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Job Description Job Description – Visual Inspection Clerk (503B Compounding Industry) Position Summary The Visual Inspection (VI) Clerk supports the quality assurance and production teams in the inspection, documentation, and disposition of sterile injectables, hormone pellets, and container-closure systems. This role ensures compliance with FDA 503B outsourcing facility regulations, cGMP, USP standards (<797>, <800>, <1207>, etc.), and internal SOPs. The VI Clerk performs critical quality control functions to safeguard patient safety while assisting with ancillary non-technician tasks in support of daily operations. This is a full time in person position M-F in Irving, TX. Key Responsibilities Visual Inspection of Sterile Injectables • Perform 100% manual visual inspection of filled vials, syringes, and IV bags for particulate matter, container integrity, cosmetic defects, and proper fill levels., • Operate under validated lighting conditions and time limits as defined by PDA and internal SOPs., • Document inspection outcomes, segregating conforming and non-conforming units according to quality standards., • Escalate critical or recurring defects to Quality Assurance or Area Supervisor/Manager. Hormone Pellet Inspection • Inspect pressed hormone pellets for size, weight, shape, and surface integrity per established specifications., • Document acceptance/rejection results in batch records and logbooks., • Assist in packaging preparation under controlled conditions. Container-Closure System Oversight • Inspect vials, stoppers, and seals prior to use for cleanliness and defects., • Verify container-closure integrity post-processing using approved inspection methods. Documentation & Compliance • Complete real-time data entry in batch records, inspection logs, and quality forms., • Maintain GDP compliance (legible, contemporaneous, attributable records)., • Participate in deviation reporting and provide inspection-related input for investigations. Other Support Tasks • Stage components, supplies, and inspection tools for daily operations., • Perform equipment cleaning, calibration checks, and inspection station setup., • Provide clerical support such as filing, logbook maintenance, and controlled document handling. Qualifications • High school diploma or equivalent required; Associate’s degree or higher preferred., • Prior experience in a cGMP or 503B/503A compounding environment preferred., • Knowledge of aseptic processing, sterile drug products, or hormone pellet manufacturing desirable., • Strong attention to detail and ability to work in controlled environments., • Ability to read and follow SOPs, quality standards, and regulatory requirements., • Comfortable with repetitive tasks under defined lighting/time conditions. Competencies • Regulatory Compliance: Familiarity with cGMP, FDA 503B guidance, and USP chapters., • Attention to Detail: Consistently identifies product defects and maintains accuracy in records., • Collaboration: Works effectively with QA, Production, and Packaging staff., • Adaptability: Supports both inspection duties and ancillary operational tasks., • Quality Mindset: Prioritizes patient safety and product quality in all activities. Physical & Environmental Requirements • Ability to sit/stand for extended inspection sessions (per PDA time-limit guidance)., • Manual dexterity for handling small units (vials, syringes, pellets)., • Work in cleanroom gowning environments (ISO-classified areas).

Job Description Quality Assurance Associate – Doc Control JOB DESCRIPTION: The ideal candidate can work cohesively and effectively with others to deliver excellence in written/verbal communications, planning, documenting, organizing, and executing multiple tasks simultaneously in a high pace environment. May conduct other quality tasks as required. Primary Document Control and Label Control Duties: • Scan, upload, and store batch records, forms, and quality events in designated location., • Manage, oversee, and perform Document Control Duties, • Administer the creation, review, approval, distribution, and archival of controlled documents (SOPs, protocols, reports, forms, batch records, policies, etc.)., • Manage revision control, superseded documents, and document retention, both physical copies and online, in alignment with regulatory requirements and internal policies., • Coordinate with document change owners for timely revision closure., • Coordinate with operations to ensure training completion associated with document changes., • Manage, oversee, and perform Change Management Duties., • Circulate documents for approval for Change Management Systems., • Log and track Change Management Documents., • Document actions appropriately following good documentation practices., • Maintain audit-ready document archives for FDA inspections, state board of pharmacy audits, and third-party quality audits., • Ensure compliance with FDA, USP <1083>, USP <800>, and applicable cGMP standards for sterile compounding facilities., • Perform Batch Issuance and Label Control Duties, including printing labels and batch records, and assisting with label reconciliation., • Author quality events, as assigned., • Assist Quality Department during regulatory inspections., • Create and revise Raw Material Specifications and Finished Product Specifications, as assigned., • Perform additional duties as required and assigned. Qualifications: · Bachelor’s Degree or higher in a life science or related disciple or 3 years GMP experience · Strong attention to detail · Knowledge of FDA, CFR, and USP guidelines · Excellent oral and written communication skills · Responsiveness, reliability, ability to express assurance/confidence, professionalism. · Team-oriented and customer service focused. · PC skills in Windows-based applications, ability to learn new software. Confidentiality The employee must maintain the confidentiality of company information and, pursuant to State and Federal Law (including the Health Insurance Portability and Accountability (HIPAA) Act of 1996), protected health information. EOE/ADA Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Carie Boyd Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Company DescriptionWe specialize in compounding office-use and personalized prescription medications.We specialize in compounding office-use and personalized prescription medications.

Job Description Quality Assurance Associate – Review & Disposition About Us: Carie Boyd Pharmaceuticals is a national 503B FDA outsourcing registered facility, enabling us to meet the needs of our patients and prescribers through a variety of office use products including but not limited to injectables, pellets, and topicals. Being a member of the Carie Boyd team means prioritizing patient needs, dedication to quality, and the drive to continue to scale our innovative business in new and diverse ways. JOB DESCRIPTION: The ideal candidate can work cohesively and effectively with others to deliver excellence in written/verbal communications, planning, documenting, organizing, and executing multiple tasks simultaneously in a high pace environment. May conduct other quality tasks as required. Primary Review and Disposition Duties Include: • Perform batch record review and disposition for product types as assigned., • Perform Finished Product AQL., • Update status of finished product., • Review and approve quality events, as assigned., • Write Quality Event Reports, as assigned., • Write Annual Quality Reports (AQR), as assigned., • Perform Quality Review of AQR and Annual Product Reviews (APR), • Attend meetings to coordinate and discuss disposition schedule., • Document actions appropriately following good documentation practices., • Assist Quality Department during regulatory inspections. As Needed, Document Control and Label Control Duties: • Scan batch records, forms, and quality events., • Perform Document Control Duties., • Store documents in appropriate location on SharePoint., • Perform Change Management Duties., • Circulate documents for approval for Change Management Systems., • Log and track Change Management Documents., • Modify controlled documents, as required., • Document actions appropriately following good documentation practices., • Perform Label Control Duties, including printing labels and batch records, and assisting with label reconciliation., • Stage materials to be shipped for testing. · Bachelor’s Degree or higher in a life science or related disciple or 5 years GMP experience · 3+ years in a quality role · Preferred experience of review & disposition or working directly in sterile environment · Strong attention to detail · Knowledge of FDA and USP guidelines · Excellent oral and written communication skills · Responsiveness, reliability, ability to express assurance/confidence, professionalism. · Team-oriented and customer service focused. · PC skills in Windows-based applications, ability to learn new software Confidentiality The employee must maintain the confidentiality of company information and, pursuant to State and Federal Law (including the Health Insurance Portability and Accountability (HIPAA) Act of 1996), protected health information. EOE/ADA Carie Boyd Pharmaceuticals is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, Carie Boyd Pharmaceuticals will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. Company DescriptionWe specialize in compounding office-use and personalized prescription medications.We specialize in compounding office-use and personalized prescription medications.

Job Description We are seeking a Mechanical Engineer to join our team in the design, development, and manufacturing of innovative medical devices. The ideal candidate will bring strong technical expertise in mechanical engineering, hands-on experience with product development, and a passion for creating safe and effective solutions that improve patient outcomes. Key Responsibilities * Design and develop mechanical components, assemblies, and systems for medical devices. * Perform CAD modeling, prototyping, and testing of mechanical designs. * Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory) to ensure compliance with medical device standards (ISO 13485, FDA). * Conduct tolerance analysis, FEA, and risk assessments to support robust product design. * Prepare technical documentation including design history files, test protocols, and reports. * Support verification & validation activities, root cause analysis, and design changes. * Contribute to continuous improvement in product performance and manufacturability. Qualifications * Bachelor’s degree (or higher) in Mechanical Engineering or related field. * 2–5 years of experience in mechanical design, preferably in the medical device or regulated industry. * Proficiency in CAD software (SolidWorks, Creo, or similar). * Knowledge of materials, manufacturing processes (injection molding, machining, additive manufacturing, etc.). * Understanding of design controls, risk management, and regulatory requirements. * Strong problem-solving skills and ability to work in a collaborative team environment. Preferred Skills * Experience with Class II/III medical devices. * Knowledge of GD&T, FEA, and DFMEA. * Hands-on experience with prototyping and testing. * Familiarity with cleanroom manufacturing environments. Thanks Suchi Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Job Description Now Hiring a Document Control Specialist in Irving, TX. Join our team today! Job Purpose: The Quality Assurance Supervisor is part of the clients Quality Assurance team. The Kitchen QA Supervisor will maintain and supervise Quality Assurance procedures in Food manufacturing operations of Ready to Eat Products. Kitchen QA Supervisor will help oversee applications of the comprehensive quality and food safety programs as well as being point of contact for any regulatory inspections. Shift: TBD Pay: $70-$80K Benefits: Medical, Dental, AD&D Essential Duties and Responsibilities: • Develop, implement, and maintain the company’s document control system for policies, procedures, forms, SOPs, and work instructions., • Ensure documents are reviewed, approved, issued, and archived according to company and regulatory requirements., • Maintaining version controls and prevents use of obsolete documents., • Track document changes and maintain revision histories., • Ensure documentation meets the requirements of applicable standards (e.g., SQF, HACCP, FSMA, FDA, USDA)., • Support internal and external audits by retrieving, organizing, and presenting documentation., • Ensure proper retention and disposal of records according to legal and regulatory timelines., • Distribute controlled documents to relevant departments and ensure staff are trained on updates., • Assist in developing and maintaining document control training materials., • Communicate changes to procedures or policies in a timely and effective manner., • Maintain both physical and electronic filing systems for records, logs, and certificates., • Verify completeness and accuracy of production, quality, and food safety records., • Participate in system reviews to identify opportunities for process and efficiency improvements., • Recommend enhancements to document control procedures to meet evolving regulatory and operational needs., • Other tasks as assigned Education and/or Experience: • Associate or bachelor’s degree in food science, Quality Assurance, Business Administration, or related field preferred., • 2–4 years of document control experience, preferably in a food manufacturing orregulated industry., • Knowledge of food industry regulations and certification programs (SQF, BRCGS, HACCP, FSMA)., • Strong attention to detail and organizational skills., • Proficiency in Microsoft Office Suite and document control software., • Ability to manage multiple priorities under tight deadlines. Additional Comments: • Assure that Minimum Vendor GMP and Food Safety Requirements are met, • Conduct internal audits of Kitchen operations and maintain 3 rd party audit preparedness, • Conducts timely investigations of all customer store complaints, • Point of contact for all regulatory agencies, including but not limited to FDA, USDA, State, County and City Health inspectors. Computer Skills: • Strong computer skills required; with knowledge in MS Office, Excel and WMS system literacy, • SAP, • WMS/Gold system literacy. Reasoning Ability: • Must be able to interact with all levels of management and have excellent written and verbal communication skills. Must be able to manage and lead a diverse workforce. Physical Requirements and Working Conditions: The physical demands described below are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the job. #IND-L

Job Description JOB LOCATION/SCHEDULE: Monday – Friday / On-Site / Irving, TX COMPANY OVERVIEW: Alliance Clinical Network we’re people with a purpose, dedicated to advancing medical innovation and healing technology through groundbreaking research. We bring our energy and our passion to improving patient lives every day. SUMMARY: The Associate Director of eSource Development is responsible for managing the development and implementation of electronic source (eSource) solutions for clinical trials, ensuring that systems are optimized for efficiency and compliance. ESSENTIAL DUTIES AND RESPONSIBILITIES • Lead, manage, and mentor the eSource development team to ensure the successful implementation of electronic data capture solutions across all clinical trials., • Provide strategic direction, set performance goals, and foster a collaborative team environment, • Oversee the design, development, and maintenance of eSource systems to capture clinical trial data efficiently and accurately, ensuring compliance with GCP, FDA, and other regulatory guidelines., • Work closely with clinical operations, regulatory, and data management teams to integrate eSource platforms into the broader clinical trial workflow, • Continuously evaluate and enhance eSource processes to improve data accuracy, accessibility, and study efficiency. Implement best practices for system integration, data validation, and compliance., • Abstract data from research protocols and build into internal study shell., • Ensure that the eSource development team and clinical research staff are trained eSource systems, protocols, and workflows. Develop training materials and provide ongoing support to team members., • Develop and track performance metrics for eSource systems, analyzing data to inform decision-making and drive continuous improvement 11), • Meet assigned targets, goals and completion deadlines., • Utilize analytical, problem solving and critical thinking., • Comply with all company policies, procedures, and conduct., • Strictly adhere to confidentiality and compliance standards. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and EXPERIENCE: • Bachelor’s degree in Information Technology, Life Sciences, Clinical Research, or a related field (Master’s degree preferred)., • Minimum of 8 years of experience in clinical research, with at least 3 years in eSource or electronic data capture (EDC) system development and implementation., • Strong understanding of clinical trial processes, GCP, FDA regulations, and electronic data capture technologies., • Experience managing teams and cross-functional collaboration, with a proven ability to lead and motivate technical staff in a fast-paced environment., • Excellent communication, project management, and problem-solving skills., • Knowledge of financial principles and experience working with study budgets is highly desirable., • Strong attention to detail., • Must be able to prioritize competing demands., • Must possess excellent verbal and written communication skills., • A proven ability to multi-task in a rapidly changing environment. BENEFITS: • 401 (k) Retirement Plan, • Medical, Dental, and Vision Insurance, • Paid Time Off (PTO), • Floating Holidays And more!

Job DescriptionDescription: We’re looking for a Quality Supervisor reports directly to the Quality Manager to help lead and continuously improve our plant quality and food safety systems. You’ll be responsible for driving compliance with regulatory standards, building a culture of quality across departments, and enhancing product consistency and customer satisfaction. This role will focus on leadership, systems implementation, and cross-functional collaboration to ensure we meet the highest standards in beverage production. • Lead implementation and management of quality systems, including ISO, HACCP, FDA, and third-party certifications, • Supervise and develop quality assurance staff, fostering a team-oriented and accountable environment, • Monitor and analyze quality KPIs, consumer complaints, and product performance to identify trends and drive improvements, • Partner with production, supply chain, and R&D teams to support new product launches and process changes, • Lead internal audits, regulatory inspections, and third-party reviews, ensuring full compliance with applicable standards, • Promote continuous improvement using Lean Six Sigma, TPM, or other industrial engineering methodologies, • Oversee training, documentation, and standard operating procedures to support food safety and quality standards, • Investigate root causes of quality issues and lead corrective/preventive action plans (CAPA) across departmentsRequirements:, • Bachelor's degree required, with 5+ years of progressive quality assurance experience in manufacturing, including at least 3 years in a supervisory or management role, • Proven experience leading ISO, HACCP, and FDA/USDA food safety and regulatory compliance programs in a production environment, • Strong planning, organization, and multitasking abilities, with demonstrated success managing cross-functional initiatives and audits, • Hands-on leadership approach with a track record of building high-performing teams and creating a culture of quality and accountability, • Skilled in applying Lean Six Sigma, TPM, or industrial engineering methodologies to improve product quality and process efficiency, • Strong analytical mindset with the ability to drive data-based decisions, implement quality metrics, and lead root cause and CAPA initiatives, • Excellent communication and collaboration skills to align quality efforts with production, supply chain, and other internal departments, • Preferred: Alcohol beverage or CPG industry experience; supply chain and organizational development background; bilingual in English and Spanish is a plus, • Huge Plus: APICS Certification or Six Sigma Certification

Job DescriptionDescription: Job Brief We are seeking an experienced Sr. Design Engineer to provide leadership support to our Spinal Hardware Products team within the R&D department. The Senior Design Engineer will be responsible for the design, development, verification and validation of new and existing products for our spinal hardware portfolio. This role requires a strong technical background in mechanical engineering, desire to grow in leadership and the ability to collaborate effectively across teams. The Sr. Design Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements in the spinal medical device sector. Responsibilities • Primary leader of assigned product development and sustaining projects., • Collaborate with cross-functional teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to achieve project goals and timelines., • Execute on the design, development, verification, and validation of new products, ensuring alignment with market needs and regulatory requirements., • Execute detailed mechanical component and assembly CAD models., • Generate detailed product drawings and component specifications., • Manage design transfer activities from R&D to manufacturing, optimizing processes and ensuring scalability., • Manage and prioritize sustaining engineering efforts for existing products, addressing design improvements, and manufacturing optimizations., • Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data., • Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) for medical devices., • Collaborate with Regulatory Affairs to support regulatory submissions., • Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field., • Minimum 5 years of experience in engineering roles within the medical device industry., • Strong background in medical device product development, including design, testing, and manufacturing processes., • Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management., • Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis)., • Experience with contract manufacturer development and working relationships., • Experience with implantable medical devices or surgical instrumentation., • Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles., • Excellent organizational and communication skills., • Ability to prioritize tasks and manage multiple projects effectively. This is largely a sedentary role; prolonged periods sitting at a desk and working on a computer. This would require the ability to lift files, open filing cabinets and bend or stand as necessary. Other Duties 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.

Job Description Position Summary The Principal Scientist will be responsible for leading innovation, driving clinical research, and ensuring the scientific integrity of the brand’s skincare portfolio. This role blends formulation science, clinical validation, regulatory compliance, and thought leadership, requiring collaboration with cross-functional teams such as Marketing, Sales, Education, Regulatory, and Quality. The ideal candidate will have a PhD (preferred) or PharmD or MS with 5-8 years of experience in medical-grade skincare, with expertise in cosmetic chemistry, clinical study design, claims substantiation, and scientific communication. Key Responsibilities 1. Innovation Leadership & Product Development • Lead major and minor launches, ensuring alignment with scientific credibility and brand innovation., • Research and integrate cutting-edge skincare technologies into new product formulations., • Collaborate with formulation chemists and CDMOs to optimize product development from concept to commercialization., • Reformulate products to meet global regulatory requirements and manage raw material discontinuations. 2. Clinical Research & Claims Substantiation • Design, execute, and interpret clinical studies to validate product efficacy and claims., • Identify and collaborate with clinical research organizations (CROs) and academic institutions for dermatology-based studies., • Write or review study protocols, informed consent forms, case report forms, and final reports., • Analyze clinical study data in collaboration with biostatisticians to ensure robust claims substantiation., • Publish at least two manuscripts or posters annually in peer-reviewed journals or dermatology conferences. 3. Scientific Communication & Thought Leadership • Train Key Opinion Leaders (KOLs), including physicians, nurse practitioners, aestheticians, and medical students, on scientific innovations., • Develop and deliver scientific training for the Sales and Marketing teams to strengthen internal technical expertise., • Present at industry conferences (e.g., dermatology, plastic surgery, aesthetics), • Conduct literature reviews on competitors’ products and train internal teams on scientific differentiation. 4. Regulatory & Compliance Collaboration • Partner with the Regulatory and Quality teams to ensure products meet domestic and international compliance requirements., • Review marketing claims (LCR process) for both new and existing products to ensure scientific accuracy and regulatory compliance. 5. Cross-Functional Collaboration & Business Support • Work closely with Marketing, Sales, Education, Quality, and Regulatory teams to ensure scientific rigor in product positioning., • Support new product launches by developing scientific messaging, claims support, and internal training materials., • Attend at least three industry conferences to stay ahead of skincare and dermatology trends., • Present product innovation updates and clinical results to executives as part of the stage-gate process., • Mentor junior RCD team members to foster a culture of scientific excellence and innovation., • Ability to handle and prioritize multiple projects/initiatives., • Celebrates successes and shares credit for work with others, • Expertise in cosmetic formulation, clinical research, ingredient evaluation, and regulatory compliance., • Strong publication record in skincare science and experience in peer-reviewed journals or dermatology conferences., • Some experience working with Key Opinion Leaders (KOLs) and clinical study sites to generate scientific data supporting skincare claims., • Excellent presentation skills, with experience training internal teams and external partners., • Experience with clinical trial design, including protocol development, statistical analysis, and claims substantiation., • Knowledge of global regulatory frameworks for skincare (e.g., FDA, EU, Asia-Pacific)., • Familiarity with intellectual property strategy and patent filings in skincare innovation. This role is ideal for an industry-leading skincare scientist who is passionate about bridging innovation, clinical research, and commercial strategy. As a Principal Scientist, you will shape the future of medical-grade skincare by ensuring scientific excellence, regulatory compliance, and thought leadership in the dermatology space. Leadership Competencies: • Initiates and drives changes related to marketed products, • Speaks up and has a point of view even when it is unpopular and can handle their own when challenged, • Knows when to get into the details and “roll up your sleeves” to help with tactics, • May supervise a professional staff, • Works cross organizations and with global partners Travel: • This position will require up to 30% of travel

Job Description Job Title: Technical Writer IV Location: Irving, TX – 100% Onsite Duration: 6 Months (Through 12/31/2025, with possible extension) Rate: $45 – $50/hr (W2) Interview Process: 2 Rounds (Phone/Video) Position Summary: We are seeking a highly detail-oriented Technical Writer IV with a strong background in the medical device industry. The ideal candidate will support the creation, editing, and management of technical documentation to ensure regulatory compliance and product testing standards are met. This role will play a critical part in developing and revising SOPs, forms, and procedures for internal teams and regulatory bodies. Key Responsibilities: * Develop, write, and maintain accurate and compliant documentation including procedures, forms, testing instructions, and regulatory materials. * Translate complex technical concepts into clear and user-friendly content for engineers, QA professionals, and technicians. * Collaborate with cross-functional teams including R&D, Quality, and Process Owners to gather and validate documentation requirements. * Ensure all documentation complies with internal standards and Good Documentation Practices (GDP). * Manage document revisions, version control, and archival processes. * Support CAPA-related documentation and participate in usability studies and risk assessments. * Assist in the creation of internal SOPs and training materials. Required Qualifications: * Minimum of 5+ years of technical writing experience in medical device, pharmaceutical, or FDA-regulated environments. * Proficiency with document management systems and Microsoft Office. * Strong working knowledge of medical terminology, regulatory writing standards, and FDA documentation requirements. * Excellent written and verbal communication skills. * Ability to manage multiple projects with tight deadlines. * Must have experience working in an onsite role in a regulated environment. Preferred Experience: * Background in medical device, pharma, or other FDA-regulated industries. * Experience with CAPA documentation and training SOPs. * Familiarity with ISO 13485 and other quality management systems. Education: * Bachelor's degree in English, Communications, Life Sciences, Engineering, or a related field. * Equivalent work experience may be considered in lieu of degree.

Job Title: Kitchen Document Control Specialist Reports to: Sr Kitchen Group General Manager FLSA Status: Exempt Note: This operation runs 24/7, and individual schedules are determined by volume and client needs. Weekend availability is required and the facility is only closed three days each year. Job Purpose: The Quality Assurance Supervisor is part of the Quality Assurance team. The Kitchen QA Supervisor will maintain and supervise Quality Assurance procedures in food manufacturing operations of Ready-to-Eat products. This role helps oversee applications of comprehensive quality and food safety programs and serves as the point of contact for regulatory inspections. Essential Duties and Responsibilities: • Develop, implement, and maintain the company’s document control system for policies, procedures, forms, SOPs, and work instructions., • Ensure documents are reviewed, approved, issued, and archived according to company and regulatory requirements., • Maintain version controls and prevent use of obsolete documents., • Track document changes and maintain revision histories., • Ensure documentation meets applicable standards (e.g., SQF, HACCP, FSMA, FDA, USDA)., • Support internal and external audits by retrieving, organizing, and presenting documentation., • Ensure proper retention and disposal of records according to legal and regulatory timelines., • Distribute controlled documents to relevant departments and ensure staff are trained on updates., • Assist in developing and maintaining document control training materials., • Communicate changes to procedures or policies in a timely and effective manner., • Maintain both physical and electronic filing systems for records, logs, and certificates., • Verify completeness and accuracy of production, quality, and food safety records., • Participate in system reviews to identify opportunities for process and efficiency improvements., • Recommend enhancements to document control procedures to meet evolving regulatory and operational needs., • Associate or bachelor’s degree in food science, Quality Assurance, Business Administration, or related field preferred., • 2–4 years of document control experience, preferably in a food manufacturing or regulated industry., • Knowledge of food industry regulations and certification programs (SQF, BRCGS, HACCP, FSMA)., • Strong attention to detail and organizational skills., • Proficiency in Microsoft Office Suite and document control software., • Assure that Minimum Vendor GMP and Food Safety Requirements are met., • Conduct internal audits of kitchen operations and maintain third-party audit preparedness., • Conduct timely investigations of all customer store complaints., • Strong computer skills required; proficiency in MS Office, Excel, and WMS systems., • SAP knowledge., • Must be able to interact with all levels of management and have excellent written and verbal communication skills., • Physical demands described are representative of those required to perform the essential functions of the job., • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ABOUT ACCURATE PERSONNEL Do you need your next job fast? Accurate Personnel is here to help! As an industry-leading full-service staffing agency, we have all the tools you need to start earning that next paycheck soon. Send us your application and our team will instantly get to work on finding you the right placement to fit your needs. Accurate Personnel has been a provider of temporary job services and direct hire search for 45 years. Our expertise has allowed us to grow from a regional Chicagoland office into a nationwide search firm that services over 500 clients while never losing sight of personalized service. Let Accurate work for you. Apply with us today! — Accurate Personnel provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Manager Trainee - Operations (Travel Program - Relocation Required) Position is based in a BioLife Center (not remote) Are you a self-motivated leader looking for a career that you can feel good about? At BioLife, opportunities to build a fast-paced career are within your reach. As a Manager Trainee, you will participate in a comprehensive training program aimed at enhancing your leadership skills, operational knowledge, and preparing you for accelerated career growth into an Assistant Manager role. Our centers are fast-paced, because that’s how we tackle rare diseases. With the incredible growth of 235+ BioLife Plasma Services centers across the U.S., the future looks bright for you. Opportunities to grow as a professional and as a leader are within your reach. When you work at BioLife, you’ll feel good knowing what you do makes an impact. A Typical Day for You May Include: • Assistant Manager Career Growth & Development: The development program lasts approximately 12 months and includes structured training with mentorship and leadership guidance. Upon completion, you’ll have an additional six months to advance into an Assistant Manager position., • Learn Operations Management: Over the course of the program, gain hands-on experience in operational production, including financial, regulatory, administrative, marketing, quality, facilities, and people management. Gain exposure to real-world challenges such as audit processes, compliance requirements, and team performance management., • Production Environment & Customer Service: Contribute to donor floor operations and ensure exceptional customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards., • Develop Leadership and Employee Relations Skills: Work alongside a diverse team and practice team member selection, performance feedback, and collaboration. Build foundational skills in mentoring, feedback delivery, and fostering an inclusive environment, preparing you for managing teams at various organizational levels., • Contribute to Creating Life-Changing Medicines: Learn how to maintain BioLife’s quality and safety standards to achieve production and cost goals while ensuring compliance with regulations and BioLife SOPs., • Networking (Travel) Opportunities: Embark on an exciting journey through our comprehensive travel package. You’ll explore BioLife locations nationwide, expanding your professional network and learning from our talented team members at various centers., • Relocation: Upon completing the program and earning a promotion to a management position, you will need to relocate to one of BioLife’s locations. Required Qualifications • Bachelor’s degree or equivalent leadership experience (approximately 3 years), • Willingness to travel up to 85% (program dependent), • Ability to relocate upon securing an Assistant Manager role through an application process, • Valid CPR/AED certification (or willingness to obtain during the program), • Ability to work a variety of shifts, including evenings, weekends, and holidays, • Ability to walk and/or stand for the entire work shift, • Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees, • Ability to frequently lift up to 32 lbs. and occasionally up to 50 lbs., • Fine motor coordination, depth perception, and ability to monitor equipment from a distance, • Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear Preferred Qualifications • Familiarity with SOPs, GDP, GMP, CLIA, and FDA regulations, • Experience working in a regulated industry or high-compliance environment We Offer Comprehensive Benefits from Day One • Major medical, dental, and vision insurance and prescription coverage for eligible employees, • A minimum of 15 vacation days and 10 company-paid holidays, • Tuition reimbursement, • Retirement savings with a generous employer contribution and matching program, • Short- and long-term disability insurance, • Life and AD&D insurance About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity BioLife is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, veteran status, or other protected characteristics. #LI-Remote #LI-JT1 #ManagerTrainee #MT-HTF BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Texas - Virtual U.S. Base Salary Range: $52,800.00 - $72,600.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsTexas - VirtualUSA - TX - Irving Worker TypeEmployee Worker Sub-TypeRegular Time TypeFull time Job Exempt Yes

Fort Worth-based medical device manufacturer and creator of PolyMem Advanced Wound Care Dressings, is seeking a Regulatory Specialist to support the Regulatory Development team. This role involves preparing regulatory submissions, supporting audits, monitoring regulatory changes, and collaborating w

You will dive head-first into FDIC Part 370 regulatory compliance while also focused on modernizing our critical systems and lead development for platform functionality that calculates firm wide deposit insurance as prescribed by FDIC Part 370. Lead a team of 4+ Product Managers engaged in the FDIC

Advanced knowledge of regulatory compliance, relevant industry regulations and regulatory data sources. Maintains and promotes awareness of relevant regulatory requirements, industry enforcement actions, and regulatory changes. The Senior Advisor serves as a subject matter expert to ensure documents

At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, youll be recognized for your commitment and contributions and see your career like never before.Together, we go above a

This position is a full-time in office role located in Dallas, TX and is in-eligible for relocation assistance.By submitting your application you are acknowledging that you understand the in-office requirement in Dallas, TX.The Revenue Cycle Director Management will oversee and optimize the end-to-e

At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, you’ll be recognized for your commitment and contributions and see your career like never before.Together, we go abov

This position is a full-time in-office role located in Dallas, TX, and is ineligible for relocation assistance.By submitting your application, you are acknowledging that you understand the in-office requirement in Dallas, TX.Director, Revenue Cycle Management (Healthcare).This leader will be respons

An international health system is looking for a Healthcare Regulatory Counsel to support their legal team. The Healthcare Regulatory Counsel will be responsible for:. Delivering timely and accurate regulatory compliance guidance connected to clinical operations and activities.

What you’ll need to succeed as a Specialist, AR Corrections at XPO Minimum qualifications: High School Diploma or equivalent 1 year of experience in accounting, invoicing or freight audit, OTC, accounts receivable or accounts payable Excellent time management skills with a proven ability to meet d

In this high-impact role, youll design and facilitate training programs for NOC teams (including Air Traffic Management, Meteorology, and Customer Planning), develop operational procedures, and maintain regulatory compliance all while working cross-functionally within one of the most vital parts of

If you are interested in the Healthcare Regulatory Counsel role, then please don't wait to apply. An international health system is looking for a Healthcare Regulatory Counsel to support their legal team. The Healthcare Regulatory Counsel will be responsible for:.

Fort Worth-based medical device manufacturer and creator of PolyMem Advanced Wound Care Dressings, is seeking a Regulatory Specialist to support the Regulatory Development team. This role involves preparing regulatory submissions, supporting audits, monitoring regulatory changes, and collaborating w

Director, Global Transaction Tax (Federal).Director, Global Transaction Tax (Federal).A&M is a group of entrepreneurial, action and results-oriented professionals who take a hands-on approach to solving our clients' problems and assisting them in reaching their potential.Our culture celebrates i

JOB DESCRIPTION Job Summary Molina Healthcare Services (HCS) works with members, providers and multidisciplinary team members to assess, facilitate, plan and coordinate an integrated delivery of care across the continuum, including behavioral health and long-term care, for members with high need pot

Risk Operations Strategy & Transformation-Center of Excellence (CoE).Country: United States of America.Santander is a global leader and innovator in the financial services industry.We believe that our employees are our greatest asset.Our focus is on fostering an enriching journey that empowers you t

We’re looking for bold, entrepreneurial talent ready to help build something extraordinary — and reshape the future of building products distribution.QXO is a publicly traded company founded by Brad Jacobs with the goal of building the market-leading company in the building products distribution

Stays current with industry and regulatory trends and emerging risk issue; maintains good understanding of current market and competitive landscape.

JOB DESCRIPTION Job Summary Provides support for clinical member services review assessment processes.Responsible for verifying that services are medically necessary and align with established clinical guidelines, insurance policies, and regulations - ensuring members reach desired outcomes through

NextGen Applications Analyst Regulatory Upgrade. NextGen 8 regulatory upgrade rollouts. Ensure compliance with regulatory, security, and infrastructure standards.

We are hiring for a full-time Physical Therapist in the Cleburne / Burleson area.At DFW Home Health, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the communitie

NextGen Applications Analyst – Regulatory Upgrade. NextGen 8 regulatory upgrade rollouts. Ensure compliance with regulatory, security, and infrastructure standards.

At Alcon, we are driven by the meaningful work we do to help people see brilliantly.We innovate boldly, champion progress, and act with speed as the global leader in eye care.Here, youll be recognized for your commitment and contributions and see your career like never before.Together, we go above a

Description At CDW, we make it happen, together.Trust, connection, and commitment are at the heart of how we work together to deliver for our customers.It s why we re coworkers, not just employees.Coworkers who genuinely believe in supporting our customers and one another.We collectively forge our p

Experience the HCA Healthcare difference where colleagues are trusted, valued members of our healthcare team.Grow your career with an organization committed to delivering respectful, compassionate care, and where the unique and intrinsic worth of each individual is recognized.Submit your application

Full Time Day Shift Position, Monday - Friday, 10-hr.Hours are from 6:30am - 5:00pm.NO CALL REQUIRED for this position.May Be Eligible for a Sign On Bonus of $20K.Experience the HCA Healthcare difference where colleagues are trusted, valued members of our healthcare team.Grow your career with an or

Make an impact in the role of Coca-Cola Quality Control Technician to follow safety procedures and company policies, provide excellent service to customers and team members, and gain knowledge of company offerings to better serve clients.Other duties include assist with processing returns and exchan

JOB DESCRIPTION Job SummaryProvides support for clinical member services review assessment processes.Responsible for verifying that services are medically necessary and align with established clinical guidelines, insurance policies, and regulations - ensuring members reach desired outcomes through i

RELOCATE TO VIRGINIA OPPORTUNITY.Join our esteemed team of healthcare professionals committed to advancing healthcare through cutting-edge research, comprehensive training, and compassionate care.UVA Health is an integrated health system with a world-class academic medical center that includes a lev

Reporting to the Manager of Clinical Informatics for Analytics & Interfaces, the Associate Clinical Informatics Analyst is responsible for supporting application, hardware and software technical support for the Care Connections and Clinical Informatics teams.Assists in the hardware and software supp

QA Analyst Remote Job Duties: • Partner with the product and engineering team to understand project objectives, gather requirements, troubleshoot issues, and implement scalable test solutions • Design

SporTherapy has invested in my personal and professional growth tremendously through leadership, management, and fellowship training.I have been given opportunities that I would not have had otherwise.The investment in its employees and company culture.BRANDON O’MALLEY, PT, DPT, OCS, FAAOMPT.How C

Support responses to regulatory and Bank-partner inquiries, audits, and examinations through second – line advisory, review, and oversight to ensure compliance with regulatory requirements. Provide guidance to AFF’s Business and Operations teams on applicable regulatory requirements and recommen

Regulatory Compliance and Industry Standards: Stay up to date with evolving healthcare regulations, pharmacy industry standards, and payer requirements to ensure compliance in all pharmacy-related processes. Experience with pharmacy reimbursement models, pharmacy compliance, and healthcare reg

The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). Provide r

The Director of Regulatory Affairs provides regulatory compliance leadership to the Company's Product Safety Team for animal and pet food products. Promotes maintenance and application of changing regulations, regulatory standards and protocols. Serves as a resource to facility management during and

Minimum of 2 years of regulatory affairs experience with strong knowledge of FDA and USDA food regulations. As part of the fast-paced and driven PepsiCo Regulatory Affairs team, you will be responsible for ensuring faultless compliance of ingredients and system documentation for several brands withi