Quality assurance manager jobs in Forks, PA - 100 jobs

Quality Assurance Operations Supervisor Essential Duties and Responsibilities Overall responsibility for coordinating the disposition of API and drug product Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements Supervises day-to-day functions of the QA Operations team Mentors/coaches and provides succession planning for direct reports Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures. Ensures QC data meets specifications and any OOSs are investigated per internal procedures Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs Prepares metrics for weekly, monthly and quarterly Management meetings Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e. Critical Thinking skills using “Risk Based” logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches Attention to detail/ sense of urgency- ability to act quickly and escalate issues Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers Excellent verbal and written communication skills Energetic, enthusiastic, and motivational disposition Education/Experience Bachelor's degree required with Bachelor of Science preferred 5+ years' experience in Pharmaceutical/Biotech industry Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

Job Title: QA Document Coordinator Duties: Assist with adminstrative activities including but not limited to: Proper labeling of all documents (2250+) documents in and entering document Archive Room Logbook generation and issuance Support shipping of documents offsite to Iron Mountain (secure GMP facility for documents) and ensure all documents are scanned prior to shipment Other administrative duties as needed Skills: Exceptional organization and time management skills Strong attention to detail with the ability to work accurately in a busy and demanding environment Ability to successfuly work within strict timelines Excellent work ethic Education: Minimum Associates Degree

Remote: No About the Job Arencibia is the leading provider of gas monitoring, analytics, and recovery solutions. We help the world's largest manufacturers in metals, aerospace, automotive, semiconductors, and other industries transform the economics, reliability, and predictability of their gas supply chain while delivering significant environmental benefits. We own and operate industrial gas recovery systems and our proprietary Monitoring, Analytics, and Recovery Service (MARS) to reduce gas supply costs, increase predictability, and provide unprecedented insight into manufacturing operations. Arencibia's operating and maintenance function is based in Quakertown, PA. As an R&D Manager Semiconductor Systems, you will lead and support research and development activities focused on semiconductor related gas systems, testing platforms, and advanced process gas technologies. This role combines hands on technical leadership with strategic planning, experimental design, and resource management to enable effective semiconductor focused testing and development. You will work closely with internal R&D, Process Engineering, and Controls teams to design experiments, evaluate equipment and systems, and mature new technologies from concept through validated performance. Responsibilities Include: Lead semiconductor focused R&D initiatives related to process gas delivery, gas monitoring, purification, and scrubbing technologies. Support the design, build, and operation of laboratory and pilot scale test systems for semiconductor gas applications. Define experimental objectives, test plans, and validation strategies for semiconductor related testing activities. Manage laboratory resources, equipment utilization, and testing schedules to ensure efficient execution of R&D programs. Collaborate with internal R&D and Process Engineering teams to evaluate equipment specifications, system designs, and performance data. Support technical evaluations of process equipment, including gas analyzers, flow meters, compressors, pumps, valves, purification modules, and associated instrumentation. Coordinate with equipment vendors to review technical documentation, evaluate system capabilities, and support equipment selection and integration. Maintain clear, accurate, and well organized technical documentation, including test protocols, experimental results, specifications, and design records. Participate in technical reviews, root cause analyses, and data driven decision making to guide development priorities. Travel to customer or vendor sites as needed for testing support, equipment evaluation, or technical coordination. Occasionally lift and or move up to 40 pounds. Strong Candidates Will Have: PhD, Master's, or Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical discipline. More than five years of experience in the semiconductor industry, with hands on involvement in process gas systems, gas scrubbing, gas monitoring, or related technologies. Strong understanding of semiconductor process gas requirements, contamination control, and system reliability considerations. Experience designing and executing laboratory or pilot scale experiments for gas or semiconductor related systems. Ability to interpret and evaluate P&IDs, process flow diagrams, equipment specifications, and technical drawings. Demonstrated ability to manage technical resources, testing priorities, and complex development activities. Strong analytical skills with the ability to interpret experimental data and translate results into actionable insights. Excellent written and verbal communication skills, with the ability to clearly document and present technical information. Detail oriented and structured approach to experimental design, documentation, and process improvement. Experience with cryogenic systems, inert gas handling, or high purity gas applications is a plus. Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance

Bethlehem, PA $60,000-$70,000 base + bonus No C2C | No Sponsorship | No Relocation Assistance A growing pharmaceutical manufacturing site has a full-time opportunity for a Quality Assurance Compliance Specialist to join a friendly, collaborative QA team. Job Summary: Support GMP operations with a strong focus on batch record review, documentation control, and product release activities. This is a hands-on QA role in a regulated manufacturing environment with strong visibility and growth potential. Key Responsibilities Review manufacturing and packaging batch records (paper & electronic) for product release Review laboratory data and generate Certificates of Analysis (C of A) Release product in SAP and generate quality reports as needed Support documentation control, archiving, and QA record management Review calibration records and support quality systems compliance Assist with deviations, investigations, APRs, CRNs, BOMs, and MBR updates Support internal and regulatory audits (FDA and other agencies) Support packaging line inspections as needed Train new QA team members and provide cross-coverage within QA Assist with new product launches and special QA projects Qualifications Bachelor's degree in a science or technical field (Chemistry preferred) or equivalent experience 5+ years of experience in a regulated industry (pharmaceutical or medical device) Strong knowledge of FDA regulations, GMPs, GDPs, and GLPs Experience in manufacturing and/or packaging environments Familiarity with quality systems and documentation control Microsoft Office proficiency; SAP, TrackWise, and EDMS experience a plus Strong communication, problem-solving, and critical-thinking skills

Title: Inventory Quality Specialist About Midea Midea Group is one of the world's largest home appliance brand, offering the most comprehensive selection of products in the world to fully serve the needs of day-to-day living at home, at work, or anywhere else you go. We strive to aim high, put the customer first, transform and innovate the marketplace, utilizing our commitment, dedication, inclusion and partnership with our teams. Midea is a global company operations in more than 195 countries. As a publicly listed company, we are also ranked #245 as a Fortune Global 500 company and offers one of the most comprehensive ranges in the home appliance industry. Midea America is a subsidiary of Midea Group in the US. Job Summary Midea America is seeking a highly organized, detail-oriented Warehouse Inventory Controller to support inventory accuracy, quality, and control within our regional distribution center in Pennsylvania. This role is critical to ensuring system integrity, physical inventory accuracy, and compliance with customer, financial, and operational requirements. The Inventory Controller owns inventory governance across the DC-overseeing audits, discrepancy resolution, rework and returns, aged inventory management, and WMS execution. This role partners closely with Warehouse Operations, Finance, Quality, Reverse Logistics, Compliance, and third-party logistics providers (3PLs) to ensure inventory accuracy, accountability, and continuous improvement. Essential Job Responsibilities Inventory Accuracy & Control Lead and oversee physical inventories and cycle counts; plan, schedule, and execute mid-year and year-end inventory audits. Investigate, reconcile, and resolve inventory discrepancies (shorts, overages, damages, loss) in a timely and accurate manner. Ensure all inventory adjustments are supported by root cause analysis and properly executed in the WMS. Monitor shrink-related incidents (damaged product, dropped pallets, losses) and ensure real-time system updates while holding 3PLs accountable per contractual terms. Review and correct inventory imbalances using systematic in-house transfers. Quality, Compliance & Rework Oversee isolation and disposition of returned, recalled, quarantined, and rework inventory. Direct warehouse staff on corrective actions leading to final stock resolution (A-Stock, liquidation, scrap). Conduct inventory quality audits, including inventory accuracy, damaged product segregation, and outbound quality standards (pallet integrity, overhang, wrapping, strapping, and load securement). Partner with Midea Compliance and customer portals to reduce chargebacks and compliance penalties. Ensure DC teams follow SOPs for receiving discrepancies, shortages, and damage documentation. WMS & Master Data Management Ensure proper WMS execution to maintain inventory accuracy and visibility. Manage item master attributes including TI-HI, stack height, pallet configuration, inventory grade, and demand type. Recommend optimal placement strategies for seasonal, e-commerce, rework, and quarantined inventory. Generate and manage RMAs to support reverse logistics and systematic receiving processes. Operational Support & Reporting Respond promptly to inventory-related inquiries from Operations, Order Management, Sales, Procurement, Quality, Reverse Logistics, Finance, and Senior Leadership. Monitor and report on inventory turns, aged inventory, seasonal readiness, and high-velocity e-commerce SKUs. Communicate rework timelines, costs, and quality issues to Finance and cross-functional stakeholders. Monitor productivity of quality and rework labor to ensure value-added work is completed on time and within budget. Safety & Supply Management Communicate and enforce all safety policies; conduct self-audits to ensure compliance. Maintain warehouse supply inventory (pallets, stretch wrap, labels, etc.) and track usage levels. Required Qualifications Bachelor's degree in Logistics, Supply Chain Management, or a related field (required). Minimum of 5 years of experience in a warehouse or distribution environment (preferred). At least 5 years of supervisory or lead-level experience (preferred). Strong working knowledge of Warehouse Management Systems (WMS); YMS experience preferred. Advanced proficiency in Microsoft Excel; strong skills in PowerPoint and Word. Excellent written and verbal communication skills with the ability to collaborate cross-functionally. Strong planning, organization, and problem-solving capabilities. Ability to operate effectively under pressure in a fast-paced, changing environment. Customer-focused mindset with a high level of ownership and accountability. Ability to spend extended periods on the warehouse floor while adhering to all safety requirements. Must be authorized to work in the United States. Featured benefits Insurance package. 401(k). Work life balance. Comprehensive benefit package, to learn more, please visit Careers Page (midea.com) Midea America Corp. is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics

Primary Duties & Responsibilities Lead SiC LLC Quality Function Build strong organization quality talent in SiC LLC plants. Actively engage in resolving customer quality issues and prepare for customer audits. Drive total customer satisfaction. Coach the plants towards a culture of prevention. Establish strategic quality direction within the plants. Teach advanced Quality classes at the plants. Establish a culture of intelligent risk-taking and guide the plants in choices to help exploit strategic opportunities. Lead in strategic decision-making, and in tactical decision making within important risk-saturated areas. Ensure Quality systems are aligned with identified best-practices. Lead and manage the quality functions at SiC LLC plants. Design and lead production of various dashboards accurately depicting quality product and process status in all plants. Create and Maintain QMS Alignment with the Coherent Global Quality System Ensure Quality Manual aligns with Coherent Corporate Global Quality manual. Establish and maintain a process for “Preventive Action Efficiency” to drive mistake-proofing in the factories. Implement and maintain Coherent Global COQ process. Implement and maintain coherent Global KPI process. Implement and maintain Coherent Global QBR. Implement and maintain Coherent Global Risk Assessment process. Implement and maintain the Coherent Global QAT-based assessment QMS effectiveness. Implement and maintain Coherent Global Purge process. Implement and maintain Coherent Global Quality Stop process. Implement and maintain Coherent Global NPI process. Implement and maintain Coherent Global PCN process. Lead the Development and Implementation of IAFT 16949 QMS Conceive, design, develop, implement, and continually improve an IATF 16949 certified QMS. Lead efforts to identify, develop, proceduralize, and implement best quality AIAG practices in all SiC LLC plants. Guide best practice design and deployment of processes for PPAP, SPC, MSA, APQP, and FMEA. Implement Coherent Corporate Global internal quality audit process to ensure continual compliance and improvement of the automotive QMS. Design and implement periodic Management Review processes to drive continual improvements. Implement the Coherent Corporate Global 8D corrective action database and ensure its optimum usage. Develop and maintain a Quality Manual. Implement and maintain key complimentary processes within SiC LLC Export compliance is maintained. Ensure implementation and maintenance of Coherent Lean process. Implement and maintain necessary ESD processes. Implement and maintain necessary ESG processes. A quality work environment consistent with 6S practices is maintained. Assure regulatory compliance in product-related areas such as RoHS, REACH, and Conflict Minerals. Education & Experience M.S. in technical field, preferably Statistics, Mathematics, or Industrial Engineering. Extensive experience with Quality Sciences and Quality Management. 20 years Quality Engineering, Quality Management, or Quality Consulting. 15 years of experience electronics or semiconductor manufacturing. 20 years of experience in internal quality audit. 10 years of experience managing tier-1 or tier-2 customer audits. 10 years of experience in using structured techniques to solve complex problems. Awareness of PPAP, FMEA, MSA, Control Plan, and SPC techniques. Awareness of lean manufacturing techniques. Due to ITAR compliance, this position requires candidates to be a U.S. Citizen, Permanent Resident Alien, or Protected Individual per 8 U.S.C. 1324b(a)(3). Skills & Other Requirements Expert Knowledge of the ISO 9001 criteria. Awareness and understanding of the IATF 16949 criteria. Process characterization and control techniques. Able to balance financial and quality objectives. Statistical expertise including FMEA, SPC, DOE, MSA, Process Capability. Able to understand AIAG process control plans. Able to facilitate cross-functional Kaizen Events. Solve complex problems using intuition, induction, deduction, analysis of data, and advanced quality tools, and structured problem-solving methods. Effectively work in cultures throughout North America, Europe, and Asia. Able to think critically and to reengineer all elements of an Automotive Quality System to remove waste of time and dollars, while increasing Quality performance. Willing to take intelligent risks to gain opportunities for quality innovation. Excellent interpersonal, communication and presentation skills and ability to comprehend and communicate at a high level with executives, senior managers, and global customers, suppliers, and principals at different sites. Able to relate well and work collaboratively with all levels within a site, from senior leaders to production operators. Ability to deal effectively with differences of opinion, to influence, to draw ideas from others, and to negotiate and mediate. Ability to anticipate and handle multiple priorities and complex/abstract issues involving external and internal priorities. Ability to excel in a cross-organizational, cross-cultural, global team environment and to easily adjust in the face of challenge and change. Handle special assignments promptly and professionally. Maintain a high standard of ethics, professionalism, leadership, and competency. Proven ability to lead and motivate people. Demonstrates and promotes the Coherent ICARE Worldwide Values. Knowledgeable in worldwide ESG norms. Working Conditions Office Environment Manufacturing Plant Environment, on occasion Physical Requirements Ability to work at computer Safety Requirements All employees are required to attend scheduled training, follow the site EHS procedures and Coherent Corporate EHS standards. This includes the use of proper protective equipment (PPE) as required by the job responsibilities. Managers will ensure that all safety and environmental procedures are followed consistently. They will ensure that risk assessments are performed, proper training, work instructions, required PPE is available, and will monitor compliance. Quality & Environmental Responsibilities Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Culture Commitment Ensure adherence to company's values (ICARE) in all aspects of your position at Coherent: Integrity - Create an Environment of Trust Collaboration - Innovate Through the Sharing of Ideas Accountability - Own the Process and the Outcome Respect - Recognize the Value in Everyone Enthusiasm - Find a Sense of Purpose in Work

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: Johnson & Johnson is currently recruiting for Director of Sterility Assurance! This position will be located in Raritan, NJ. Position Summary: The Director of Sterility Assurance is a leadership role responsible for overseeing all microbiological and virological control aspects of cell and gene therapy product manufacturing at the Raritan facility. This role ensures the safety, quality, and compliance of our products and processes through the development, implementation, and management of robust testing programs, risk assessments, and quality systems. The Director will provide technical expertise and strategic direction in microbiology and virology. The candidate will consult with JNJ manufacturing facilities, Global and Site Quality and Global Sterility Assurance and other functions to educate on the Sterility Assurance program requirements and proactively ensure compliance of the JNJ Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Responsibilities: Raritan Site Quality Management Responsibilities (80%) Develop, and maintain oversight of comprehensive microbiology and virology programs, including environmental monitoring, incoming material testing, in-process testing, lot release testing, and stability testing. Serves as primary point of contact and decision maker for internal policies, procedures, and strategy documents governing Sterility Assurance and Contamination Control related topics. Support in knowledge advancement beyond the Quality organization to build, maintain, and develop capabilities across the JNJ network for the Sterility Assurance space. Development of knowledge-based programs to advance company education and training programs. Provide mentoring leadership to stakeholder SMEs to build capability for new and existing sites or where gaps in technical expertise have been identified. Sponsor and oversee activities focused on driving process improvements and harmonization projects across the JNJ network for Sterility Assurance and Contamination Control. Serve as the SME leadership role for topics associated with Sterility Assurance and Contamination Control across the network, representing on network teams and other appropriate governance forums. Provide technical support to during new process design and facility change activities to ensure Sterility Assurance programs and product requirements are supported at the sites. Engage in providing support during regulatory submissions and on-site inspections. Define and execute the process for managing observations and commitments related to Sterility Assurance for the Raritan. Accountable for transformation of sterility assurance global standards across Engineering, MSAT and Quality and ensuring that they are in use across all sites. Set vision for the future to proactively meet regulatory expectations. Accountable for program management for execution / implementation to global standards Deliver Annex 1 compliance through standardized global policies. Implement KPI dashboards for contamination control. Define clear project and governance frameworks to clarify roles and responsibilities between global and local teams. Drive continuous improvement and proactive inspection readiness with storyboard creation and coaching/mentoring. Lead the uplift in capability building and leadership development across functions. External network/advocacy with industry forums and regulators to keep pace with evolving regulatory expectations and emerging technology. Leadership Team Responsibilities (20%) Sets and manages targets and objectives for the Raritan site ensuring alignment with overall company strategy. Drives the achievement of annual goals, guided by Our Credo and leadership principles. Builds and sustains strong relationships with internal and external stakeholders, including Global Quality teams, Manufacturing, Quality Control, Facilities and Engineering, and partners. Coordinates quality-related activities across departments, sites, and organizations to proactively support and optimize business processes. Ensure the Sterility Assurance department has a clear organizational structure, with robust formation and succession plans to support long-term stability. Provides leadership to build a high-performing, collaborative team through hiring, mentoring, and talent development. Champions a culture of quality compliance, diversity, inclusion, and continuous improvement. Manages professionals within the Quality team, fostering ongoing talent development and succession planning. Collaborates with the VP, IMSC Quality, and other site Quality Heads as part of the Advanced Therapies Quality Leadership Team (ATQLT) to ensure harmonization and standardization across sites. Partners with cross-functional leaders to support continuous improvement and lifecycle management of GMP policies and the QMS. Represents Raritan in the planning, development, and execution of corporate Quality initiatives. Establishes effective partnerships across business units, sites, and functions to ensure integrated and efficient business processes. Qualifications: Education: A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, engineering, chemistry, microbiology or related scientific / engineering discipline preferred. Masters or advanced degree preferred. Required: Minimum of 10 years of Quality Assurance / Quality Systems experience related to manufacturing Comprehensive knowledge of vaccines, biological manufacturing and related Quality management processes and systems Proven people management and Quality leadership experience Strong people leadership skills and a proven track record in attracting, developing and retaining talent in the organization Comprehensive regulatory cGMP and technical knowledge to develop sterility assurance strategies necessary to maintain the desired level of inspection readiness Experience hosting global regulatory agency inspections and successfully presenting product and quality compliance programs to regulatory reviewers Experience with implementing and overseeing cGMP operations in a commercial manufacturing facility Demonstrated experience building and leading exceptional Quality Assurance, Quality Systems and Quality Control teams Extensive knowledge of chemical, biochemical and microbiological concepts Knowledge of cGMP regulations and FDA/EU guidance Fluent in English (written and spoken) Preferred: Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is highly preferred Strategic thinking with the ability to manage/master complexity and to act as a sponsor for change Ability to prioritize and guide the organization in coping with the demands of a rapidly changing environment Ability to apply appropriate risk assessment strategies to manage business & compliance priorities Effective negotiation and influencing skills and lead with a mindset of continuous improvement Balanced decision-making skills and ability to effectively resolve conflict, when needed Business acumen; develop and control budgets Ability to communicate effectively with different levels in the organization and with health authorities Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource Required Skills: Preferred Skills: Aseptic Processing, Clean Room Manufacturing, Contamination Control, Risk Assessments The anticipated base pay range for this position is : $150,000.00 - $258,750.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

The Senior Manager of QA leads one or more QA teams supporting designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Warehouse, Project and Account Management, Engineering, IT, Incoming Inspection and Documentation) in a contract pharmaceutical packaging facility. The position provides quality oversight, regulatory and cGMP guidance to designated areas within Sharp US Commercial Sites. Responsibilities include, but are not limited to, supervision of quality related activities, troubleshooting quality related issues, making quality decisions regarding issue resolution, and driving continuous quality improvements. This position is responsible for ongoing contact with customer QA representatives regarding quality non-conformances, investigations, change controls, CAPAs, documents, quality metrics, customer quarterly business reviews, audits and audit follow-up related to their designated functional areas. This position is responsible to assist the Sharp audit team and help prepare area owners to lead discussions and tours relevant to their designated areas during customer and/or regulatory agency inspections and work with internal partners to lead and/or drive subsequent actions. The Senior Manager Quality is responsible to ensure both internal and external customers receive the appropriate level of quality support and will serve as the second level of escalation for customer issues or concerns. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, quality issues and documentation requirements could expose the company to significant risk or economic loss. ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to the Senior Manager QA position. Other duties may also be assigned. Leads one or more QA teams associated with designated functional areas of Packaging Operations or Central functions (i.e., Facilities, Engineering, Warehouse, Packaging Services, Incoming Inspection, Documentation, etc.) Responsible for ensuring products and processes meet customer, company and regulatory requirements/standards and participating in internal, regulatory and customer audits as required. Responsible for delivering internal and customer quality KPIs and standards for assigned areas. Responsible for leading and coaching teams through problem-solving initiatives and impact assessments associated with change management and non-conformances as well as the review and approval of quality related documentation. Serve as an escalation point for customers and serve as backup for the site Quality lead during absences. Summarize data, draw conclusions, and turn recommendations into clear actions which can be effectively communicated across all levels of the organization. Identify and lead implementation of continuous improvement opportunities of broader impact (i.e., site or division level). Support designated area to ensure compliance to processes and products and ensure testing, inspection and monitoring programs meet all requirements. Responsible for implementation of initiatives related to quality systems gap resolutions as well as quality improvements. Responsible for contributing to and driving attainment of the short- and long-term quality strategy by understanding the future needs, relative to the required skills and resources needed, to successfully support the business. Responsible to work across the broader quality organization to meet future needs through succession planning, training, development and mentoring of personnel. Responsible to effectively communicate a variety of personnel actions, including but not limited to, employment, termination, performance, discipline, scheduling, and salary review. Performs other related duties as required. by management. QUALIFICATIONS: 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. SUPERVISORY RESPONSIBILITIES: Direct supervision of quality managers and professionals at the local site. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE: Bachelor's degree in science is preferred with seven to ten years of related experience or Associate's degree with ten to fifteen years of related experience or a minimum of fifteen years of related experience. Knowledge of current FDA regulations and current industry practice Thorough knowledge of quality and/or operations required. Knowledge of DEA regulations desired. Broad knowledge of current pharmaceutical industry including packaging practices Above average written and oral communication skills required. Above average organizational and planning skills required. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Approximately 5-10 percent auto travel between sites. Travel to customers on an as needed basis. DISCLAIMER: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Step into a pivotal leadership role at Clemens Food Group, where your impact on food safety, people leadership, and product quality will be seen daily. Internally, this role is called a Superintendent, but externally we're seeking an Assistant FSQA Manager-a role often known in other organizations as a Food Safety Manager, Quality Assurance Manager, or FSQA Manager. In this role, you'll lead a team of QA supervisors and technicians in a USDA-regulated meat processing facility, ensuring compliance with HACCP, SSOPs, GMPs, and audit readiness. As the senior-most FSQA authority on second shift, you'll balance hands-on floor leadership with root cause analysis, corrective actions, and continuous improvement projects in one of our largest protein production plants. Shift Details Shift starts at 3:00 PM and runs for 9 hours As a management-level position, flexibility is expected-shifts may start or end an hour earlier or later based on operational needs On-call approximately one out of every four weekends The Impact You'll Make You'll own the shift. Literally. From running handoffs and leading root cause investigations to coaching your team and making critical decisions during audits or equipment failures-this role gives you end-to-end visibility and influence. Your leadership will drive our KPIs around safety, first pass quality, and regulatory compliance. What You'll Do Lead and develop a second-shift FSQA team (multiple supervisors and techs) Be the point of contact for USDA, customer complaints, and urgent investigations Review and act on trend data to improve quality and reduce CPMs Collaborate cross-functionally with Ops, R&D, and Sanitation Manage issue resolution, floor presence, audits, and on-call response (1 in 4 weekends) Prioritize food safety and people leadership at every turn What Makes This Role Exciting? You're the top FSQA decision-maker on your shift Gain experience in a high-capacity, 1.3M sq. ft. protein facility Every day brings new projects, challenges, and growth moments Room to grow-this role is a stepping stone to FSQA Manager What We're Looking For Proven FSQA leadership, meat/poultry/seafood industry required Proven ability to lead teams and manage performance Strong background in USDA, HACCP, audits, and corrective actions Comfortable with ambiguity, fast pace, and solving complex floor issues Skills & Mindset High initiative: confident in making decisions without constant direction Project-focused: can organize chaos into action plans and results People-first: builds trust, holds people accountable, and develops others Strong communicator: connects across functions, listens well, and presents data clearly Your Future at Clemens This isn't just a shift job-it's a career-building leadership role. We'll support your onboarding, help you get grounded in our culture, and give you visibility that sets the stage for broader advancement within FSQA. Application Note: Clemens Food Group is not accepting unsolicited resumes from search or staffing firms. All resumes submitted by search or staffing firms to any employee at Clemens Food Group via email, the Internet, or directly without a valid written search agreement for this role, and without having been asked to participate in this by Talent Acquisition, will be deemed the sole property of Clemens Food Group, and no fee will be paid in the event the candidate is hired. Firms not authorized to submit candidates will not be eligible for any fee or ownership claim. #LG-AG1 Keywords Food Safety, Quality Assurance, Food Safety Supervisor, FSQA Manager, Assistant Food Safety Manager, Meat Processing QA, USDA Compliance, HACCP, SQF, Food Manufacturing, Protein Industry, QA Team Leader, Quality Systems, Food Safety and Sanitation, Second Shift Food Safety, Regulatory Compliance, Food Plant QA, FSQA Superintendent, Assistant QA Manager. #LI-AG1

Line of Business: Cement & White About Us Heidelberg Materials is one of the world's largest suppliers of building materials. Heidelberg Materials North America operates over 450 locations across the U.S. and Canada with approximately 9,000 employees. What You'll Be Doing Lead and implement quality control programs to ensure product compliance with internal and external standards Monitor production processes and conduct audits to identify areas for improvement Collaborate with operations and technical teams to resolve quality issues and drive continuous improvement Train and support plant personnel on quality procedures and best practices Analyze data and prepare reports to communicate quality performance and trends What Are We Looking For Demonstrated ability to lead quality initiatives in a manufacturing or industrial environment Bachelor's degree or equivalent experience in Chemistry, Chemical Engineering, or related field Strong analytical and problem-solving skills with a focus on continuous improvement Effective communication and collaboration across cross-functional teams Proficiency in quality systems, standards, and tools (e.g., ISO, Six Sigma, SPC) Capability to manage multiple priorities and adapt to changing business needs Work Environment This role operates in a plant environment with exposure to industrial equipment, materials, and processes. Occasional travel to other facilities may be required. What We Offer Competitive base salary ($95,330 - $119,160) and participation in our annual incentive plan 401(k) retirement savings plan with an automatic company contribution as well as matching contributions Highly competitive benefits programs, including: Medical, Dental, and Vision along with Prescription Drug Benefits Health Saving Savings Account (HSA), Health Reimbursement Account (HRA) and Flexible Spending Account (FSA) AD&D, Short- and Long-Term Disability Coverage as well as Basic Life Insurance Paid Bonding Leave, 15 days of Paid Vacation, 40 hours of Paid Sick Leave and 10 Paid Holidays Equal Opportunity Employer - Minority / Female / Veteran / Disabled

Business: Critical Care Department: Quality Assurance Provides continuous oversight of all daily Quality activities to assure compliance with internal procedures and regulatory requirements. Provide proper control, review, and management of site documentation to ensure GMP and regulatory compliance. Key Stakeholders: Internal Quality Assurance Team, Site Management, All Departments Key Stakeholders: External FDA or other health organizations Reporting Structure Directly reports to Quality Assurance Supervisor Essential Duties and Responsibilities Responsible for the review, approval, and disposition of finished product for the site and final CoA signature Facilitates client project management as required ensuring “quality on time and in full” Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed Leads or participates in focused deviation cross-functional investigations, improvement projects Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified Provides assistance to other QA associates and assist with department trainings Provides support to QA management during regulatory audits Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs Performs internal audits and assist in writing reports for audits Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases Maintain the vendor complaint process Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls Performs special projects and/or assignments as indicated by Quality Management Oversee and review of Obsolete material destruction Perform Quality inspections on packaging line as needed Maintain supplier approval program Support/Maintain site Document Control System Review, approve and close out Document Change Requests Tracking of changes using DCC spreadsheet and supporting actions through closure Maintain original documentation archive and Archival of documents offsite Printing of new and revised documents, Issuance of forms, logbooks Review documentation submitted for routing in eDMS for proper formatting and accuracy. Load documents into an electronic Documentation Management System (eDMS) Route documents for approval in the eDMS Recall documentation for audits in a timely manner Performs external audits and assist in writing reports for audits Responsible for maintenance and revision procedures related to document control May require up to 25% travel. Key Competencies (knowledge, skills, and abilities every person must possess to be successful) Critical Thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers Excellent verbal and written communication skills Energetic, enthusiastic, and motivated disposition Attention to detail with strong organizational skills Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports The ability to drive projects in relation to implementation of new workflows and updates to new systems Education / Experience Bachelor's degree in relevant scientific quality assurance / technical field 5+ years of experience Strong understanding of pharmaceutical cGMP, industry standards, and regulations Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels Expert level user for Quality computer systems Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems Thorough understanding of computer system validation and GAMP requirements

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Validation Specialist II/III as part of the Quality team based in Raritan, NJ. Role Overview The QA Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification, process validation, shipping validation, and data integrity. Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, utilities, and facilities qualification, shipping validation, data integrity, and maintenance activities within the site Review and approve qualification/validation documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration) Provide expertise and solutions to issues regarding qualification and validation strategies and documentation Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for all site systems. Assist in the development of validation and qualification related policies, procedures, templates, forms. Provides quality oversight on data integrity of systems, instruments, and equipment used at the site. Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry standards, and global regulations. Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan Site Review and approve change controls, SOPs, non-conformances, and CAPAs associated with qualification/validation execution and ensure effectiveness of related actions. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Drive continuous improvement Other duties may be assigned, as necessary. Requirements A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus. Strong knowledge of GxP compliance. Experience in cGMP regulatory body audits. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and be responsible for a portfolio of ongoing projects. Ability to pay attention to details and follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Experience reviewing/auditing GMP documentation. Strong proficiency with using Microsoft Office applications. #Li-BZ1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$93,463-$122,670 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.

The employee is responsible for maintaining the quality procedures on production lines. They are responsible for handling material using appropriate equipment and processes, while making sure the department complies with company safety requirements, contributes to the quality improvement process and interfaces and communicates within their department. _________________________________________________________________________ Essential Job Requirements: Employee is required to be on the production line thirty, prior to shift startup. Check daily schedules to assure that no changes have taken place Read all work order information prior to start up Review all printed material for accuracy and appropriateness for use Match batch approval to work order signing if information is correct Inspect all codes on lines, jars, bottles, labels, folding cartons, packers, and shippers. Any mechanical problems found at this time should be conveyed to the Mechanic and Line Leader and QC Inspector. All issues concerning paperwork, components or batching will be reported to your Lead. Make sure all information is correct and sign the paperwork. If the information is not correct call your Lead. The Quality Assurance Auditor will be responsible after the shift start up for: The Auditor will insure that the cap is being sealed once an audit. If torques do not meet spec, inform line leader and inspector. Do not leave until the inspector signs your audit paperwork. If weights do not meet spec. inform line leaded and inspector. Do not leave until the inspector signs your audit paperwork. Aesthetics of the line are to be inspected. This will include label placement, dirt on containers, grease on bottom, etc. Any problems inform the line leader, inspector and call your lead if needed. At the end of the shift the job order duties are as follows: Employee will place all paperwork into the designated area. Employee will complete all paperwork for the next day before their departure. The Auditor will question the Quality Control Lead if they do not understand the requirements of the task to be performed. The employee reports to the Quality Control Lead and their work is reviewed or directed by this Lead, with monitoring of major job duties. Receiving this supervision is necessary, but not critical for successful job performance. Requirements Physical Requirements/Working Conditions • Employee is required to pass a drug and/or alcohol test. • While performing the job the employee must be able to stand and walk constantly during shift. • While performing the job the employee must be able to sit, push/pull, climb, stoop/crouch, crawl/kneel, twist, balance and reach occasionally during shift. • While performing the job the employee must be able to lift and carry 25 to 50 lbs frequently during shift. • To perform this position, the employee must be able to read and write English and do mathematical calculations. Hours: 6:00am - 3:00pm

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Job DescriptionWe are seeking an innovative, creative, and detail-oriented Quality Control Sample Coordinator to join our team in Bridgewater, New Jersey. This individual will play a critical role in ensuring the seamless handling, tracking, and shipping of analytical samples in support of assay execution for the Quality Control (QC) teams. This position acts as the central point of contact between Manufacturing, Analytical teams (multi-site), and other cross-functional stakeholders in managing sample logistics and documentation. All activities are performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures. Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.Responsibilities Create and maintain sample schedule, from sample creation through QC testing Track sample shipments between internal and external sites Receive samples from clients or other Cellares sites and ensure proper logging, handling, & reconciliation Maintain visibility into sample storage locations, including LN2 and -80°ree;C freezers Manage documentation related to the shipping and receiving of samples Document sharing & coordinate ordering cryoports/cryopods with the Warehouse team and coordinate shipment/reshipment logistics for analytical samples Be comfortable working with LN2 systems Work with QC teams in developing and managing sample batching approaches Deliver required samples to the QC team in real time Monitor for and address discrepancies (labels not accurate, vial missing, wrong concentration, etc) proactively Be available to support unplanned analytical re-executions Review the assay execution schedule and monitor turnaround times for data release to ensure alignment with project timelines Ensure sample retains are shipped to appropriate long-term storage locations after assay execution Assist in general upkeep of the laboratory and maintain a clean work environment Perform other duties as assigned Requirements Bachelor's degree in a science discipline required, or comparable experience 2+ years of experience in cGMP or cGxP at an operational level supporting manufacturing in a pharmaceutical or biotech environment is preferred Prior experience related to LN2 sample handling is preferred Prior experience with scheduling/planning tools (e.g Binocs) is preferred Knowledge of pharmaceutical cGMP (US and EU) is preferred Must have excellent verbal, written, interpersonal, and organizational and communication skills Must be able to commute to Bridgewater, New Jersey Self-awareness, integrity, authenticity, and a growth mindset Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.This is Cellares Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing. Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process. 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.

Job Details Primary Function: Assist in facilitating the work of Quality Assurance, review and improve accuracy of Front End Revenue Cycle which includes front end billing edits, front end denials, zero accounts and any other front end related revenue opportunity. Participate in and coordinate the implementation of strategies and processes. Participation and coordination of creation of payor update guides. Participate and create training manuals. Provide training and mentoring to new registrars on all shifts and current registrars in front end denial and edit findings. Identify and report ongoing issues and possible resolutions. Provide statistics to management. Responsible for presenting standard training programs, prepares course materials, establishes lesson plans and administers qualifying tests. Provides office support for all computer applications, office procedures and protocols. Run detailed statistics to determine what areas need improvement, where denials are happening, determine how to correct processes to prevent, bring information to denial meetings. Work with internal and external customers. Job Description Education/Training/Experience: BA or BS in related field preferred OR 3-5 years in Patient Access and/or Patient Accounting Experience. Strong verbal and written communication skills required. 1-3 years lead or supervisory experience preferred. Patient Registration, third party billing, precertification, insurance verification experience required. Working knowledge of registration and billing regulatory requirements including EMTALA. Ability to prioritize tasks. Excellent PC literacy skills required. Candidate must have a positive and strong work ethic. EPIC AND CERNER EXPERIENCE STRONGLY PREFERRED Work Shift Rotating (United States of America) Worker Sub Type Regular Employee Entity Albert Einstein Medical Center Primary Location Address 559 W. Germantown Pike, East Norriton, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here

OVERALL RESPONSIBILITIES: Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts. DUTIES: • Responsible and accountable for on-time submission and accuracy of regulatory reports • Review and complete determination associated Medical Device Report and/or Vigilance Report • Knowledge of and familiarity with global regulations for reporting • Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events • Interact positively with internal, external business partners and colleagues • Adhere and comply to work instructions, standard operating procedures, and regulations • Expedite investigations by collaborating with internal/external business partners • Achieve productivity targets • Fully trained within three months of hire • Achieve accuracy targets for complaint documentations • Participate in projects and events • Complaint determination • Reportability assessments • Conduct follow-ups with complainant, reporters • Checking your own work • Updating SharePoint • Tracking complaints in the process for closure • All other duties as assigned Qualifications • Bachelor's Degree or equivalent experience • Generally requires 2-4 years of related work experience • RAC or ASQ certifications a plus Additional Information All your information will be kept confidential according to EEO guidelines.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Schedule: Wed-Sat, 2 nd Shift Key Responsibilities Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process. Support manufacturing activities for cGMP compliance through spot checks/internal audits. Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues. Review of all documentation, in accordance with Good Documentation Practices (GDP). Review, revise, or draft Standard Operating Procedures (SOPs) Support processes that include aseptic process simulations, Commercial & clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised. Support batch review & material release in SAP for In-house reagents. Support Floor Spot-check, audit trail review. Strive to reduce non-conformances in supported areas by proactively driving compliance. Support Investigations team by providing quality and compliance input for continuous improvement and remediations. Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor. Utilize multiple electronic quality systems, batch records and SAP. Work in a team based, cross-functional environment to complete tasks required to meet business objectives. Must be able to aseptically gown to Support Grade B Clean rooms / practice aseptic behavior in controlled areas. Provide QA shop floor support for extended periods of time. Responsibilities will include but not limited to tasks mentioned above. Support regulatory inspections and audits as needed. Consistently perform tasks in adherence with safety policies, quality systems, and cGMP requirements, as well as according to state and federal regulatory requirements. Other duties will be assigned, as the need arises. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals. Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses Color Perception both eyes 5 slides out of 8. Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain and Planning Requirements Bachelors degree required in Life Sciences or Engineering. 0-2+ years Biotech/Pharmaceutical experience or equivalent industry experience Must have relevant working experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, technical operations or cell therapy. Experience with quality support in clinical manufacture is preferred. Flexible to work on weekends, as needed. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; climb, bend and stoop; and reach with hands and arms. Ability to lift 20 lbs. Report to work on-time. Duties are required to be performed on-site at manufacturing facility. Perform other duties as assigned. Attend departmental and other scheduled meetings. Practice good interpersonal and communication skills. Demonstrate positive team-oriented approach in the daily execution of procedures. Promote and work within a team environment. Learn new skills, procedures and processes as assigned by management and continue to develop professionally. Support and contributes to projects. Assist in troubleshooting issues related to manufacturing. Technical knowledge within functional units Demonstrate an understanding of the process in order to properly perform the assigned tasks. Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems. Utilizes tools within MS Office and other systems to improve business effectiveness. Read and interpret documents such as safety rules, operating instructions, and logbooks. Review and provide feedback for SOPs. Interpret a variety of instructions furnished in written, oral, or diagram. Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply chain process. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals, Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. #LI-BG1 #LI-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$75,972-$99,713 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. Legend Biotech maintains a drug-free workplace.