Quality Assurance Specialist jobs at AstraZeneca

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: Onboarding Specialist This Is What You'll Do: Plan and coordinate the logistics of new employee onboarding, including scheduling and preparing materials. Conduct orientation sessions to introduce new hires to the company's culture, values, policies and procedures. Schedule and coordinate onboarding activities, providing guidance and support to new hires throughout the process. Ensuring completion of paperwork and following all legal and administrative compliance when onboarding candidates. Assist new hires with completing the necessary paperwork, including employee forms, benefits enrolment, and IT setup. Processes I-9 and E-Verify requests. Processes background checks and drug screens. This Is Who You Are: Excellent interpersonal skills, strong written and verbal communication skills. Highly ambitious and ability to think outside of the box. Eager to share new ideas and contribute to a team. Self-motivated and willing to assume the initiative. Attentive to every detail. Capable of thriving while working independently. This Is What It Takes: 2+ years of experience in onboarding and recruitment with a proven track record of successful onboarding processes and employee retention. Strong knowledge of onboarding best practices, HR policies and procedures, and employment laws and regulations to ensure compliance during the onboarding process. Strong organizational skills to manage and streamline the onboarding process efficiently. Excellent communication and interpersonal skills to build rapport with new employees and establish a positive onboarding experience. Attention to detail and organizational skills to coordinate and manage multiple onboarding processes simultaneously. Adaptability and flexibility to accommodate the diverse needs and backgrounds of new employees. Ability to collaborate and work effectively with remote team members with prior experience in corporate onboarding. Proficiency in Microsoft Office Suite. Proficiency in using HRIS systems and experience with different applicant tracking systems. May require travel to assist field locations with recruitment. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. INNER SATISFACTION. OUTSTANDING IMPACT.

Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Columbus Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company's mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Board's direction). Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. Actively seek and lead projects to streamline processes, procedures, and/or practices. Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications Lead Auditor certified (ISO 13485) preferred Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 Training in or good working knowledge of root cause analysis tools Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc…) Advanced PowerPoint skills (i.e. Excel chart linking and template design) Effective technical writing and verbal communication skills. Experience Minimum three years in the medical device industry Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination Minimum two years experience as lead auditor Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

As a QA Specialist, you will work on projects related to proprietary implants, instrumentation, and design automation systems to enable personalized surgery. The Quality Assurance department encompasses activities related to Documentation Control, Change Control, Corrective Action and Preventive Action, eQMS Administration, Field Actions, Internal Audits and Third-Pary Audits, and Quality Metrics. In this capacity, the QA Specialist will work with a significant degree of independence and self-direction to ensure the establishment, implementation, and verification of companywide QMS systems for regulatory compliance. Responsibilities Plan agenda and lead CAPA meetings (present requests, take meeting minutes, and take actions per Boards direction). Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals). Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness. Assess previous audit findings to establish priorities and strategies. Plan annual audit schedule, determine and assign SMEs to audits, establish audit content, and allocate time. Prepare audit plans, perform audits (assess objective evidence to determine conformity to requirements, including ranking the levels of nonconformance findings), and complete audit reports. Support customer and regulatory audits, including audit response follow-up. Specifically, reserve meeting space, coordinate SME participation per audit agenda, documenting the audit, document and record retrieval and preparation, and submission of audit response. Stay up to date on industry standards and regulatory changes. Interpret standards and regulatory rules or rule changes, perform gap assessments between corporate procedures and applicable standards and regulatory rules, and implement them through the release or revision of corporate procedures. Actively seek and lead projects to streamline processes, procedures, and/or practices. Supports Field Action, which includes managing customer notification, product documentation, and follow-up activities to support closure of Field Action/Recalls. Monitor, gather, analyze, and trend key quality and compliance performance indicators utilizing pivot tables, charts, and graphs. Prepare presentations of trend data for quarterly trend and management review meetings. Coordinate quarterly trend and management review (schedule, document notes and attendance, and documentation archiving). Qualifications Lead Auditor certified (ISO 13485) preferred Training in or good working knowledge of 21CFR820, ISO 13485, MDSAP, and ISO 14971 Training in or good working knowledge of root cause analysis tools Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc) Advanced PowerPoint skills (i.e. Excel chart linking and template design) Effective technical writing and verbal communication skills. Experience Minimum three years in the medical device industry Minimum three years of experience in quality system management/quality assurance o CAPA (Corrective Action Preventive Action) administration; o Interpreting and implementing regulatory and standard requirements; o Reviewing system changes for continued compliance; o Monitoring, gathering, analyzing, and trending key quality and compliance performance indicators; and o Third party audit coordination Minimum two years experience as lead auditor Proven ability to support and implement quality systems and quality improvements (i.e. Upgrade from ISO 13485 2003 to ISO 13485 2016, or implementation of MDSAP). Increasing responsibilities whether within the same organization or as a progression within career path. Equal Opportunity Employer Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know. Compensation We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected starting pay range is: $80,000 to $90,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release. Work schedule: Sunday - Thursday 10:00pm - 6:30am JOB QUALIFICATIONS: High School diploma or GED required; higher learning certifications in an area relevant to role preferred. Minimum one (1) year of experience in a FDA-regulated manufacturing facility. Ability to read and interpret documents in English. Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria. Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred. Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines. Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands. Ability to work both independently and as a member of a team. Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums. POSITION RESPONSIBILITIES : Maintain professional, respectful and positive work environment. Practice acute attention to detail, high level of organization, and error-free performance in all tasks while supporting a fast-paced environment and adapting to changing priorities to meet operations demands. Generate controlled documents (e.g., logbooks, bulk compounding batch records, finished good batch records) for issuance using the Warehouse Management System (i.e., Oracle) and/or Quality Management System (i.e., Agile) as per the current production schedule and/or requests. Document transactions related to controlled document issuance, remittance, review, and release in shared logbooks and trackers as required. Document metrics related to processing batch records for release in shared tracker as required. Communicate with other departments regarding document control activities to ensure timely completion of tasks to support operations and release of finished goods. Review controlled documents (primarily batch records) returned/submitted to Document Control for completeness and correctness to ensure compliance with internal and regulatory criteria; facilitate resolution of observations (e.g., corrections) before release of finished goods and archival of documents. Place and remove product on QA hold when required; ensure Quality Events are resolved and verify disposition to manage bulk and finished goods accordingly. Change product status and close jobs in Warehouse Management System for release of finished goods. Upload required documents (e.g., batch records, customer-required documents) to appropriate shared file locations as required. Maintain the filing system for controlled document archival and destruction as per standard processes; retrieve controlled documents as requested for inspection. Assist with batch-related investigations as requested. Responsible for training employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category. Other reasonable business-related duties as necessary. PHYSICAL REQUIREMENTS: Ability to lift up to 25 pounds. Adequate vision to read controlled documents accurately. BENEFITS: PLD is a proud equal opportunity employer offering many corporate benefits, including: • Medical and Dental Benefits • 401K wirh employer match • Group Life Insurance • Flex Spending Accounts • Paid Time Off and Paid Holidays • Tuition Assistance • Corporate Discount Program • Opportunities to Flourish Within the Company PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #HP1

Job title: QA Specialist Department Division/Location: FLSA Status Quality Assurance Ontario, CA , USA Non-Exempt Position Reports To: Effective Date of Job description: Alternate Lourdes Gonzalez 7-16-2020 Lourdes Gonzalez POSITION SUMMARY A Quality Assurance Specialist performs any kind of testing and validation that will ensure food safety. The tasks will include support project efforts. This position will involves constant improvement of the operations processes. It will also operate as a member of the cross-departmental teams and projects if necessary. EDUCATION Elementary/Some High School High School/GED Post Secondary Education Bachelor's Degree/Master's Required Preferred Required Preferred Required Preferred Required Preferred Certifications: SQF Practitioner HACCP Required Preferred Required Preferred Required Preferred EXPERIENCE Years: 2-5 Special Focus of: Food Manufacturing SKILLS REQUIRED Detail-oriented individuals with analytical minds and strong communication skills. This position should demonstrate the following: Technical Skills - Understanding quality assurance as well as production technologies and systems is crucial in this role Computer Skills - Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations Commercial Awareness - These specialists should be experts in industry standards impacting inspection and quality control techniques and procedures Communication Skills - Strong oral and written communication skills for making presentations and producing testing and quality assurance reports is necessary. Attention to Detail - The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details. Team-Oriented - QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel Analytical Skills - Analyzing production processes and applying this skill to the inspection of products is central to this role Time Management - produce results in a timely manner. PRIMARY RESPONSABILITIES Deviation Analysis Support the analysis and corrective action of deviation that may come from process deviation, complaints, holds, etc. using root cause analysis techniques. Product and Raw Material Testing Support qualification of new product, raw materials and suppliers. Perform inspection on raw material and/or finished goods to check for defects and other product parameters to validate Plant internal programs and processes. Equipment Commissioning Support all tests related to new equipment commissioning and prepare report for further review. Process Validation Support validation plans for Plant's processes. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare detailed reports based on results of validation and qualification tests. Collect and analyze production samples to support process validations. Analyze quality control test results and provide feedback and interpretation to production management or staff. Performs audits of the effectiveness of development processes and products and recommends improvements as necessary Work with upper Management to identify performance improvement opportunities by analyzing quality data and documentation. Documenting/Recording Information Entering data in the QA drive to maintaining information in electronic form to facilitate data analysis. Operations Procedures Support the development of new procedures for Operations that will improvements and/or minimize errors and defects in product. Support operations processes standardization. Continuous Improvement Download quality and production information form Aptean system and perform monthly reviews and targets. Support and/or develop QA test trends and as need. Training Support Plant training program by creating training material for Quality and Production and consequently employee training. Safety Participate in, and support all safety program elements, directed towards meeting the plant's TIR (Total Incident Rate) goal established each year. This includes safety training, inspections, incident investigations, incentive programs, and any other safety-related activities. Comply with all company policies and procedures including safety rules. Food Safety and Quality Adheres to all Food Safety/Quality SOP's Communicates any known or suspected Food Safety/ Quality issues to the Production Manager or Supervisor, Q.A. Department or Management. Attends Food Safety/Quality training sessions.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Quality Assurance Specialist II reporting to the Senior Manager Quality Assurance of Cell Quality Operations in Morrisville, NC. This role requires independent work on site on 2-2-3 shift to support GMP operations on alternating shifts (Sunday - Thursday 7:00 AM to 7:00 PM and Friday - Saturday 7:00 - 5:00PM) that includes weekends on a rotating basis, as the manufacturing process is a 7-day process. This role requires frequent work in cleanroom environments and a strong understanding of aseptic techniques and compliance standards. A successful candidate will have relevant experience in early stage and/or commercial cell-based products manufacturing, shop floor support in an aseptic manufacturing environment. The Quality team at Sumitomo Pharma America, Inc. takes pride in leading compliant and innovative approaches to the development and commercialization of life-saving therapies. The Quality Assurance (QA) Specialist II will be a key member of our growing Quality Operations team, and support the Quality Systems, Quality Control and Quality Compliance functions. The ideal candidate is dedicated to excellence, passionate, adaptable, innovative, and eager to work in a collaborative environment. This candidate will be an integral member of a growing Quality team and work closely with our cross-functional development team and external partners. Critical responsibilities include ensuring compliance with regulatory requirements, company procedures, and supporting the build-out and continuing maintenance of our regenerative medicine manufacturing facility. This candidate must have demonstrated success in a quality role(s) in the pharmaceutical or biologics industry. Job Duties and Responsibilities * Provide Quality and Compliance oversight during aseptic manufacturing operations for manufacturing commercial and investigational products through Shop Floor presence. * Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures. * Experienced in aseptic operations within isolators, incubators, and biosafety cabinets (BSC), with knowledge in sterilization and decontamination cycles * Responsible for providing QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures. * Lead or participate in investigations and improvement activities and experience using tools, such as - 5 whys, Fishbone analysis. * Review and verify maintenance and calibration records in BMRAM and collaborate with engineering and maintenance teams to resolve discrepancies. * Ensure isolator operations are performed in compliance with validated procedures and aseptic techniques. * Advise and direct on the interpretation and implementation of regulations, guidelines, company procedures, and standards for the SMPA Quality Management System. * Ensure a state of inspection readiness at our internal manufacturing facility; provide Quality support and audit management during Agency inspections. * Support the SMPA Quality Management System, including but not limited to processes for Document Management, Deviations, CAPA, Change Control, Complaints, Management Review, Validation and Data Integrity. * Performing inspection and disposition of raw materials and components by supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures. * Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner. * Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas. * Conduct routine walkthroughs and detailed inspections of cleanroom areas to ensure compliance with GMP standards, identify potential contamination risks, verify proper gowning and material flow practices, and support continuous improvement of aseptic conditions Key Core Competencies * Strong leadership skills * Ability to work independently on shift and with cross functional teams * Must be able to pass cleanroom gowning and aseptic technique qualification. * Ability to work in cleanroom suit for extended periods. * Flexibility to support off-shift or weekend operations as needed. * High degree of organizational awareness, ability to connect the dots to understand interdependencies. * Demonstrate honesty in all aspects of the role, and a commitment to compliance and respectful conduct. Education and Experience * B.S. in chemistry, biological or pharmaceutical sciences, or related discipline is required. * At least 2-5 years of industry experience in the biotech/pharmaceutical industry with focus on Quality/Manufacturing. * Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents. * Experience in tissue and cell-based product manufacturing and aseptic techniques. * Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry. * Proficiency in systems including KNEAT, Veeva, SAP, SlingShot, and BMRAM is highly desirable. The base salary range for this role is $83,800 to $104,700. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

SummaryJob Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. JOB OVERVIEW The QA Technical Specialist is responsible for providing sterilization technical support for the sterilization group in conducting the validation activities for all BD Business Units whose product is sterilized by BD Interventional Sterilization as required. The QA Technical Specialist will support technical QA projects with execution and protocol/report writing as assigned. This position will support the routine monitoring equipment for EO Environmental programs and provide technical oversight of the equipment calibration program and document control in the Madison facility. This position will assist in review and assembling of sterilization DHRs for product release when necessary. ESSENTIAL DUTIES AND Responsibilities including the following. Other duties may be assigned. Support BD facilities / Business Units in sterilization validations and product launch activities by providing monitoring equipment and technical support. Maintains calibration and routine maintenance of the validation temp/RH monitoring equipment. Ensures compliance to divisional, Corporate, ISO, and EN requirements. Provides technical support for routine EO environmental safety programs including personnel monitoring and facility Baseline system. Writes all applicable protocols, reports, and procedures to support the QA technical applications to include Rotronics and QA projects as assigned. Assist QA Management in performing failure investigations. Revise and/or develop SOPs to support sterilization program. Support cost savings programs. Verifies DHR documents for accuracy and completeness prior to product release, when necessary. 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. Must possess the ability to work independently. Must be detailed oriented. Must possess knowledge about the physical, chemical, and biological sciences. Must understand impact of environmental control, packaging, and manufacturing process on sterility assurance. Thorough understanding of EO sterilization/validation. Have an understanding of process and equipment validation methodology with technical writing skills. Must be current on government regulations and international regulations regarding the sterilization of medical devices. Knowledge of hazardous chemical awareness. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Microsoft Word, Excel, and Access. Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building. Forklift experience is preferred EDUCATION and/or EXPERIENCE High School graduate (Associates or Bachelor's degree preferred) Preferred three years of experience in medical device or GMP regulated environment with process validation of medical devices, pharmaceuticals or biologics. LANGUAGE SKILLS Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures. Ability to communicate ideas articulately. MATHEMATICAL SKILLS Ability to apply mathematical concepts such as algebra, calculus, and statistics. REASONING ABILITY Ability to effectively manage day to day decisions concerning sterilization projects. Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Judgment is essential. Determining what is absolutely vital and ensuring compliance with limited parameters is imperative. A high level of initiative is required. Day-to-day decisions about projects and validation programs are made frequently. Position will collaborate with internal and other division employees, contractors, and· regulatory agencies. PHYSICAL DEMANDS This position entails regular sitting, object manipulation, sensing, arm extension, and verbal communication. Standing and walking are regular activities for the employee. The employee is required to climb or balance and stoop, kneel, crouch or crawl. Must be capable of lifting at least 25 pounds. Specific vision abilities required by this job include close vision and distance vision. WORK ENVIRONMENT This position works in a normal office environment. The noise level in the work environment is quiet to moderate. Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit ********************** Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. #earlycareer Required Skills Optional Skills . Primary Work LocationUSA GA - MadisonAdditional LocationsUSA GA - Covington BMDWork Shift

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. * Ensure deviation timelines are maintained through inter-department communication. * Facilitate and lead assigned investigations involving multiple investigation areas. * Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. * Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). * Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). * Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. * Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. * Under supervision assist with documentation for the closure of complaint investigations. * Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audits and inspections as required. * Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current in ISO train. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and 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. * Bachelor's degree in a science or engineering field. * ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. * Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * Ability to apply critical thinking to scientific problems and demonstrated knowledge. * Ability to apply statistical quality management concepts. * PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. * Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Under supervision, assist with documentation for the closure of investigations. * Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. * Scheduling departmental meetings, maintaining meeting minutes and attendance. * Maintain departmental records and files (both electronic and manual). * Participate in cross-functional project teams as required. * Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. * Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). * Keep training curriculum current. * Ensure all work is performed and documented in accordance with existing company policies and procedures. * Perform any other tasks/duties as assigned by management. Education Requirements and 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. * High School or GED diploma required. Associate's degree or equivalent years of experience preferred. * Experience working in a Quality role within a cGMP manufacturing environment required. * Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. * Strong attention to detail, adherence to SOPs. * Ability to work effectively in a collaborative environment. * Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. * Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. * PC Skills Required (MS Word, Excel). * Ability to work overtime as needed. Physical Environment and Requirements * Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and 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. Bachelor's degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with the internal audit program. Interacts with all levels of the organization and maintains on-going dialogue with management. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Under supervision, assist with documentation for the closure of investigations. Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections. Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current. Ensure all work is performed and documented in accordance with existing company policies and procedures. Perform any other tasks/duties as assigned by management. Education Requirements and 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. High School or GED diploma required. Associate's degree or equivalent years of experience preferred. Experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. PC Skills Required (MS Word, Excel). Ability to work overtime as needed. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary Range: $70,100 - $85,000 The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 8:30 AM - 5 PM KEY RESPONSIBILITIES Batch Review and disposition: Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. Review and approve Master Batch Records. Perform the review of records and determine disposition of: Medical Devices Packaged/Labeled Medical Devices Clinical Product Investigations and CAPAs. Perform the review of Testing Specifications. Validation Coordinate and monitor validation activities. Provide support during regulatory inspections of GMP Contractors and LCI facilities. Assist in performing inspection readiness activities. Review Quality Agreements. Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. Provide updates to Manager, BioMed Operations. QUALIFICATIONS Bachelor's Degree in a life science-related discipline or equivalent work experience. Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers. Knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. Ability to exercise strong risk-based business judgment. Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally Good investigation and monitoring skills. Current knowledge of QC testing methods. Attention to detail and implementation of good documentation and GMP processes is essential. Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. Why LCI? Purpose-driven company driven by principles, not profit Reach your highest potential: upward mobility, rewarded through hard work Competitive salary and compensation Basic Life Insurance at no cost to the employee 401(k) with match and Surplus-Sharing Plans Health, Dental, and Vision Insurance Ten paid holidays annually Paid Time Off (PTO) On-site Health and Wellness program Employee Assistance Program (EAP)

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA. Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system and CAPA program. To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence. Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems. Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions. Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coaches lead investigators on technical writing. Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures. Supports and initiates deviations, trends, or other technical investigations, as applicable. Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding. Effective implementation of electronic Quality Management system (eQMS) across organizations. To perform additional duties assigned by the reporting manager. Qualifications: Education/Experience: Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1-3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities: Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements: Legally authorized to be employed in the United States Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $25.0 per hour to annual salary of $70,000 Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

As a Quality Assurance Validation Specialist is responsible for validating/qualifying equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. This role is responsible for reviewing, revising and approving qualification/validation protocols and reports (e.g. facilities, processes, and equipment). Collaborates cross-functionally to support required on-going compliance activities Support continuous improvement activities and fostering of quality mindset. Job Responsibilities: • Support Tergus Pharma through the establishment of validation/qualification programs across disciplines • Ensure alignment with industry standards in accordance with the relevant product's lifecycle. • Responsible for guidance and quality review/approval of internal protocols and reports related to these activities will encompassing IND-enabling, pre-clinical, clinical and commercial projects: • Process manufacturing equipment qualification • Cleaning validation • Analytical instrument qualification and associated laboratory computer systems validation • Internal technology transfer • Owns, leads and/or supports multidisciplinary multi-site, moderate to complex projects. Qualifications: • BS or MS degree in Engineering, Biochemistry or related field required. • 5+ years of experience in the biopharmaceutical industry with strong technical understanding of production process from clinical phases through commercialization. • Expertise in support of analytical laboratory instrumentation and equipment qualification • Thorough knowledge and experience with technology transfer projects and the change control process. • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning validation, and equipment validation. • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization. • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project. • Ability to travel approximately 10% • Experience within a multi-product facility is a plus • Experience using risk based approaches (FMEA, PHA, etc.) and a strong analytical ability. • Experience supporting internal regulatory and partner inspections. • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision. • Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.

QA Specialist IV - Raw Materials Join our Quality Assurance team and play a key role in ensuring compliance and operational support for the raw material lifecycle. Your expertise will help us maintain the highest standards in GMP and quality culture. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental, and vision insurance. Our full list of global benefits can be found here: *************************************** What you will do: Manage SAP transactions to support raw material lifecycle and ensure timely release for production. Provide on-the-floor support for raw material requests and identify process improvements. Review and approve material documents for disposition to support timely release. Approve SOPs, work instructions, and validation documents relevant to raw material lifecycle. Review and approve quality records such as investigations, CAPAs, and change controls. Collaborate with Supply Chain, Quality Control, and Manufacturing to resolve issues. Apply data integrity principles and maintain GMP compliance in all activities. What we are looking for: Bachelor's degree in Life Sciences or related field (or equivalent experience). 5-10 years of experience in Quality Assurance within GMP environments. Strong knowledge of GMP regulations and compliance requirements. Experience with SAP, TrackWise, and document management systems. Excellent communication and problem-solving skills. Ability to work independently and lead complex issue resolution. Biotechnology manufacturing experience preferred. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.