Fda jobs in Cherry Hill, New Jersey - Page 2Crear alertas

Purpose The Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies/strategies in alignment with all regulatory authorities/guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements. Key Accountabilities: • Ensure adherence to batch records and aseptic techniques., • Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique., • Conduct Investigations for manufacturing deviations., • Execute CAPAs & Change Controls., • Provide Aseptic Training, • Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations., • Keep abreast of relevant guidance documents pertaining to 503B production., • Monitor and communicate changes in regulations of all state and federal regulatory agencies., • Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations., • Attain all non-resident Pharmacist licenses within 1 year. Primary Accountabilities: • Assist the Associate Director of Compounding Operations ,daily oversight of compounding personnel and compounding operations in cleanroom environments. . Review, prepare and approve manufacturing deviations, master batch records and site change controls related to 503B Compounding Operations., • Participate in the administration of Site Projects and New Product Launches to support 503B operations., • Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments., • Provide technical support in the interactions with and applications to state and federal regulatory bodies., • Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy., • Assist in writing, review and update of batch records, SOPs, and other cGMP documents., • Maintain current pharmacist licenses in required states, as directed., • Other duties as assigned. Qualifications: Minimum: • Bachelor of Pharmacy or PharmD required., • State of New Jersey license as a pharmacist is required. Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA)., • 503B Compounding experience and/or USP 797 knowledge and experience required., • Knowledge of sterile compounding practices., • Knowledge of associated standards and operating procedures in relation to cGMP., • Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.), • A broad perspective to organize objectives, both long-term and day-to-day activities Experience: Minimum: • Pharmacist for a 503B outsourcing facility located in New Jersey preferred, • New Jersey licensure is required, as well as the ability to obtain multiple state licenses., • Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage. Skills: • The ability to change direction and focus to meet shifting organizational and business demands., • The ability to create and contribute to an environment that values people encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition., • The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals., • The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity., • The ability to manage multiple resources and be accurate and current with data and information., • Ability to communicate technical information to non-technical personnel What We Offer • Clean climate-controlled working environment, • Annual performance bonus potential, • 401k employer match up to 6% of your contributions, • 23 vacation/personal days, • 11 paid Company holidays, • Generous healthcare benefits, • Employee discount program, • Wellbeing rewards programs, • Safety and Quality is a top organizational priority, • Career advancement/growth opportunities, • Tuition Reimbursement, • Maternity and Parental Leave *Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or prog

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary Of Objective The main responsibilities of the Sr. Director – NPI Engineering is focused on the planning and execution of projects from estimating to launch: • Manage and communicate the site portfolio of NPI projects, ensuring projects are managed to intended capital and resource cost and scope, • Provide resources and oversight to project estimating activities to develop a trusted project resource plan, • Own the resource planning process for the NPI engineering team, coordinated with other functional leaders (quality, validation, facilities, etc.) providing resources to project teams., • Provide support to project teams, taking on risk mitigations, issue resolution, and escalations to ensure on-time launches at target quality and unit cost, • Leading change and continuous improvement activities for the NPI process, • Oversees NPI engineering project management., • Supervises a staff of engineers and/or engineering technicians and provides guidance, leadership, and mentorship in areas of engineering, project management, and professional development., • Prioritizes and guides engineering and project management resources in the design of new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to business plan., • Plan and manage capital plan for facility and production equipment related spending to assure production can meet new product development, equipment commissioning, product launch, and contract packaging requirements., • Works with global engineering to guide the specification and selection of manufacturing equipment/utility equipment and awards architectural and engineering contracts based on competitive bids and analysis developed by site Project Managers., • Adapts NPI engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring., • Communicates significant equipment or process issues to site leadership., • Measure and analyze performance metrics of the NPI project portfolio, and undertake escalations to address time, cost and scope issues., • Ensure effective communication, planning and coordination between other functions, • Prepares equipment/engineering estimates for potential projects (to be submitted to sales)., • Analyzes sales requests to determine equipment, tooling, or delivery systems needed., • Oversee the Engineering review of all components for new jobs (size, capability of equipment, bar codes)., • Conducts and/or participates in customer meetings and attends occasional off-site meetings., • Participates in internal review meetings to plan new jobs with plant Operations, Maintenance, Quality, Purchasing and Process Engineering., • Responsible for the administration, implementation, and project management of assigned projects, including using company-wide standardized methodology., • Coordination of outside design, integration, and equipment manufacturing services., • Manages the site facilities and utilities to accommodate new equipment and meet all regulatory requirements., • This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Required • Bachelor's Degree in Engineering or related field, • 7-10 years experience in a related industry, • College Level Mathematical Skills, • Program and Project management, • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs., • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs., • High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms., • Ability to adapt to changing work environments., • Ability to effectively present information to various people as the job requires., • Ability to work independently and/or as part of a team., • Ability to display excellent time management skills., • Lean/Six Sigma training Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

POSITION SUMMARY: The Regulatory Compliance Specialist is responsible for creation, evaluation, and approval of finished product information. The candidate ensures information complies with all applicable domestic or international regulations and customer requirements. Information includes but is not limited to product labels, product specifications, certification documents, export paperwork, and regulatory letters. The Regulatory Compliance Specialist is responsible for researching and reporting applicable regulations to ensure finished product labeling compliance and to help resolve complex questions or problems. The candidate will actively apply knowledge of regulations to assist in internal product development, marketing, operational, and purchasing decisions. The candidate will also help the Regulatory Compliance Manager continually develop and improve internal procedures and processes. ESSENTIAL FUNCTIONS: • Verifies label content and provides approval on all finished product labels by applying a thorough knowledge of federal, state, local, and international food labeling requirements., • Aids management in risk evaluation/mitigation efforts related to product labeling, claim verification, and allergen assessments., • Completes and reviews all records or calculations which include but is not limited to creditable juice percentage, added sugars, nutrient content claims, issue resolution/findings, and creditable protein/grains., • Create labels that comply with applicable international requirements., • Aids with the completion of all customers requested documentation and required domestic/international documentation., • Identifies, interprets, and reports relevant regulations to ensure regulatory compliance and to minimize risks by applying working knowledge of domestic and international food laws., • Participate in cross functional meetings that support product innovation and change., • Aids with reporting and evaluation of ingredient compliance initiatives., • Researches and provides information to aid in addressing customer's technical questions about finished products, when related to labeling or documentation., • Resolves complex problems by applying extensive technical knowledge and experience., • Maintains accurate and complete records, in compliance with applicable recording keeping requirements, to ensure product traceability and data integrity., • Effectively communicates technical and regulatory data and recommendations by appropriately tailoring content and approach to the intended audience., • Monitors industry relevant publications for insight on potential risks, regulatory changes or trends and communicates findings to team management., • Works with internal departments, customers, vendors, and team members to successfully accomplish tasks., • Responds to urgent business needs with accuracy, completeness, and professionalism., • Assists the Regulatory Compliance Manager with internal compliance training initiatives. COMPETENCIES: • Possess ability to interpret and apply federal, local, state, and international food laws and regulations., • Working knowledge of FDA, USDA, and international labeling requirements., • Have a strong knowledge of domestic and international food regulations and the governing bodies endorsing them., • Capable of quickly researching, interpreting, and applying regulations to specific topics., • Display a strong understanding of identity preserved certification requirements., • Capable of working with multiple departments simultaneously to achieve a variety of goals., • Be detail-oriented, organized, efficient and resourceful with strong problem-solving skills., • Be able to demonstrate business acumen through issue identification, risk management, and cross-functional consensus building., • Must exhibit a high degree of adaptability to engage effectively with all levels and styles of employees and management., • Self-motivated, can operate autonomously while working collaboratively with other cross-functional team members as part of an interdisciplinary team., • Capable of managing simultaneous workloads, multiple customer demands and shifting priorities within a fast-paced, rapidly evolving environment with the ability to multi-task, prioritize, and adapt well to change., • Must demonstrate excellent communication (written and verbal) and interpersonal skills., • Can handle complexity and judgment to meet business needs., • Capable of taking an independent initiative; and achieve results to benefit the department and company., • Have a respectable professional persona and act as a representative for the department., • Excellent organization and time management skills., • Must complete all the above and any other duties as assigned by management., • Proficient in all Office Programs: Excel, PPT and Word. EDUCATION AND EXPERIENCE • Bachelor’s degree in Nutrition, Food Science, Food Safety, or related field., • Minimum 2 years’ labeling experience in the food industry., • Must have knowledge of federal, local, state, & international food regulations., • Experience with Genesis R&D required., • Experience working successfully within a time-sensitive, process-driven environment TRAVEL REQUIREMENTS: • May travel to other plant sites on occasion. Disclaimer: This position description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the team member. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. EEO Statement: J&J Snack Foods Corp.is an equal opportunity employer and prohibits discriminatory employment actions against, and treatment of, employees and applicants for employment based on actual or perceived Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, alienage, religion or creed, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status, sex offenses, prior record of arrest or conviction, genetic information or predisposing genetic characteristic, status as a victim or witness of domestic violence, sex offenses or stalking and unemployment status.

The Sanitation Supervisor is extremely important and critical to the production of food products. Leading and training all sanitation employees in the cleanliness of the facility. You must have the ability to work in a fast pace environment, under pressure and follow verbal and written directives. Train and motivate new and seasoned employees. Execute all sanitation and production schedules. Comprehend all SSOP and be flexible and willing to adapt and improvise to accommodate schedule changes in sanitation as well as production. RESPONSIBILITIES: • Maintain an environment that assures a high level of employee and food safety, • Supervise, schedule, coach, train, lead and motivate a shift of sanitation workers to meet planned objectives, • Prepare for regulatory and customer inspections, • Cooperate with engineering and production departments in the required sanitation of equipment and facilities, • Collaborate to improve performance as measured by waste, downtime, and efficiency, • Operate to pre-set Quality and Sanitation standards; improve standards and implement them where they do not exist, • Maintain proper morale and teamwork within the department, • Control inventory (sanitation supplies and chemicals), • Trouble-shoot problems, • Cross-train employees, • Conduct employee performance evaluations, • Maintain union relations, • Coordinate with Receiving, Production, Shipping, and Maintenance departments, • The ability to clean and sanitize all equipment in this facility as well as learn to clean any new equipment., • Need to be able to use all equipment that pertains to sanitation., • Need to be able to comprehend and execute Lock Out/Tag Out (LO/TO)., • The ability to dispense chemicals at the approximate titration. QUALIFICATIONS: • 2-3 years proven work experience in manufacturing, production or industrial setting, • Aptitude in production processing and Food Safety, • Experience and/or education in Food Safety, • Leadership skills, • Work independently, positive work attitude, self-starter, dedicated, detail oriented & professional demeanor, • Ability to work all shifts and weekends (required), • Knowledge/experience in FDA, USDA, and food plant operations, • Knowledge/experience in pest control in a food plant environment, • Working knowledge of Microsoft Office products (Word, Excel, PowerPoint), • Excellent verbal and written communication skills in English ADDITIONAL ATTRIBUTES: The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. The incumbent is subject to manufacturing, warehouse, and distribution environments which include proximity to moving parts and exposure to heat, odors, and noise. The position requires the employee to stand, walk, sit, reach above shoulder level, climb or balance, stoop, kneel, and crouch. The employee must occasionally lift up to 50 pounds. The position requires flexibility regarding start-times and the number of hours to be worked daily (this is not a "9 to 5" job). Work can include weekend hours as the needs of business dictate. WORK ENVIRONMENT: • Work in a noisy environment, • Work indoors as well as outdoors, • Work in wet and/or humid conditions, • Work in cold or hot environments, • Work around machinery

Job DescriptionDescription: SUMMARY The Regulatory Compliance Technician provides administrative and regulatory support to ensure Medwiz Pharmacy’s compliance with federal and state pharmacy laws, DEA regulations, CMS requirements, and PBM standards. This position assists with maintaining pharmacy and staff licenses, tracking compliance documentation, preparing for audits and inspections, and supporting daily functions of the Compliance Department. The role requires strong organizational skills, attention to detail, and the ability to manage multiple regulatory processes across multiple states. ESSENTIAL FUNCTIONS • Assist in maintaining compliance with all applicable federal and state pharmacy regulations, including DEA, FDA, CMS, and Board of Pharmacy requirements., • Assist in preparing documentation for DEA and Board of Pharmacy reporting (e.g., theft/loss, inventory discrepancies)., • Maintain organized, audit ready documentation and ensure corrective actions are tracked and completed, • Support collection and verification of date for compliance reports, audits, and policy reviews, • Assist in preparing the pharmacy for audits, inspections, and credentialing reviews by regulatory agencies, PBM’s, and accrediting bodies, • Maintain compliance department’s documentation system including annual trainings, licenses, and personnel, • Track employee policy acknowledgements and compliance training completion records Requirements: QUALIFICATIONS • High School Diploma or GED required, • Associate’s in Healthcare, Business Administration, or related field preferred, • 1-2 years of experience in pharmacy, healthcare compliance, or regulatory administration, • Knowledge of DEA, FDA, CMS, and Board of Pharmacy regulations preferred., • Strong organizational and multitasking abilities with exceptional attention to detail, • Proficiency in Microsoft Office Suite (Word, Excel, Outlook, Teams), • Strong written and verbal communication skills, • Ability to maintain confidentiality and handle sensitive information with professionalism

Job Description Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title GMP Warehouse Associate FLSA Status Non-exempt Salary Starting at $18/hour based on experience plus twice a year bonuses Summary This position requires an individual who can work within a cGMP environment in collaboration with members of the warehouse and cross-functional teams under the direct supervision of the Manufacturing Manager. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Maintain clear and traceable records of all physical and system transactions to enable quick identification and management of all material movements., • Receive incoming shipments of non-GMP/GMP materials and equipment following established procedures., • Ensure the appropriate documentation is reviewed and matches each item received or shipped., • Inspect all incoming and outbound materials for damage, proper seals and protection as part of acceptance criteria., • Assist Quality Assurance in the disposition of materials to include application of status indicators and material movement and storage in the appropriate designated areas of the warehouse to prevent cross-contamination and mix-ups., • Prepare and dispense GMP materials to support production operations., • Ensure proper procedures and conditions are followed during the transport and delivery of raw materials, samples and finished products., • Maintain accurate physical and system (ERP) transactional inventory of GMP warehouse materials., • Support procurement team and activities as required., • Perform routine inventory cycle counts., • Ability to cross-train in all areas of the warehouse operations to include applicable GMP, GDP, EPA, DEA, DOT and OSHA training or certifications., • Pick, pack, and ship finished product, materials, and equipment as required per established policies and procedures., • Adhere to all safety procedures and GMP requirements., • Actively participate in Safety programs, Quality inspections and Warehouse audits., • Keep the warehouse clean, neat, orderly and inspection ready. Must apply and adhere to Good Housekeeping Practices in a GMP environment. Required Education and Experience • Minimum high school diploma or general education degree (GED), • Experience with inventory management (ERP) and/or (LIMS) software is required, • Prior experience working in a GMP compliant warehouse setting is a requirement, • Must have knowledge of 21 CFR Part 210 and 211 for cGMP operations, • Must have prior experience with donning PPE, • Must be able to work independently as well as collaborate with teams, • Must possess strong verbal, written and oral communication skills, • Must exhibit punctuality and low absenteeism, • Occasionally lift to 50 lbs., routinely lifts to 25 lbs. Competencies • Detail Oriented, • Communication, • Organizational Skills, • Technical Capacity, • Problem Solving/Analysis Supervisory Responsibility This position has no supervisory responsibilities. Work Environment This job operates in a controlled laboratory environment and in a warehouse setting. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Occasionally lift up to 50 lbs., routinely lifts up to 25 lbs., • This position is moderately active and requires standing and walking for a majority of the shift Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.

AD GHEOR & RWE Location: Remote EPM Scientific is partnered with a rapidly growing, Commercial-Stage Biopharmaceutical company to hire an Associate Director of Global HEOR and Real-World Evidence. Our client is seeking to add an agile, collaborative RWE expert to focus on executing functional objectives and contribute to some strategic direction to help the organization continue to make a massive impact in the lives of MASH patients. If you thrive in a fast-paced environment and want to join a growing organization that truly values scientific excellence this could be a great fit. Responsibilities: • Analyze real world data sources like EHR and administrative claims, • Develop RWE platforms utilizing R programming, • Present at conferences and continue to publish in relevant journals, • Collaborate with global stakeholders across the HEOR team, regulatory, market access, biostatistics, etc., • Ensure observational studies are FDA & EMA regulatory compliant to support label expansions and HTA submissions Qualifications: • Graduate degree in biostatistics, epidemiology, public health, or similar field, • 10+ years of relevant experience in evidence generation and execution of observational studies, • Previous consulting experience, current industry experience in a real-world evidence role, • Strong communication skills, • Deep R programming experience, expert in advanced statistical analytic methodologies, • Track record of producing high quality real world evidence to support HTA submissions, • Therapeutic area experience: liver/ metabolic disease preferred Please Note: This position does not offer visa sponsorship. Candidates must be authorized to work in the United States without the need for current or future sponsorship. **Applicants who do not meet the above requirements will not be considered for this role. Desired Skills and Experience Graduate degree in biostatistics, epidemiology, public health, or similar field 10+ years of relevant experience in evidence generation and execution of observational studies Previous consulting experience, current industry experience in a real-world evidence role Strong communication skills Deep R programming experience, expert in advanced statistical analytic methodologies Track record of producing evidence to support HTA submissions Therapeutic area experience: liver/ metabolic disease preferred

Production Supervisor – Permanent Role (Pennsauken, NJ) Schedule: Mon–Thu 7:00 AM–4:00 PM | Fri 7:00 AM–2:00 PM (Paid 30-min lunch) Overview: Seeking an experienced Production Supervisor to lead daily manufacturing operations in cleanroom and controlled environments. This role oversees a team of 12–18 technicians while ensuring compliance, efficiency, and production excellence. Key Responsibilities: • Supervise day-to-day production in cGMP cleanrooms., • Lead, coach, and schedule production and aseptic processing teams., • Ensure compliance with cGMP, SOPs, batch records, and safety standards., • Review/approve batch records and collaborate with QA, QC, Engineering, and Leadership., • Investigate deviations and implement CAPAs., • Support validations, equipment qualifications, and audits., • Maintain material inventory and drive continuous improvement., • Provide leadership, problem-solve operational challenges, and promote a compliance-first culture. Qualifications: • Bachelor’s in Pharmaceutical Sciences, Chemistry, Engineering, or related field., • 3–5 years pharmaceutical production experience; 1+ year supervisory (3+ preferred)., • Strong knowledge of cGMP and FDA/ICH guidelines., • Experience with EBR systems a plus., • Proven ability to lead teams, manage shifting priorities, and maintain quality focus., • Ability to work extended hours as needed.

Job Description Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title Customer Care Professional FLSA Status Non-exempt Salary Starting at $16/hour based on experience plus twice a year bonuses Reports To Pharmacist/Customer Care Professional Lead Job Summary This position requires an individual who has the experience and ability to handle high call volume in an active call center environment. The qualified candidate ensures the customer receives the best service possible while demonstrating enthusiasm, diligence and resilience. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Answer incoming calls from customers and make outbound calls to process orders received from doctor offices, • Manage and resolve customer complaints with a sense of concern and urgency, • Enter new customer information into the appropriate system and update existing customer information, • Document all call information according to standard operating procedures, • Deliver superior customer service with a friendly demeanor, can-do attitude and willingness to help at all times, • Maintain a position of trust and responsibility by keeping customer information confidential, • Demonstrate sound decision making according to established guidelines/procedures, • Continuously increase job knowledge and skills through self-motivation and in-house training Required Education and Experience • High school diploma or general education degree (GED), • Customer service call center experience preferred but not required, • Must possess strong verbal, written and oral communication skills, • Must have basic to moderate computer skills and have the ability to learn new software programs quickly, • Must exhibit punctuality and low absenteeism, • PTCB Certification a plus, • NJ Pharmacy Technician License is not required but is a plus, • May sit, stand, stoop, bend and walk intermittently during the day. May sit or stand seven (7) to ten (10) hours per day, • May be necessary to work extended hours as needed, • Finger dexterity to operate office equipment required Eligibility Qualifications It may be necessary to work extended hours as needed. Competencies • Communication Skills, • Customer/Client Focus, • Organizational Skills, • Problem Solving/Analysis, • Technical Capacity Work Environment This job operates primarily in an office environment. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • May sit, stand, stoop, bend and walk intermittently during the day., • May sit or stand seven (7) to ten (10) hours per day., • Finger dexterity to operate office equipment required., • May need to lift up to twenty-five (25) pounds on occasion Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.

Job Description Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality. Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Work Schedule Monday - Thursday, 2:00 pm to Midnight FLSA Status Non-exempt Salary Starting at $20/hour based on experience plus twice a year bonuses Summary A Pharmaceutical Cleaner Sanitizer plays a crucial role in maintaining the highly controlled environments required for pharmaceutical manufacturing. The Cleaner Sanitizer is responsible for maintaining a meticulously clean and sterile environment within the manufacturing areas, ensuring compliance with strict regulations and contributing to product quality and safety. This involves properly following detailed cleaning procedures and protocols to minimize contamination risks. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Must be able to aseptic gown, demonstrate aseptic technique and pass annual gown qualifications., • Perform routine cleaning and sanitization of rooms, surfaces, equipment, and tools within designated areas such as clean rooms, storage areas, controlled environments and other manufacturing processing areas., • Follow established protocols and standard operating procedures (SOPs) for cleaning and sanitization., • Ensure compliance with Good Manufacturing Practices (GMPs) and ISO standards., • Maintain accurate records of cleaning times, chemicals used, and other relevant data, practicing Good Documentation Practices (GDocPs). Ensure all documentation completed is Attributable, Legible, Contemporaneous, Original, and Accurate in accordance with ALCOA principles and GDocPs., • Empty trash, manage waste receptacles, and handle hazardous or biohazard materials appropriately., • Assist in setting up manufacturing operations as needed., • Disassemble, clean, sanitize, and reassemble processing equipment as needed., • All equipment should be set up and operated in a proper manner. Any wear or damage to equipment or parts should be immediately escalated to management prior to using the equipment., • Must have or gain a basic understanding of room environments and parameters, such as temperature and humidity, escalate any events outside standards to supervision., • Document all cleaning activities, observations, and deviations from SOPs as required by policies and procedures., • Adhere to all sanitation procedures and regulatory requirements (e.g., FDA)., • Wear appropriate Personal Protective Equipment (PPE) as required., • Properly and carefully follow procedures for cleaning up spills and other contamination events., • Handle cleaning chemicals safely, including understanding dilution and usage procedures., • Troubleshoot and resolve operational issues related to clean room activities., • Monitor and replenish inventory of cleaning supplies and chemicals as needed., • Responsibilities include exhibiting training competency while performing all required cleaning, sanitizing and support tasks., • May be involved in training new employees on clean room procedures., • Potentially assist in other areas such as supporting manufacturing operations or coordinating with other teams., • May need to move materials and equipment to access and clean designated areas. Other Duties and Responsibilities • Daily activities and assigned tasks should always be performed in a safe and efficient manner., • All unusual, non-routine occurrences when performing tasks (NOE report) should be immediately reported and escalated to management., • May be asked to assist in the development or revisions of Standard Operating Procedures (SOP), master batch records or other relevant cGMP documentation., • Adhere to all company dress code attire, jewelry policy and proper protective equipment (PPE) requirements. Maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas), • Attend training classes, workshops, meetings, etc., as required to contribute as a subject matter expert (SME) for investigations, remediation, process optimization or improve job skills., • Actively participate in shift changeover, handoff sessions when and where applicable., • May be asked to participate in other Manufacturing Operations not listed on a need basis. Required Education and Experience • Highly regulated GMP cleaning requires a high degree of attention to detail to ensure all areas are thoroughly cleaned and sanitized., • Prior cleaning and sanitizing experience in a heavily regulated environment such as the pharmaceutical industry is preferred., • Prior training and knowledge of GMP / GDocP is preferred. Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations, • Minimum high school diploma or general education degree (GED), • Must be willing and able to work in controlled environments with both small and large machinery, • Must possess strong verbal, written, and oral communication skills, • Must be able to work independently and with a team, • Ability to recognize priorities and actively make productive use of time to build operational efficiencies, • Must exhibit punctuality and low absenteeism Competencies • Detail Oriented, • Meticulous, • Communication, • Organizational Skills, • Problem Solving/Analysis, • Results Driven, • Technical Capacity Supervisory Responsibility This position has no supervisory responsibilities. Work Environment This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Able to stand, walk, sit, bend or reach, 8-10 hours or more per day as needed, • May need to lift or maneuver up to 50 pounds on occasion Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.

Job DescriptionCAI Overview:Are You Ready?CAI is a 100% employee-owned professional services company established in 1996 that has grown to over 700 people worldwide. We provide program and project management, commissioning, qualification, validation, start-up, and other consulting services associated with operational readiness and operational excellence to FDA-regulated and other mission-critical industries.We put our clients’ interests first, we do not stop until it is right, and we will do whatever it takes to get there.At CAI, we are committed to living our Foundational Principles:We act with integrityWe serve each otherWe serve societyWe work for our futureWe believe that with employee ownership, one person’s success is everyone’s success. We embrace a Team Before Self mindset, demonstrate Respect for Others, and maintain a Can-Do Attitude—our three core values. Position Overview:The Operational Readiness Project Manager (ORPM) serves as a strategic leader bridging the gap between mechanical completion and sustained operational performance. The ORPM designs and leads holistic Operational Readiness programs using CAI’s six-pillar Readiness Framework. This role ensures project teams achieve right-first-time metrics, foster a culture of continuous improvement, and deliver world-class performance from day one. Key Responsibilities:1. Project & Program Leadership- Lead project teams to achieve Operational Readiness (OR) objectives.- Manage readiness-to-operations lifecycle for 1–3 client engagements simultaneously.- Drive on-time, on-scope delivery of readiness programs. 2. Pillar Integration & Execution- Serve as the primary consultant for OR campaigns integrating with Quality, Process, and Workforce streams.- Apply OE principles to pre-Day One activities (e.g., visual management, accountability, problem-solving). 3. Client Advisory- Act as a trusted advisor to executive stakeholders (VPs, Site Heads, etc.).- Guide decision-making with a risk-based, speed-to-value mindset. 4. People Development- Lead and coach cross-functional teams including CQV, Quality, and external contractors.- Cultivate a culture of feedback and growth. 5. Thought Leadership-Contribute to CAI's brand via white papers, conference presentations, and client tools. Skills & Characteristics Required:- Consulting & Facilitation- Align project stakeholders with clear vision and measurable goals.- Expert-level guidance for site and department leadership.- Project Execution- Manage scheduling, resource loading, controls, and closeout.- Execute comprehensive project planning and delivery.- Continuous Improvement- Drive site-wide transformation using Lean, Six Sigma, or TPM methodologies. Qualifications and Experience:- BS or MS in a relevant science or engineering field (or equivalent).- 3+ years as a program/project manager on life science projects ($1MM+), or- 8+ years in GMP-regulated operations with 5+ years leading readiness/start-up/OE transformations. (Black Belt or equivalent preferred.)- Proven multi-site or multi-client portfolio experience.- Deep understanding of quality systems, tech transfer, equipment qualification, and analytics.- Excellent communication, leadership, and stakeholder management skills.- Proficient in project management software tools. Other Requirements:- Excellent written and verbal English communication.- Able to work in the U.S. without sponsorship now or in the future.- Domestic and international travel may be required.- Willing to work overtime when necessary.- PMI PMP or PgMP certification a plus. Critical CompetenciesInfluence Strategy - Evaluates and pursues initiatives, opportunities, and priorities based on fit with organization strategies.- Identifies innovative solutions to challenges that have strategic impact, balancing both short- and long-term concerns.- Identifies issues related to emerging customer and market needs. Satisfy the Customer - Identifies and anticipates customer requirements, expectations, and needs.- Develops solutions that meet or exceed customer expectations and shares feedback with relevant groups.- Consistently follows up with customers to resolve issues and maintain customer satisfaction and loyalty.- Continually searches for ways to improve customer service, including removal of barriers and providing solutions. Plan for Success - Translates business/function strategies into aligned plans and objectives and integrates across business groups.- Obtains and allocates resources needed to accomplish goals.- Anticipates risk and builds effective contingency plans. Pursue Execution - Prioritizes and balances time, actions, resources, and initiatives to ensure achievement of critical goals.- Holds self and others accountable for achieving outcomes. - Anticipates obstacles and takes appropriate actions to accelerate work or improve quality. Tailor Communication- Communicates information clearly, concisely, and professionally.- Tailors communication style and content to audience effectively.- Writes technical concepts clearly and thoroughly for all audience types. Build Partnerships- Cultivates a network of people across a variety of disciplines and functions within the organization.- Builds collaboration by identifying and conveying common interests and priorities, removing barriers, and breaking down silos. - Appropriately involves others in decisions and plans that affect them.- Maintains positive relationships regardless of challenges, organizational level, personality, or background differences. Influence Others - Develops and articulates compelling rationale for positions.- Builds a broad base of support among key decision makers and influencers.- Positions and explains ideas and proposals in ways that get support from others.· Encourages others to find new solutions that improve outcomes and deliver value. Develop Self and Others - Continuously develops interpersonal skills to build effective internal and external relationships. · Models company values and always acts with integrity.· Looks for opportunities to develop breakthrough ideas and initiatives.Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

If you are a current Jazz employee please apply via the Internal Career site. \n Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and their families. We are dedicated to developing \nlife-changing medicines for people with serious diseases — often with limited or no \ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. Please visit\n more information. \n THIS IS A REMOTE BASED OPPORTUNITY IN THE UNITED STATES The Director, Global Medical and Promotional Regulatory Affairs will be a member of Jazz Pharmaceuticals’ Global Medical and Promotional Regulatory Affairs group and will be assuming a leadership role in the promotional materials review; will be responsible for directing the regulatory aspects of internal and external communications, including advertising and promotional activities in the US; will provide insight, judgment and sound decisions on promotional and non-promotional programs and tactics for assigned products in oncology or assigned therapeutic area. The Director works autonomously and collaboratively with Regulatory, Medical, Legal/Compliance and Commercial organizations. The individual develops and applies expertise to ensure promotional programs and tactics are compliant with regulations and company policies while supporting the achievement of business objectives. Essential Job Functions: * Lead the promotional material review committee (PMRC) for assigned products/therapeutic areas in the US for Jazz Pharmaceuticals. * Provides input on decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of FDA promotional regulations, corporate standards and policies and business objectives * Presents clear position statement and risk analysis to leaders in the regulatory department, medical affairs and other departments as needed * Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product in oncology. * Provide regulatory advice, and support to the organization. * Lead the PMRC process and manage regulatory aspects of the review and approval for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to the Office of Prescription Drug Promotion (OPDP) in a timely fashion. * Effectively partner with Regulatory colleagues, Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materials * Exercise independent leadership skills and regulatory subject matter expertise * Work closely with the Promotional Regulatory Affairs lead and other team members to develop regulatory subject matter expertise and leadership skills * Provide regulatory support for Medical Affairs Review Committee (MARC) * Contribute to the development of regulatory strategy through assigned Global Regulatory team * Lead interactions with FDA/OPDP for assigned product(s) including submission of materials for advisory comments for full approval and accelerated approval products. * Further develop depth and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Interprets and communicates FDA perspective to relevant stakeholders and recommends policy and/or process changes as needed, consulting with Regulatory colleagues as appropriate Required/Preferred Education and Licenses: * B.S or B.A. degree in a scientific discipline or equivalent (a non-scientific degree with industry experience to compliment the degree). * Advanced degree in a scientific discipline (e.g. PharmD) strongly preferred. * Substantial pharmaceutical industry experience with proven experience in regulatory affairs advertising and promotion * Experience with Oncology and new product launch support is strongly preferred * Strong understanding of FDA regulations and guidelines * Strong judgment and decision-making skills * Excellent collaboration, verbal and written communication skills Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $188,800.00 - $283,200.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .

Job DescriptionAbout Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced Clinical Research Nurse to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Philadelphia, managing high-priority interventional clinical studies across multiple therapeutic areas. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Hybrid schedule: 4 days on-site (Philadelphia), 1 day remote weekly., • Under the direction of the Director and Clinical Investigators, this role will support the planning, implementation, and execution of multiple concurrent clinical research studies, including NIH-sponsored, industry-sponsored, and investigator-initiated trials., • Work independently managing day-to-day research activities from study start-up to close-out., • Act as liaison between investigators, research teams, and sponsors to ensure timely delivery of services., • Perform nursing assessments and procedures, such as conducting comprehensive nursing assessments, obtain vital signs, review medications, document patient information/instructions in the medical record, complete appropriate forms., • Perform any procedures required for the patient such as drawing blood, conducting EKG's etc., • Collect and interpret clinical and research information related to the patient visit., • Appropriately field/triage patient telephone calls regarding medication changes, clinical status, prescription renewals, or changes in condition., • Coordinate patient recruitment, enrollment, consent, and retention., • Schedule and conduct participant study visits, maintain databases, and ensure accurate data collection/entry., • Manage regulatory binders, IRB submissions, and compliance with FDA, IRB, and GCP guidelines., • Monitor safety events, prepare reports, and support sponsor/audit visits., • Maintain study records (OnCore, Epic, ClinicalTrials.gov) and oversee research billing reviews., • Assess and report study patients appropriately for serious/unexpected adverse events (SAEs)., • Consistently meet or exceed enrollment targets., • Professional licensure as a Registered Nurse in the Commonwealth of PA., • Preferred Education: Bachelor’s degree in Nursing or health-related field., • Phlebotomy certification., • ACLS or BLS certification is preferred., • Two (2) or more years of experience as a nurse in a hospital setting., • Some experience in a clinical trials setting is required such as patient recruitment/retention, IRB submissions, data management, and SAE reporting., • Proficiency with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred)., • Strong Microsoft Office skills (Word, Excel, PowerPoint)., • Excellent written and verbal communication skills; ability to work effectively with diverse populations including faculty, staff, sponsors, and research participants., • Compassionate, professional demeanor and confident with patient education, translating complex concepts into understandable language., • Critical thinker with a proactive, detail-oriented mindset., • Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR DXnS8TKjwK

Job Description LHH Recruitment Solutions has a 3rd SHIFT Maintenance Mechanic opening for our beverage manufacturing client in the Bensalem, PA area! This is a UNIONIZED role. This direct hire role allows you to utilize your training and experience of food and beverage manufacturing plant maintenance and lead the way for process and procedural operational improvements. You will be a critical component in resolving issues related to safety concerns, inspections, trainings and foster a proactive safety-first culture. You will be responsible to work collaboratively with other department supervisors to deliver successful accountability measures and key objectives consisting of continuous improvements and trainings as well as PSM – Process Safety Management. Hourly range: $39.11 per hour. RESPONSIBILITIES: * Aid in and maintain machinery due for maintenance including but not limited to – aid in scheduling of employees, scheduling downtime of machinery, training, budget and cost management, etc. · Troubleshoots equipment as well as resolve mechanical issues related to any equipment malfunctions and breakdowns and/or suspected future breakdowns. · Work collaboratively with the maintenance team and upper management as well as successfully independent. · Identify and clarify project priorities and provide direction to maintenance staff regarding [project status and expectations. · Ensure team performance is meeting all quality standards. · Work within CMMS system, work orders and project management. · Works with process improvement teams to identify, evaluate, and implement any improvement opportunities through changes to operating procedures, policy changes, maintenance procedures, and equipment upgrades. · Identify and utilize preventive and predictive maintenance techniques to minimize equipment breakdowns consistently. · Has a vast understanding and is capable of working with 110V up to 480V electric circuits. · Knows and is able to work and trouble shoot single and three phase motors. · Aid in the creation, development, maintain, and implement preventative maintenance systems as well as maintain the plant PM program. · Ability to understand manufacturing line control and bottle flow. · Consistently demonstrates a current understanding and ability to repair all plant machinery. · Must be able to identify and troubleshoot motor wiring, switches, fuses, and other common electrical failures. · Must possess the capability to build/fabricate steps, supports, brackets, structures, etc. as needed. REQUIREMENTS: · PLC programming and troubleshooting experience highly preferred. · College degree and/or certifications highly preferred. · Beverage manufacturing expereince required. · Proven utilization of knowledge of electrical, industrial controls, mechanical, hydraulic, and building maintenance. · Proven knowledge and implementation of continuous improvement techniques such as 5S, Lean, TPM. · Knowledge of good manufacturing practices (GMP). · Thorough and current understanding of OSHA/FDA/USDA/EPA requirements in a food and/or beverage manufacturing environment highly preferred. · Knowledge and experience utilizing a CMMS to request, plan, execute and analyze maintenance activities. · Sufficient physical ability to work in a manufacturing production environment. · Ability to speak and hear; ability to stand, walk, climb stairs, stoop, bend, and/or crouch; push/pull; lift up to 50 pounds as needed. · Exposure to seasonally wet and humid conditions and fluctuations in seasonal temperature. · Ability to squat, kneel, and must have the ability to reach above and at shoulder height. · Must have the ability to wear a mask if needed and/or dust mask. · Must be able to maintain knowledge of and exposure to toxic and corrosive chemicals. · Must be able to visually and auditorily detect obstacles and potential dangers in a production environment setting. Health insurance, dental insurance and life insurance are offered with this full-time direct hire role. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Pay Details: $39.11 per hour Search managed by: Laura Orozco Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job DescriptionJOB DESCRIPTION SENIOR PROJECT MANAGER Project Management Department Reports to: Associate Director of Project Management Job Summary The Senior Project Manager (Sr PM) is energetic and committed to holistically managing a complex array of integrated marketing tactics, ranging from medium to large-scale cohesive programs. This person is responsible for managing the creation of project plans and driving digital projects from conception through to implementation. Attention to detail and consistency are critical attributes to have for this role. The Sr PM is the problem-solving partner to the account leads for all things logistical, playing an important and proactive role in helping to identify and manage project risks while leading the agency team to meet its deliverables with both decisiveness and confidence. Additionally, the Sr PM will provide some supervision to more junior team members (Project Coordinators, Project Managers). As the steward of agency process, the Sr PM champions the appropriate steps throughout the project life cycle, connecting the right team members at the right time at each step of the way. The Sr PM has a proactive, can-do attitude, with a sense of urgency and willingness to take on additional tasks when necessary. The right candidate will have a strong personality and be direct in team communications but will exhibit professionalism and diplomacy while building strong relationships across agency disciplines and with external partners. This person projects a calm, positive attitude toward peers and conveys confidence without overpromising on expectations. Key Job Responsibilities (Duties may include, but are not limited to all or some of the following) PM Methodology: Applies Calcium+Company’s methodology in project plans, contracts and status reporting. SOWs: Prepares complex statements of work. Creates or reviews estimates and statement-of-work documentation; accountable for top-down and bottom-up budgets to ensure scopes accurately reflect the required work effort Project Finances: Expertly manages project-level finances based on brand fee structure and accurately calculates cost-to-complete estimates Resource Allocation: Responsible for ensuring that all needed assets and resources are identified at a project level to successfully meet client expectations. Partners with Director of Project Management to address resource needs and project staffing Technology: Continuously learns and adapts to new technologies while applying a strong knowledge of software development life cycles, web technologies, and web development processes to deliver creative solutions Managerial Skills: Mentors and goal sets with junior staff. Delivers yearly employee reviews Internal Relationships and Team Leadership: Positive influence within the discipline; develops strong and positive working relationships with other discipline leads and project stakeholders, motivating project teams to excel while supporting their various work streams to ensure adherence to objectives, process, and timelines * • Continually brings innovative solutions to creative teams and explores tools to help teams function more efficiently, • Schedules and leads internal status meetings and reviews; keeps teams informed of all project status/next steps via daily hot sheets and regroups, • Demonstrates critical and strategic thinking skills and take solution-oriented and flexible approach, • Cleary articulates project status creep and red flags to full team and helps devise and drive remedies. 2 Job Qualifications (Skills/Requirements), • Bachelor's degree required, • 5 years of experience in digital/print production of marketing sales materials (print and digital sales aids, videos, responsive websites, banner ads, email tools, etc), • Advanced in project management via a flexible approach and familiar with different project methodologies, • Experience managing $4-6M pharmaceutical brand teams in an agency environment, • Product launch, med/legal, and FDA 2253/OPDP submission experience, • Skilled and seasoned with web development projects, life cycle management, analytics, and, • strategy, • Microsoft Office Suite: Word, Project, Excel, PowerPoint; JIRA or other web development tools, Acrobat Professional; web-based routing and project management system administration, • Expert in project level financial management, including different fee structures (fixed, T&M, retainer, etc), • Problem solver with excellent communication skills, • Proven ability to multitask and handle stressful situations and deadline pressures EOE/AA/M/D/V/F3. Powered by JazzHR pesUbyo3Wh

Job Description WHO WE ARE Baldwin Richardson Foods is focused on enriching the flavor of life. As a full-service liquid products supplier and strategic partner to the food and beverage industry, Baldwin Richardson Foods combines its formulation expertise and unique packaging options with robust processing capabilities to produce high-quality sauces, toppings, syrups, fillings, and shelf-stable beverages for the world's most iconic Quick Service Restaurants (QSRs), Consumer Packaged Goods (CPG) brands, and food service companies. Its state-of-the-art Innovation & Culinary Center transforms trends and culinary inspiration into legendary products through an award-winning commercialization process. The company also manufactures and markets Mrs. Richardson's dessert sauces and Nance's mustards/condiments in addition to producing finished goods for the private label sector. BRF maintains its headquarters and a manufacturing facility in Macedon, New York; with a Culinary Innovation Center in Westmont, Illinois; and offices and manufacturing facilities in Williamson, New York; Pennsauken, New Jersey; and Corona, California. This role can report into any of our manufacturing facilities to include: Corona, CA/Pennsauken, NJ/Macedon, NY or Williamson, NY (hybrid with up to 40% travel). WHAT WE NEED The Sanitation Program Manager is vital for reducing microbiological and chemical risks and preventing product contamination and will be responsible for directing the Sanitation program across the organization's manufacturing locations. This role is essential in ensuring all current Food Safety Standards are met and driving sanitation excellence throughout the enterprise. The Sanitation Program Manager will develop, implement, and maintain comprehensive sanitation and hygienic design standards and programs, including SSOPs, and ensure their consistent application company-wide. This role will provide sanitation expertise, training, and troubleshooting support and will be responsible for the management of sanitation chemical programs and pest control across all sites. Through regular audits and inspections, this role will identify risks, provide guidance, and ensure adherence to standards and regulations. WHAT YOU WILL DO Leadership & Oversight • Direct sanitation and production teams to ensure safe, effective cleaning (CIP, COP, manual)., • Develop and standardize sanitation programs and procedures, including SSOP, HACCP, FDA, USDA, BRC, and SQF standards., • Maintain and annually review the Master Sanitation Schedule and SSOPs., • Manage sanitation changeover matrix and support new product cleaning needs., • Troubleshoot sanitation and quality issues; implement corrective actions., • Ensure compliance with safety protocols, PPE use, and training requirements., • Maintain documentation for regulatory and customer audits., • Partner with Quality/Food Safety to validate sanitation effectiveness., • Coordinate corrective/preventive actions for environmental monitoring and allergen validation., • Supervise microbiology team; ensure accurate, timely testing using validated methods., • Oversee external partners (chemical suppliers, pest control)., • Analyze chemical needs; recommend vendors with Procurement., • Maintain chemical safety procedures and SDSs., • Lead chemical handling and sanitation training (onboarding and annual). WHAT YOU WILL NEED TO BE SUCCESSFUL • Bachelor’s degree in Food Science, Microbiology, Chemistry, or related field (Master’s preferred)., • Multi-site experience is preferred., • 5+ years of experience in food manufacturing (or closely related industry) sanitation, including CIP/COP systems., • Strong knowledge of food safety standards (FDA, GFSI (SQF), HACCP, GMP)., • Experience being the subject matter expert in sanitation programs, audits, and regulatory compliance., • Proven leadership skills, including cross-functionally/outside of direct management., • Familiarity with environmental monitoring, allergen control, and microbiological testing., • Knowledge and experience with Aseptic systems and Sterilization in Place (SIP) is preferred. At BRF, base pay is one part of our total compensation package and is determined within a range. Your base pay will depend on your skills, qualifications, experience, and location. You’ll also receive a comprehensive benefits package including a low premium and out of pocket cost medical, dental and vision coverage, 401k with company match, generous sick and vacation time, 9 paid holidays, birthday and floating holidays, volunteer time and more! #LI-EB1