Quality assurance manager jobs in Phillipsburg, NJ - 129 jobs

🧪 Quality Assurance Operations Supervisor | Bethlehem, PA Join a well-established, FDA-regulated pharmaceutical manufacturing site in Bethlehem, PA that produces acute care drug products used in hospitals worldwide. This team is known for its strong quality culture, long-term stability, and investment in people. Competitive salary, bonus eligibility, and excellent benefits starting day one! 🔍 Job Summary The Quality Assurance Operations Supervisor oversees GMP quality activities supporting manufacturing and packaging operations. This role plays a critical part in batch record review and disposition, deviations and CAPAs, OOS investigations, QC data review, and drug product complaint management to ensure regulatory compliance and product quality. 🛠 Key Responsibilities Coordinate batch documentation review with manufacturing and packaging teams to support timely product release. Ensure API and drug product batches comply with GMP and regulatory requirements. Supervise daily activities of the QA Operations team. Mentor and coach team members while supporting succession planning. Review production and QC documentation prior to batch disposition. Ensure deviations, data integrity issues, and errors are investigated per internal procedures. Oversee QC data review and OOS investigations. Perform documented QA walkthroughs of manufacturing and packaging operations. Collaborate with global QA partners to support batch release activities. Manage the drug product complaint program, including investigations and reporting. Prepare QA metrics for weekly, monthly, and quarterly management meetings. ✅ Skills & Competencies Strong risk-based decision-making and critical thinking skills Ability to evaluate quality issues using GMP knowledge and data analysis High attention to detail with a proactive sense of urgency Strong customer service mindset and professional communication style Excellent written and verbal communication skills Motivated, energetic, and people-focused leadership approach 🎓 Education / Experience Bachelor's degree preferred or equivalent experience 10+ years of pharmaceutical or biotech industry experience Experience with QMS tools such as TrackWise, EDMS, LMS, or similar Working knowledge of 21 CFR Parts 210, 211, and Part 11; Part 820 familiarity preferred.

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

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: - *********************************************

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

We are currently on a hunt for a Quality Manager to join our client's team in Bethlehem, PA. What you'll be doing: You will lead the overall quality direction of this World Wide Food company and will be involved in every aspect of overseeing quality. Will lead the development and execution of all Quality Assurance programs and activities that ensure compliance with company policies, food safety standards, government regulations, and industry best practices including GMP, SQF and HACCP. Will edit and develop HACCP plans and strategies for new products. Maintain current library for all GMPs, SOPs, SQF. Qualifications We would love to hear from you if : 4+ years of experience in QA food processing and packaging experience. You must have SQF experience. BS/Masters in Food Science, Microbiology, engineering Must have extensive experience with FDA. PS:Excellent Base Pay + Great Benefits + Relocation Pay. We embrace diversity and equal opportunity in a serious way. Additional Information All your information will be kept confidential according to EEO guidelines.

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

**General Description:** Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory. **Essential Functions of the job:** + Lead the QC Biochemistry GMP laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc. + Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required. + Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. + Undertake any other duties as required. **Core** **Competencies** **, Knowledge, and Skill Requirements:** + Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related). + Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required. + Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical and problem-solving ability. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. **Supervisory Responsibilities:** + Supervise a highly efficient QC Biochemistry team. Identify and develop key talents. + Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc. + Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports. + Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Manage, motivate, coach and mentor direct reports. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time. **Education Required:** Bachelor's Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required. Master's degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred. **Travel:** + Must be willing to travel approximately 10%. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

+ The ideal candidate will have 5+ years of QA experience specifically involving raw materials in a GMP-regulated environment such as pharmaceutical, biotech, or other life sciences industries. + A bachelor's degree is strongly preferred; master's candidates may be considered. + This role is physically active and requires passing an eye exam, lifting materials (~40 lbs), and consistent gowning (jumpsuit, scrubs, goggles). + Strong attention to detail, comfort in a warehouse environment, and GMP compliance experience are essential. **Responsibilities:** + Ensure that all operations comply with relevant regulations and requirements, including Safety, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Documentation Practices + Conduct sampling and inspection of incoming raw materials, assess documentation, and determine disposition + Compile and review documentation associated with receipt, storage, incoming inspection, and distribution + Perform routine Quality Assurance assessments and provide direct operational oversight + Provide expert advice on quality matters to operational teams and cross-functional groups + Ensure staff complete necessary training related to client's business operations + Approve GMP processes, procedures, documents, and records, addressing deviations, CAPAs, change controls, risk assessments, and validation records as required + Achieve established metric targets and develop standardized approaches for tracking progress + Collaborate with Logistic Service Providers (LSPs) to maintain service levels and identify areas for performance enhancement + Represent the Quality Unit during audits and inspections, directly interacting with regulatory agencies + Support internal and external audits and inspections as a member of the audit/inspection team + Perform additional duties as assigned by management **Preferred Qualifications:** + Proven ability to communicate effectively with cross-functional teams and diverse cultures, both verbally and in writing + Academic background in Life Sciences, Physical Sciences, Applied Engineering, or Manufacturing Technologies + Prior experience overseeing QA in distribution, warehousing, manufacturing, validation, and engineering functions + Expertise in managing deviations, change controls, and CAPAs + Proficiency in Veeva, SM LIMS, and ERP systems + Knowledge of industry standards (GMP, GDP, Import/Export) + Commitment to exemplifying client's core values + Demonstrated self-leadership and motivation + Strong strategic thinking skills + Ability to evaluate compliance issues and engage with regulatory inspectors + Experience managing multiple priorities within a dynamic environment + Direct experience with drug substances and/or drug products + Advanced problem-solving abilities and capacity for scientific, risk-based decision-making + Track record of representing an organization during regulatory interactions + High proficiency in Microsoft Excel, Word, and PowerPoint. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

Job Description The Quality Assurance Specialist (QA Specialist) will support quality operations, reporting to the CRM Administrator. This position will be expected to have significant knowledge of the phone and incident management systems to support data loads, system changes, training, and quality audits. The ideal candidate will assist in the development of standard operating processes. This is a non-exempt position, eligible for overtime. A typical day in the life of a QA Specialist: Perform call quality audits utilizing the call auditing software. Assist with ticket/issue auditing. Serve as backup for the CRM Administrator. Troubleshoot and report any system issues such as outages to the service providers for resolution. Manage requests from stakeholders for changes/enhancements to the call and incident management systems. Assist the CRM Administrator in managing the sprint tracker (project tracker). Perform testing on systems as needed and as changes/enhancements are released. Communicate changes to end users. Identify, analyze, and document defects, questionable functions, errors, and inconsistencies in software program functions, outputs, online screens and content.. Assist with monitoring program performance after implementation to prevent recurrence of program operating problems and to ensure efficiency of operation. Oversee creation and contribute to development of user guides, articles, etc. Other duties as assigned. Assist in vendor and carrier negotiations by providing data-driven analysis. The skills you'll contribute to our diverse team: Bachelor's degree or equivalent work experience. Experience with Oracle Service Cloud and Five9 is preferred. Knowledge of quality auditing practices for call center operations is preferred Ability to analyze business and/or functional requirement documents for testing purposes. Strong analytical and problem-solving skills. Keen attention to detail. Ability to work on multiple projects under tight deadlines and changing priorities. Strong interpersonal and communication skills to cultivate positive working relationships. Ability to work within a team, and if needed, independently at a very fast paced environment Who are we? At SDI, we're proud to help essential organizations across North America compete more effectively in a challenging global marketplace - and keep our economy moving. We do this by thinking differently, questioning conventional wisdom, and constantly challenging the status quo. We're evolving the way leading manufacturers, multi-site retailers, and higher education think about their maintenance, repair, and operations (MRO) strategies - the critical supply chain of parts, materials, equipment, and consumables necessary to keep plants and facilities operating safely and productively. Every day, we help companies eliminate waste, minimize risk exposure, and stay competitive on an ever-changing world stage. Why work for SDI? The Philadelphia Inquirer named us a Top Workplace in 2023! Additionally, we pride ourselves on taking care of our employees. Here are some of the benefits we offer: Health insurance (medical, dental and vision). Training and development opportunities - 2023 winner of the People Accelerator award. Vacation, wellness days, pet bereavement days and 12 paid holidays. 401K with a company match. Tuition reimbursement. Student loan repayment assistance. Reimbursement for safety shoes. Discounted tickets to a variety of different vendors. The pay range for the role is $25.00 - $27.00 per hour. Individual pay depends on various factors, such as role level, relevant experience and skills, and location. Pay ranges are reviewed and typically updated each year. Offers are made within the pay range applicable at the time. EEO SDI is proud to be an equal opportunity employer committed to inclusion and diversity. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, or other applicable legally protected characteristics. If you have a disability or special need that requires accommodation for any part of the employment process, please let us know by contacting us at **********. SDI participates in the E-Verify program.

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 Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ. Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities 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 operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations. Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation. Assist in the development of process, operational, and quality improvements for manufacturing. Assist in the review and development of process-related protocols and documentation. Provide technical quality oversight for electronic batch records. Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems. Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities. Ability to work independently perform assigned tasks. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. May support CSV activities as needed. May support equipment qualification activities as needed. Drive continuous improvement. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required. 5+ years relevant work experience or equivalent. 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. A portion of the 5 years must include quality assurance experience. Strong knowledge of cell therapy processes strongly preferred. Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred. Experience with Computer System Validation (CSV) is a plus. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience reviewing/auditing GMP documentation. 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 escalate to management when required. Detail-oriented and able to 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. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The anticipated base pay range is$75,972-$99,713 USD Benefits We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating 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 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.

Title: Quality Assurance Compliance Technical Specialist Department: Quality Assurance Job Type: Regular Full Time Shift: Monday through Friday - 1st NMS Labs has developed an extensive menu of more than 2,500 Clinical and Forensic toxicology tests to support clients in healthcare, public health, and public safety fields. For over 50 years, our clients have relied on NMS Labs for unique testing solutions that demonstrate our company core values of Quality, Integrity, Service, Innovation and Engagement. As we work to increase the company's positive impact on the diverse markets we serve, we are seeking talented professionals to join us for the journey! We invite you to learn more about our company by visiting NMSLabs.com. Job Summary: Under limited supervision, the Quality Assurance Compliance Technical Specialist will assist in monitoring regulated work conducted at NMS Labs for compliance with study protocols, internal processes, procedures, company contracts, company quality standards, and company-controlled documents. This Quality Assurance Compliance Specialist will report directly to the Quality Assurance Compliance Supervisor and will be completely independent of any laboratory operations. Requirements: Bachelor's degree in a chemical, physical or biological science with a minimum of 3+ years diverse laboratory experience Or Master's degree in chemistry, physical or biological science with 1-year diverse laboratory experience 3 years' experience in QA auditing involvement. Preferred: Experience with leading a project. Major Duties and Responsibilities: Participate in activities designed to assure regulatory compliance with licensing/accrediting agencies such as personnel licenses (tracking and submission to agency), external proficiencies (tracking, data submission, data entry for grading), and/or document control within the compliance software. Perform scheduled internal audits at a frequency to assure compliance with applicable processes and procedures. Observe work practices and report any deviations from protocol, method, SOP, or regulations. Notify Supervisor and appropriate personnel of the audit findings by documenting the scope of audit and findings in a written report. Perform follow-up audits as necessary to verify that appropriate corrective action has been completed. Participates in Continuous Quality Improvement efforts. Approved to be a lead auditor in the NMS Labs Internal Audit Program. Writes reports of audit findings and makes recommendations to technical staff on corrective actions for findings. Participate in updates to the audit matrix and/or design and scheduling of internal audits. Reviews proficiency data prior to submission. Reviews and grades proficiency survey results and issues reports for management review. Assist project managers and testing supervisors (as needed) in setup and continuation of laboratory procedures in compliance with established laboratory processes and procedures. Attend professional meetings and/or conferences on QA activities and relay information gained to the QA group. Remains current in compliance trends for those areas of responsibility. Participates/presents in laboratory continuing education program as needed. Ensure that pertinent information is entered into and maintained in the appropriate QA files. Assists QA Regulatory with external audits/inspections, as applicable. Other duties as assigned. Knowledge, Skills, and Abilities: Ability to define and resolve problems, collect data, establish facts, and draw valid conclusions. Ability to read and audit complex technical data and procedures to determine compliance with established processes and procedures. Ability to make effective and persuasive speeches and presentations to peers and management for the purpose of effecting changes necessary for regulatory compliance. Ability to identify operationally efficient strategies to adhere to quality compliance requirements. Ability to effectively present information and respond to questions from all co-workers. Ability to effectively prioritize assignments to meet long and short-term deadlines. Strong organization, documentation skills, attention to detail, and able to prioritize assignments to meet deadlines. Possess good computer skills (to include Excel and Word) and internet usage. Ability to travel, including out of state. Maintains regular and reliable attendance. Physical Demands: Ability to talk, hear, stand, reach with hands and arms, and use hands and fingers to manipulate computer keyboard, objects, tools, or controls. Specific vision abilities (with correction) include close and distance vision. Walking and carrying objects from one work location to another and sitting and standing sometimes for periods of time. Offers of employment are made contingent upon a nationwide background investigation and urine drug screen with results satisfactory to standards of employment at NMS. We are an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, creed, sexual orientation, color, religion, sex, national origin, age, marital status, citizenship status, otherwise qualified disability, or protected veteran status (disabled Armed Forces Service medal, recently separated, active duty or campaign badge), domestic violence victim status, arrest record, or predisposing genetic characteristics.

🚨 Now Hiring: Quality Assurance Specialist 🚨 🔁 Contract-to-Direct Opportunity Local to Bethlehem, PA only 💰 $70-75K ❌ No C2C | No Sponsorship Join a fast growing Pharmaceutical Manufacturing site in a long-term contract role as a Quality Specialist. In this position, you'll play a vital role in driving compliance, elevating operational standards, and supporting the production of critical care products that impact patients worldwide! Job Summary: Strive to proactively drive the Quality culture at the site and promote cGMP activities. This person will work hands-on with the responsibility of ensuring compliance, improving practices, and qualifying/validating new processes with company strategic goals as a guide. The role may also serve as a liaison between the Operations group and the QA/QC department for day-to-day activities, capital projects, and process improvements. Essential Duties & Responsibilities Provide documentation and compliance support to meet Global Regulatory Requirements for licensed products. Partner with cross-functional departments to address GMP requirements in validation, investigations, complaints, procedure updates, and change control. Manage multiple priorities while providing leadership, guidance, and feedback to team members. Drive packaging OEE (Overall Equipment Effectiveness) initiatives. Support qualifications, deviations, customer complaints, investigations, and systems compliance. Maintain oversight of the PAS-X system and ensure 24/7 audit readiness. Support regulatory audits with thorough preparation and follow-through. Lead document control activities to ensure accuracy, consistency, and compliance. Education & Experience Bachelor's degree or higher in a scientific, quality assurance, or technical field. 1+ years of experience in the pharmaceutical or related regulated industry. Knowledge/understanding of cGMPs, regulatory standards, and industry best practices. Ability to assist in investigations, interpret regulations, and make sound quality decisions. Exceptional verbal and written communication skills with the ability to collaborate across departments and leadership levels. Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems. Strong problem-solving skills with the ability to lead projects and deliver timely results.

**General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Physicochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Physicochemistry laboratory. This position reports to the Senior Manager QC and is located full time at the Hopewell, NJ site. **Essential Functions of the Job:** + Lead the QC Physicochemistry laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards. + Manage QC Physicochemistry laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc. + Ensure Physicochemistry laboratory compliance with Environmental Health and Safety (EHS) standards. + Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations. + Review of laboratory test results, ensuring adherence to Good Documentation Practices. + Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures. + Implementation of effective corrective actions and preventive actions (CAPAs). + Participate in internal and external GMP audits where possible. + Ensure that the QC Physicochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives. + Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience. + Working knowledge and experience with physicochemistry analytical methods such as GC, HPLC, UPLC, IEF, TOC, UV, FTIR, etc. + Knowledgeable with USP/EP and cGMP/EU GMP regulations. + Familiar with instrument and equipment validation. + Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry. + Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. + Strong leadership/team management skills and experience. + Manage, motivate, coach and mentor direct reports. + Credible and confident communicator (written and verbal) at all levels. + Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment. + Excellent project management skills. + Hands-on approach, with a 'can do' attitude. + Ability to prioritize, demonstrating good time management skills. + Self-motivated, with the ability to work proactively using own initiative. + Committed to learning and development. + Interacts with all levels of BeOne employees + Undertake any other duties as required. **Supervisory Responsibilities:** + Manage direct reports from QC Physicochemistry laboratory. + 2+ years of managerial experience directly managing people required. + Leadership experience leading teams, projects, programs or directing the allocation of resources. **Computer Skills:** + Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). + Ability to work on a computer for extended periods of time **Travel:** Must be willing to travel approximately 10% **Education/Experience:** + Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. + Bachelor's in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred. + Master's degree and 4+ years of relative experience preferred. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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.