewed), • Post-show follow-up content packages for field reps Regulatory-Adjacent & MLR Process • Submission packages for Medical-Legal-Regulatory (MLR) review of promotional materials, • Claims substantiation matrices linking promotional statements to cleared indications and clinical data, • 510(k) summary layperson narrative support as needed, • Version control and archiving of all approved promotional materials per SOP Key Responsibilities • Develop and execute integrated marcom plans aligned with procedure-area commercial priorities (OsteoFlo HydroFiber, SI joint, lumbar, cervical), • Own end-to-end production of all clinical, sales enablement, and digital content — from brief through MLR approval to field distribution, • Manage external agency, design, print, and video production vendor relationships; own budgets and timelines, • Maintain a compliant promotional material library with version control and expiration tracking, • Partner with the Director of Clinical Education to ensure procedural accuracy and surgeon-appropriate tone in all clinical assets, • Partner with the VP of International Sales to develop region-specific materials compliant with local regulatory frameworks, • Support product launch planning including launch kit development, field training content, and go-to-market messaging, • Coordinate logistics and materials for trade shows, symposia, and company events, • Monitor competitive messaging across Medtronic, Stryker, NuVasive, and emerging biologics players; brief leadership on shifts, • Track and report on content performance, campaign metrics, and field adoption of marcom tools Required Skills & Competencies Medical Device Marketing — Hard Skills • Proficiency in Adobe Creative Suite: InDesign (print layout), Illustrator (graphics), and Acrobat Pro (PDF review and annotation), • Working knowledge of 21 CFR Part 801, FDA promotional guidance for devices, and off-label communication guardrails, • Demonstrated experience navigating a Medical-Legal-Regulatory (MLR) review workflow, • Clinical claims substantiation — ability to read a clinical abstract and determine what is and is not a supportable promotional claim, • Video production coordination: script development, directing production vendors, reviewing cuts for compliance and accuracy, • CRM/marketing automation familiarity (HubSpot, Salesforce Marketing Cloud, or equivalent), • Website CMS experience (WordPress, Webflow, or similar) for content updates and landing page builds, • Canva or equivalent for rapid-cycle field collateral production, • Project management tools (Asana, Monday.com, or similar) for deadline and deliverable tracking Medical & Scientific Literacy • Medical writing aptitude: ability to read and distill peer-reviewed literature, clinical study summaries, and 510(k) data, • Familiarity with spine anatomy, common procedures (TLIF, PLIF, ALIF, SI joint fusion, vertebral body replacement), and the biologics continuum (autograft, allograft, DBM, synthetic), • Understanding of the surgical decision workflow — how surgeons evaluate new products and what clinical evidence they need to change behavior Strategic & Interpersonal • Procedure-centric marketing orientation — leads with the clinical problem, not the product feature list, • Distributor channel fluency — able to create materials that work for 1099 independent reps, not just a direct sales force, • Cross-functional stakeholder management across Sales, R&D, Regulatory, and Clinical Education in an MLR environment, • Ability to manage multiple simultaneous deliverables in a fast-moving, resource-constrained environment, • Confident verbal communicator — able to present marcom strategy and campaign plans to senior leadership Qualifications Required • Bachelor's degree in Marketing, Communications, Life Sciences, or a related field, • 5–7 years of marketing communications experience in the medical device or biologics industry — required, not preferred, • Demonstrated experience delivering a full product launch, including surgeon-facing and sales enablement assets, • Proven track record working with independent distributor channels (not just a direct sales force), • Strong FDA promotional compliance foundation — able to identify a compliance issue without needing Legal to flag it first, • Portfolio of medical device marcom deliverables available for review (surgical technique guides, sales decks, event materials, digital content) Preferred • Advanced degree: MBA, MS in Communications, or MS in Life Sciences, • Spine, orthopedics, or biologics category experience (NASS/ORS/SMISS conference familiarity a strong plus), • Experience at an early-commercial or growth-stage device company, • Knowledge of international medical device regulatory frameworks (EU MDR, ANVISA, Health Canada), • Project management certification (PMP or equivalent) About SurGenTec SurGenTec is a privately held, growth-stage spine and orthopedic medical device company based in Boca Raton, Florida. Our commercial portfolio spans SI joint fusion, lumbar biologics, and cervical fusion — anchored by OsteoFlo HydroFiber, a next-generation cortical fiber bone graft technology designed to set a new standard in spinal fusion biology. We operate through a national independent distributor network and are expanding internationally. The people who thrive here take ownership, bring clinical credibility to their marketing work, and are motivated by building something that genuinely improves patient outcomes. SurGenTec offers a competitive compensation package including health insurance, 401(k), and paid time off.

Job DescriptionMarketing Communications Manager Our client is an emerging spine and orthopedic biologics company headquartered in Boca Raton, FL, built around a next-generation cortical fiber platform that is redefining bone-healing technology. We are seeking a hands-on Marketing Communications Manager who can translate complex procedural and clinical science into compelling, FDA-compliant content across surgeon, distributor, and patient-facing channels. This is not a generalist marketing role. The ideal candidate has deep familiarity with spine, SI joint fusion, lumbar biologics, or cervical procedures; understands how surgeons consume clinical information; and has built the full spectrum of medical device marcom deliverables — from surgical technique guides to trade show booth copy to regulatory-reviewed promotional decks. You will report to the Director of Marketing and work in close coordination with the Director of Clinical Education, the VP of International Sales, and the field distributor network. Reports To Director of Marketing Travel ~15–20% (trade shows, field) Experience 5–7 years (med device req.) Location Boca Raton, FL (on-site) Education Bachelor's req.; MBA/MS a plus Focus Areas Spine, SI Joint, Lumbar Biologics What You Will Own The following represents the primary deliverable categories this role is accountable for producing, managing, and maintaining: Clinical Surgeon-Facing Content Surgical technique guides and step-by-step procedural brochures Clinical evidence summaries, white paper abstracts, and reprint packaging Mechanism-of-action (MOA) videos — scripting, vendor direction, and post- production review KOL and surgeon case study writeups in collaboration with the Clinical Education team IRB/study patient recruitment materials (MLR-reviewed) Procedure-centric content framing the clinical problem, not just the product Sales Enablement Distributor Channel Tools Full product launch kits (typically 8–12 component packages per product area) Distributor sales decks, leave-behinds, and territory-level promotional materials Competitive comparison matrices, properly framed within FDA promotional guidance Objection-handling one-pagers for field reps Training materials and onboarding content for new distributors Co-branded materials with distributor partners (compliant versions) Digital Web Content Procedure-area landing pages and website copy in partnership with web/design vendors HCP-targeted email campaigns and nurture sequences LinkedIn and social content calendar within FDA guardrails SEO-oriented clinical content in plain language Trade Show Event Materials Booth design briefs, panel copy, and signage for NASS, ORS, SMISS, and regional meetings Symposium and surgeon dinner event collateral Speaker slide decks for KOL faculty programs (MLR-reviewed) Post-show follow-up content packages for field reps Regulatory-Adjacent MLR Process Submission packages for Medical-Legal-Regulatory (MLR) review of promotional materials Claims substantiation matrices linking promotional statements to cleared indications and clinical data 510(k) summary layperson narrative support as needed Version control and archiving of all approved promotional materials per SOP Key Responsibilities Develop and execute integrated marcom plans aligned with procedure-area commercial priorities (OsteoFlo HydroFiber, SI joint, lumbar, cervical) Own end-to-end production of all clinical, sales enablement, and digital content — from brief through MLR approval to field distribution Manage external agency, design, print, and video production vendor relationships; own budgets and timelines Maintain a compliant promotional material library with version control and expiration tracking Partner with the Director of Clinical Education to ensure procedural accuracy and surgeon-appropriate tone in all clinical assets Partner with the VP of International Sales to develop region-specific materials compliant with local regulatory frameworks Support product launch planning including launch kit development, field training content, and go-to-market messaging Coordinate logistics and materials for trade shows, symposia, and company events Monitor competitive messaging across Medtronic, Stryker, NuVasive, and emerging biologics players; brief leadership on shifts Track and report on content performance, campaign metrics, and field adoption of marcom tools Required Skills Competencies Medical Device Marketing — Hard Skills Proficiency in Adobe Creative Suite: InDesign (print layout), Illustrator (graphics), and Acrobat Pro (PDF review and annotation) Working knowledge of 21 CFR Part 801, FDA promotional guidance for devices, and off-label communication guardrails Demonstrated experience navigating a Medical-Legal-Regulatory (MLR) review workflow Clinical claims substantiation — ability to read a clinical abstract and determine what is and is not a supportable promotional claim Video production coordination: script development, directing production vendors, reviewing cuts for compliance and accuracy CRM/marketing automation familiarity (HubSpot, Salesforce Marketing Cloud, or equivalent) Website CMS experience (WordPress, Webflow, or similar) for content updates and landing page builds Canva or equivalent for rapid-cycle field collateral production Project management tools (Asana, Monday.com, or similar) for deadline and deliverable tracking Medical Scientific Literacy Medical writing aptitude: ability to read and distill peer-reviewed literature, clinical study summaries, and 510(k) data Familiarity with spine anatomy, common procedures (TLIF, PLIF, ALIF, SI joint fusion, vertebral body replacement), and the biologics continuum (autograft, allograft, DBM, synthetic) Understanding of the surgical decision workflow — how surgeons evaluate new products and what clinical evidence they need to change behavior Qualifications Required Bachelors degree in Marketing, Communications, Life Sciences, or a related field 5–7 years of marketing communications experience in the medical device or biologics industry — required, not preferred Demonstrated experience delivering a full product launch, including surgeon- facing and sales enablement assets Proven track record working with independent distributor channels (not just a direct sales force) Strong FDA promotional compliance foundation — able to identify a compliance issue without needing Legal to flag it first Portfolio of medical device marcom deliverables available for review (surgical technique guides, sales decks, event materials, digital content) Our client offers a competitive compensation package including health insurance, 401(k), and paid time off. Compensation Range $116,000 / $130,000 Annual Salary + Benefits 401K, Health, Vision, Dental Insurance and paid time off. Please email resume to : Sheila@mykeystaff.com #KT

Job DescriptionSalary: $15-18 per hour; Dependent on Experience & Skills Continental is looking for individuals who are interested in working in the medical field by helping our teams process volunteer Blood and Plasma donors. Continental has been in business for over 56 years, serving otherwise underserved communities, while also making an impact to the global medical supply of blood products! The positions available allow you to make a real difference in peoples' lives, everyday. Ideal candidates are professionally flexible with their work environment and are able to learn a variety of tasks that help us properly service our blood donors. Ideal candidates must (1) have a strong customer service skills to ensure the experience for all our blood donors is a good one, (2) be willing to learn various tasks within the "Donor Services" area, and (c) be team-oriented. Expectations of individuals in this role include ensuring each potential blood donor is treated well, and are processed safely, efficiently, and within the applicable regulations. Responsibilities of the Role Include: • Taking the blood pressure, pulse, temperature and other vitals of possible donors, • Asking all FDA-required questions to make sure each donor is eligible and safely processed, • Ensuring donors hematocrit levels and repeat-donation dates are up to FDA standards, • Assigning donors to a specific section of our complex list of products, • Answering any questions or concerns blood donors may have during the process, • Youll also have the potential to perform phlebotomies after you have learned the donor processing stream; this often will occur approximately 6 months or longer after initial employment, • If you have had previous phlebotomy experience, we will work with you to best suit your skills with our needs and yours Ideal Candidates Meet the Following Requirements: • Must fluently speak, understand and write English, • Must have basic proficient computer skills (Able to navigate basic computer prompts), • May havepreviously demonstrated exceptional customer service in another work environment, • May havea background and interest in the medical health field, • Being bilingual - Spanish and English - a plus, • EMT or LPN certification is a plus! What You Can Expect from Us: • Youll Be Treated Fairly-- We are a privately owned and operated business, and we consider each of our employees as part of our larger family. We operate and make our decisions based on merit, qualifications and performance., • Youll Be Challenged-- We hold very specialized and several regulatory licenses, which means our work environment is constantly evolving as agencies continue to update and improve their standards., • Youll Be Provided with Benefits-- After a probationary period, you have the option to part take in the health insurance we provide. After one year of service, you also will have the option to enroll in our 401k and profit sharing programs. What We Expect From You: • Communication- We feel this is the most important aspect of any job. You must be in communication with your supervisor, and make sure they are familiar and in agreement with your everyday tasks., • Timeliness- Everything we do--from shipping out specialty products to scheduling specific donors--is on a schedule. While we are very flexible in terms of time off and scheduling, we operate on the assumption that our employees will be timely, and if necessary, gives plenty of notice of their future absence., • Team Work- Our operations, testing and systems are complex and multifaceted, so we expect you to work well with our current team members--from those in the lab to those in administration--to ensure we work most cohesively., • Flexibility- We have two centers: our home office in Miami, and a second in Fort Lauderdale. We expect that if necessary, you are willing to work at either location, in the case of an emergency. Your gas and time would be compensated for a short period, if we ask that you work in a station that is not your home station. We also expect that youll be willing to jump in anywhere in the office where we might need you., • Willingness to Learn- While we expect youll come in with a variety of basic skills, we ask that you come also knowing youll learn a lot here. Salary & Benefits • Competitive salarywithin the field. Final determination will depend on experience level and qualifications., • 401k & Profit Sharing Programs - This is eligible for employees to enroll in, after 1 year of service with CSG. All administrative and investment fees are paid for by Continental., • Health Insurance- A majority of the insurance fees is paid for by Continental. We can talk to you about what kind of plan will work for you and your family., • LifeInsurance Policy-We offer a life insurance policy for each of our employees, and this cost is covered completely by CSG. About Continental Services Group Inc. We are an FDA-licensed company that has been in business for over 53 years. We provide blood components and other biological raw materials to our customers, who use the material for the further manufacturing of in-vitro diagnostic products. The vast majority of the product we sell is used for manufacturing test kits and controls, which are used in hospitals around the world. Holding some of the industry's most specialized certifications, we draw the blood and other raw material from a wide base of donors, a majority of which repeatedly and consistently visits every 56 days. This repeat-donor base allows us to provide extensively tested and unique products to the pharmaceutical industry. Continental has been an FDA licensed facility since 1971, holding multiple city, state and federal licenses, and has been ISO certified since 2003.Continental Services Group is an Equal Opportunity Employer and maintains a smoke and drug-free workplace. All offers of employment are contingent upon successful completion of drug andbackgroundchecks.