Post job

Quality assurance specialist jobs in Fayetteville, NC - 130 jobs

All
Quality Assurance Specialist
Quality Assurance Associate
Senior Associate Quality Assurance
Senior Quality Assurance Manager
Quality Systems Manager
  • Quality Assurance Specialist

    Planet Pharma 4.1company rating

    Quality assurance specialist job in Holly Springs, NC

    100% ONSITE 1 year contract This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects. • Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV). • Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight. • Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution. • Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors. • Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements. • Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation. o May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders. • Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required. • Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. • Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. • Participate in meetings related to document planning, execution, and issue resolution. • Escalate any compliance concerns or critical gaps to QA management. • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Basic Qualifications Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
    $52k-85k yearly est. 5d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Manager of Quality Management Systems

    Advanced Recruiting Partners

    Quality assurance specialist job in Garner, NC

    The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness. Essential Duties and Responsibilities Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards. Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs). Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments. Ensure timely vendor and customer qualification and verification activities. Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations. Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities. Review, approve, and authorize quality-related documents, records, and agreements. Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards. Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness. Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement. Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance. Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements. Train warehouse operations personnel on quality procedures and compliance expectations. Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices. Conduct annual reviews of SOPs and update processes as required. Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner. Work Experience Qualifications Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry. Results-oriented professional with a strong customer service mindset and effective communication skills. Experience with SAP and electronic QMS platforms preferred. High attention to detail with professional verbal and written communication skills. Ability to manage multiple priorities and projects simultaneously in a regulated environment. Willingness and ability to travel for audits, meetings, and industry events. Strong time management, organizational, and problem-solving skills. Self-motivated, accountable, and proactive in driving quality initiatives. Proficient in administrative tools, including MS Office and Google Workspace. Excellent written, verbal, and interpersonal communication skills. Masters is preferred.
    $67k-105k yearly est. 5d ago
  • Senior Quality Assurance Associate

    Infotree Global Solutions 4.1company rating

    Quality assurance specialist job in Holly Springs, NC

    Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Let's do this. Let's change the world. Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Client requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems. Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Basic Qualifications High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree Top 3 Must Have Skill Sets: Previous work on GMP Facilities PQA or Mfg preferably Drug Substance Experience Previous work with Batch records/Deviations/QA Oversight Nice to have: B.S. degree Day to Day Responsibilities: On the floor guidance/Mfg support Oversee compliance in execution Batch Record Review SOP review/Approvals Deviation Review Help Mfg Problem solve with Quality mindset
    $62k-79k yearly est. 5d ago
  • Senior Quality Assurance Associate

    Spectraforce 4.5company rating

    Quality assurance specialist job in Holly Springs, NC

    Job Title: Quality Assurance Senior Associate Duration: 12 Months Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Summary: Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Requirements: Previous work on GNP Facilities PQA or Mfg preferably Drug Substance Experience Previous work with Batch records/Deviations/Qa Oversight Nice to have: B.S. degree
    $68k-87k yearly est. 4d ago
  • Associate Quality Assurance Commercialization Specialist - Maxton

    Campbell Soup 4.3company rating

    Quality assurance specialist job in Maxton, NC

    Since 1869, we've connected people through food they love. We're proud to be stewards of amazing brands that people trust. Our portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Swanson, and V8. Here, you will make a difference every day. You will be supported to build a rewarding career with opportunities to grow, innovate and inspire. Make history with us. Why Campbell's… Benefits begin on day one and include medical, dental, short and long-term disability, AD&D, and life insurance (for individual, families, and domestic partners). Employees are eligible for our matching 401(k) plan and can enroll on the first day of employment with immediate vesting. Campbell's offers unlimited sick time along with paid time off and holiday pay. If in WHQ - free access to the fitness center. Access to on-site day care (operated by Bright Horizons) and company store. Giving back to the communities where our employees work and live is very important to Campbell's. Our “Campbell's Cares” program matches employee donations and/or volunteer activity up to $1,500 annually. Campbell's has a variety of Employee Resource Groups (ERGs) to support employees. How you will make history here... The QA Commercialization Specialist's primary role is assisting in the development and maintenance of formula and procedure systems. This includes responsibility for compliance to all company and regulatory policies/procedures pertaining to product safety/quality. The QA Commercialization Specialist will work with a cross functional commercialization team comprised of both corporate and plant functions to launch the manufacturing of new products at the plant. The candidate will have the hands-on opportunity to explore all quality areas of a food manufacturing plant including product realization, system and regulatory compliance, laboratory work, and grow into a technical resource for manufacturing, commercialization, and engineering. What you will do... 1. 40% - Assists with the implementation of all product formulas, procedures, and thermal process requirements including product startups, special batches, packaging trial and reformulation reviews, label compliance, and RMS administrator. 2. 30% - Supports the cross functional commercialization team in launching new products. 3. 15% - Actively participates in continuous improvement activities within systems and the plant. Uses various computer support systems for data manipulation, basic analysis and reports of product quality information. 4. 10% - Investigates and analyzes incidents and non-conformances, takes corrective action and/or makes recommendations as appropriate for routine incidents. Functions as QA representative on non-routine activities associated with project/team assignments which may include: specification development, quality design support, new product start-ups, training, instrument evaluation or method development, etc. Supports efforts to educate and train the workforce on food quality and safety programs. 5. 5% - Conduct pre-shipment reviews of food safety/quality records to assure regulatory compliance, including electronic record review and allow for timely release of product to meet customer service requirements. Conducts reviews and disposition of product requiring micro testing, container integrity evaluations, or Process Safety review/release. Who you will work with... Key working relationships that must be developed or maintained: Team working relationship with WHQ R&D, Quality Systems Technologist, operations and maintenance business unit leaders/team leaders. Establish and sustain effective relationships with all employees in order to foster an environment where innovation and cooperation are used to solve problems. What you bring to the table (Must Haves)... Bachelor's Degree 6 months years related experience in the food industry, microbiology or related field; internships/co-ops will be considered. It would be great if you have (Nice to Haves)... Preferred discipline in Food Science, Microbiology or related field High level of computer skills including electronic formula database, PLC, RMS, and working with Engineers to set up the plant floor automation for product processes. Strong leadership, interpersonal, communication and analytical skills. Ability to lead by involving others in decision processes. Ability to implement change, motivate others and encourage team development. Ability to manage multiple tasks and adjust priorities. Strong organization skills. Strong written communication skills. Detail Oriented Critical Thinking Skills Compensation and Benefits: The target base salary range for this full-time, salaried position is between $55,900-$80,400 Individual base pay depends on work location and additional factors such as experience, job-related skills, and relevant education or training. Total pay may include other forms of compensation. In addition, we offer competitive health, dental, 401k and wellness benefits beginning on the first day of employment. Please ask your Talent Acquisition Partner for more information about our total rewards package. The Company is committed to providing equal opportunity for employees and qualified applicants in all aspects of the employment relationship, including consideration for employment, without regard to race, color, sex, sexual orientation, gender identity, national origin, citizenship, marital status, protected veteran status, disability, age, religion, or any other classification protected by law.
    $55.9k-80.4k yearly Auto-Apply 48d ago
  • Specialist Quality Assurance

    Us Tech Solutions 4.4company rating

    Quality assurance specialist job in Holly Springs, NC

    This QA specialist will provide quality support and oversight of the commissioning & qualification and process qualification at with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem at and ongoing Automation support to the Manufacturing floor and expansion projects. **Key Responsibilities:** + Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV). + Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight. + Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution. + Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors. + Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements. + Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation. + May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders. + Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required. + Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. + Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. + Participate in meetings related to document planning, execution, and issue resolution. + Escalate any compliance concerns or critical gaps to QA management. + In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. **Basic Qualifications:** + Doctorate degree OR + Master degree and 3 years of experience OR + Bachelor degree and 5 years of experience OR + Associate degree and 10 years of experience OR + High school diploma / GED and 12 years of experience **Must Have Skill Sets:** + Previous experience in computer system validation (CSV) or quality oversite of CSV. + Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired. + Experience with computerized systems including troubleshooting, reliability, and performance improvements. **Day to Day Responsibilities:** + Will work with an established QAV team to support automation and DTI for the site and expansion projects. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
    $53k-96k yearly est. 7d ago
  • Sr. Manager - QA Assurance

    Eli Lilly and Company 4.6company rating

    Quality assurance specialist job in Parkton, NC

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Manager/Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours night-shift (2-2-3) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $94,500 - $138,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $94.5k-138.6k yearly Auto-Apply 16d ago
  • Specialist III, Quality Assurance Operations

    Kyowa Kirin North America

    Quality assurance specialist job in Sanford, NC

    Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Quality Assurance Operations Specialist III plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin's new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products. You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin's Quality Management System. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies. Key responsibilities include executing core QA activities such as batch record review, product disposition, and oversight of warehouse, laboratory, and supplier operations. You will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System in Veeva, you will ensure alignment with regulatory requirements, including data integrity standards. Through active participation in regulatory inspections and leadership in quality culture initiatives, you will help ensure the site operates with excellence, integrity, and accountability. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization's values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts. This role reports to the Senior Manager, Quality Assurance Technical Skills, Knowledge, and Experience • Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met. • Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance. • Participate in batch disposition and support final product release by verifying documentation and quality standards to enable timely and compliant delivery. • Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements. • Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and alignment with regulatory and quality standards. • Identify and escalate discrepancies or non-compliant entries within the Quality Management System (Veeva), collaborating with process owners to resolve issues and ensure records meet regulatory and internal standards. • Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate CAPAs and communicate resolution plans to drive effective compliance. • Conduct Supplier Quality activities including onboarding, monitoring, and recertification to maintain alignment with internal and external quality standards. • Partner with Quality Control to ensure laboratory operations meet cGMP standards and support consistent, high-quality testing practices. • Monitor and analyze site quality metrics-including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, EM data trends, Stability Trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance. • Maintain site Quality Management System procedures within Veeva, leveraging the global QMS structure to ensure consistency and regulatory alignment. • Champion a culture of quality in all GxP areas within the Site Operations by providing subject matter expertise focused on patient-centric practices, sustainable compliance, and inspection readiness. • Participate in regulatory inspections by demonstrating site compliance and contributing to Quality Assurance activities. • Develop, monitor, and communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability. • Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records, including 21 CFR Part 11. Individual contributor, with responsibility to lead or work with cross-functional project teams. Education • Bachelor's degree in Life Sciences, Chemical Engineering, Pharmaceutical Sciences, Quality Assurance, or a related discipline required. • Advanced degree (e.g., Master's in Regulatory Affairs, Biotechnology, or Quality Systems) preferred. Experience • Demonstrate 3-5 years of experience in Quality Assurance within biopharmaceutical manufacturing, executing technical and compliance activities across GMP QA functions including Document Control, Training, Inspections, Batch Disposition, Shop Floor QA, Laboratory QA, Vendor Qualification, and Incoming Quality Assurance. • Assisted with QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards. • Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and ensure compliance. • Executed QA activities related to warehouse operations and incoming material inspections, verifying adherence to cGMP requirements and internal procedures. • Reviewed and approved Change Controls, CAPAs, and Deviations, ensuring timely resolution and alignment with quality and regulatory expectations. • Led and performed investigations of non-conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution. • Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection-readiness standards. • Experienced using Veeva in the areas of Document Management, Deviation, CAPA, Training, and Change Control. • Executed daily QA operations at the manufacturing site while collaborating cross-functionally to drive compliance and continuous improvement. • Monitored and reported site quality metrics, including Deviations, CAPAs, OOS, OOT, and product disposition cycle times, to identify trends and improve performance. • Contributed to greenfield site startup and biopharmaceutical manufacturing facility operations by establishing compliant QA systems and processes. • Executed QA activities related to supplier qualification, including onboarding, monitoring, and recertification, to ensure alignment with quality standards. • Collaborated with Quality Control to verify laboratory compliance and maintain data integrity in accordance with cGMP and regulatory requirements. • Identified and escalated discrepancies or non-compliant entries within the Quality Management System (Veeva); worked with process owners to resolve issues and ensure records met regulatory and internal standards. Technical Skills • Proficient in MS Office Suite. Proficient in using Quality Management Systems for documentation, workflow management, and compliance tracking; experience with Veeva is preferred. Non-Technical Skills • Results-oriented and able to navigate ambiguity. • Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives. • Respond promptly, take accountability, and manage tasks efficiently. • Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. • Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. • Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. • Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. • Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. • Contribute positively by recognizing achievements and encouraging a healthy work-life balance. • Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. • Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. • Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role. Requires up to 10% domestic and limited international travel. The anticipated salary for this position will be $106,300 to $138,800. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Long-Term Incentive Program (subject to job level and performance) Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing ****************************************. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-SH1
    $106.3k-138.8k yearly Auto-Apply 29d ago
  • QA Specialist

    Pharmeng Technology Americas

    Quality assurance specialist job in Holly Springs, NC

    QA Specialist PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. Responsibilities Function as primary FLQA and Quality Management System (QMS) subject matter expert to assigned area(s) of responsibility within Bulk Manufacturing, QC laboratories, Fill Finish Manufacturing, Facilities, and Warehouse operations. Perform quality oversight and approval of Deviations, CAPAs, and Change Controls in collaboration with Record Owners. Ensure investigations, cause identification, CAPA development, and accurate change controls within Bulk, QC, Fill Finish, FacOps, and Warehouse departments. Track closure of assigned QMS records. Participate in suite team meetings, provide FLQA support for projects and initiatives. Conduct on-the-floor walkthroughs and coaching to instill a quality mindset, compliance knowledge, and a strong quality culture among manufacturing staff. Bring adherence to and continuous improvement of quality systems within Bulk, QC, Fill Finish, FacOps, and Warehouse departments. Support development, revision, and implementation of SOPs, protocols, and other GMP documents. Help deliver Deviation, CAPA, and Change Control Annual Product Quality Review (APQR) sub-reports. Lead continuous improvement projects, offer quality support to site capital projects and global quality system improvements. Ensure inspection readiness through routine quality walkthroughs, monitoring adherence, and direct involvement in Site Self Inspections. Be a QA SME for internal and external audits. Proficiently use computerized systems including TrackWise, Veeva QMS and QDocs, GLIMS, SAP, CMMS. Provide support to greater FLQA organization, including quality oversight of Bulk Manufacturing/QC Laboratories and QA reviews of batch records and GMP records at the site. Acquire and maintain knowledge of current local and international regulatory requirements/trends, ensuring advice and technical support on quality/compliance matters are provided to the site. Requirements Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) preferred or equivalent experience in biotech or pharmaceutical industry 3+ years' GMP experience in the pharmaceutical/biotech industry Previous experience directly working in the industry or having direct responsibilities approving GMP deviations, CAPAs, and change controls. Previous experience in root cause analysis and risk management, including working experience of root cause analysis tools such as Fishbone/5Why Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or an understanding of the quality requirements for the pharmaceutical industry. Experience with the production processes used in pharmaceutical parenteral drug product manufacturing.
    $49k-83k yearly est. Auto-Apply 60d+ ago
  • Quality Assurance Specialist

    The Steely Group

    Quality assurance specialist job in Holly Springs, NC

    This QA Specialist will provide quality support and oversight of the commissioning & qualification and process qualification with the focus on Computer System Validation and Automation support. This individual will work alongside with DTI (Digital, Technology and Innovation) and Automation to provide QA oversight of the design and technology of the DTI ecosystem and ongoing Automation support to the Manufacturing floor and expansion projects. Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance, with an emphasis on Computer Systems Validation (CSV). Work to be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight. Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution. Effectively manage relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors. Provide QA support for managing DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements. Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation. May include providing QA Oversite for Kneat protocols, Quality approval of ALM test scripts, approval of Service Now work requests, and QA approval of Maximo Work Orders. Provide quality guidance and support during execution of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required. Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes comply with applicable regulations and company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies. Participate in meetings related to document planning, execution, and issue resolution. Escalate any compliance concerns or critical gaps to QA management. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role. Requirements / Qualifications: Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience Previous experience in computer system validation (CSV) or quality oversite of CSV. Experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired. Experience with computerized systems including troubleshooting, reliability, and performance improvements.
    $49k-83k yearly est. 2d ago
  • Compliance and Quality Assurance Specialist | Quality Control and Compliance Monitoring [DOA0017016]

    Prosidian Consulting

    Quality assurance specialist job in Fayetteville, NC

    ProSidian is a Management and Operations Consulting Services Firm focusing on providing value to clients through tailored solutions based on industry-leading practices. ProSidian provides Enterprise Service Solutions for Risk Management | Compliance | Business Process | IT Effectiveness | Engineering | Environmental | Sustainability | and Human Capital. We help forward-thinking clients solve problems and improve operations. Launched by Management Consultants, our multidisciplinary teams bring together the talents of Global Professionals to complete engagements for public/private companies, defense and civilian government agencies, and non-profit organizations. Our solution-centric services are deployed across the enterprise and target drivers of economic profit (growth, margin, and efficiency). They are also aligned at the intersections of assets, processes, policies, and people delivering value. ProSidian clients represent a broad spectrum of Industry Sector Groups, including but not limited to -- Sector Groups including but not limited to Consumer Products, Services, And Retail | Defense And Military | Education And Academia | Emergency Services | Energy, Infrastructure, And Environment | Financial Services | Food And Agriculture | Foreign Aid / Technical Assistance | Government And Public Services | Healthcare And Life Sciences | Industrial And Commercial | Manufacturing And Operations | National Security & Intelligence | Non-Profit | Professional Services | Real Estate And Hospitality | Technology, Media, And Telecommunications | Transport And Logistics | etc. Learn More About ProSidian: ***************** Job Description ProSidian Seeks a Compliance and Quality Assurance Specialist | Quality Control and Compliance Monitoring [DOA0017016] for Program Support on a Exempt W2: No Overtime Pay Basis Technical Element located Fort Bragg, NC Across The Mid Atlantic Region supporting support services that supplement Soldier readiness and the well-being of the Army Family. Seeking Compliance and Quality Assurance Specialist candidates with relevant DOD/Military Sector Experience (functional and technical area expertise also ideal) to support professional services engagement for DOD/Military Sector Clients such as DOA. This as a Technical Element or Contract W-2 (IRS-1099) Quality Control and Compliance Monitoring Functional Area Professional - Regulatory Compliance Position; however, ProSidian reserves the right to convert to a Full-Time ProSidian employed W-2 Position. JOB OVERVIEW Provide services and support as a Regulatory Compliance (Compliance and Quality Assurance Specialist) in the DOD/Military Industry Sector focusing on Program / Project Management Solutions for clients such as Department of Army (DOA) | Fort Bragg Army Community Service (ACS) Family Advocacy Program (FAP) Generally Located In Fort Bragg, NC and across the Mid Atlantic Region (Of Country/World). RESPONSIBILITIES AND DUTIES - Compliance and Quality Assurance Specialist | Quality Control and Compliance Monitoring [DOA0017016] Conduct CARAT inspections and monitor corrective actions. Track SOP adherence, ICE feedback, and training metrics. Prepare quality assurance addendums for MSR. Qualifications Desired Qualifications For Compliance and Quality Assurance Specialist | Quality Control and Compliance Monitoring [DOA0017016] (DOA0017016) Candidates: QA or compliance background, preferably in military programs. Education / Experience Requirements / Qualifications Bachelor's in Quality Assurance, Social Work, or Admin. 3+ years of QA or program auditing experience. Skills Required SOP writing, checklist auditing, reporting. Competencies Required Objectivity, accountability, attention to detail. Ancillary Details Of The Roles Reviews training documentation with Educator Works with Admin and Data Analyst for MSR compliance. Other Details Central figure in class documentation validation. #TechnicalCrossCuttingJobs #Consulting #DOD/Military #GovernmentSupportServices #ProfessionalAnalyticalSupport #Jugaad #Copitas #PokaYoke Additional Information As a condition of employment, all employees are required to fulfill all requirements of the roles for which they are employed: establish, manage, pursue, and achieve annual goals and objectives with Documented Goals for each of the firm's Eight ProSidian Global Competencies [1 - Personal Effectiveness | 2 - Continuous Learning | 3 - Leadership | 4 - Client Service | 5 - Business Management | 6 - Business Development | 7 - Technical Expertise | 8 - Innovation & Knowledge Sharing (Thought Leadership)]; and to support all business development and other efforts on behalf of ProSidian Consulting. CORE COMPETENCIES Teamwork - the ability to foster teamwork collaboratively as a participant and effectively as a team leader Leadership - the ability to guide and lead colleagues on projects and initiatives Business Acumen - understanding and insight into how organizations perform, including business processes, data, systems, and people Communication - ability to effectively communicate to stakeholders of all levels orally and in writing Motivation - persistent in pursuit of quality and optimal client and company solutions Agility - ability to quickly understand and transition between different projects, concepts, initiatives, or workstreams Judgment - exercises prudence and insight in the decision-making process while being mindful of other stakeholders and long-term ramifications Organization - the ability to manage projects and actions and prioritize tasks ------------ ------------ ------------ OTHER REQUIREMENTS Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint, and Word, proficient with Adobe Acrobat, data analytic tools, and Visio, and the ability to quickly learn other tools, as necessary. Business Tools - understanding and proficiency with business tools and technology, including Microsoft Office. The ideal candidate is advanced with Excel, Access, Outlook, PowerPoint, and Word, proficient with Adobe Acrobat, data analytic tools, and Visio, and the ability to quickly learn other tools, as necessary. Commitment - to work with intelligent, interesting people with diverse backgrounds to solve the most significant challenges across private, public, and social sectors Curiosity - the ideal candidate exhibits an inquisitive nature and the ability to question the status quo among a community of people they enjoy and teams that work well together Humility - exhibits grace in success and failure while doing meaningful work where skills have an impact and make a difference Willingness - to constantly learn, share, and grow and to view the world as their classroom ------------ ------------ ------------ BENEFITS AND HIGHLIGHTS ProSidian Employee Benefits and Highlights: Your good health and well-being are essential to ProSidian Consulting. At ProSidian, we invest in our employees to help them stay healthy and achieve work-life balance. We are also pleased to offer the Employee Benefits Program, designed to promote your health and personal welfare. Our growing list of benefits currently includes the following for Full-Time Employees: Competitive Compensation: The pay range begins in the competitive ranges with Group Health Benefits, Pre-tax Employee Benefits, and Performance Incentives. The Company contributes a fixed dollar amount each month towards the Plan you elect for medical and dental benefits. Contributions are deducted on a pre-tax basis. Group Medical Health Insurance Benefits: ProSidian partners with BC/BS to offer a range of medical plans, including high-deductible health plans or PPOs. ||| Group Dental Health Insurance Benefits: ProSidian dental carriers - Delta, Aetna, Guardian, and MetLife. Group Vision Health Insurance Benefits: ProSidian offers high/low vision plans through 2 carriers: Aetna and VSP. 401(k) Retirement Savings Plan: 401(k) Retirement Savings Plans help you save for your retirement for eligible employees. A range of investment options is available with a personal financial planner to assist you. The Plan is a pre-tax Safe Harbor 401(k) Retirement Savings Plan with a company match. Vacation and Paid Time-Off (PTO) Benefits: Eligible employees use PTO for vacation, a doctor's appointment, or any number of events in their life. These benefits include Vacation/Sick days - 2 weeks/3 days | Holidays - 10 ProSidian and Government Days are given. Pre-Tax Payment Programs: Pre-Tax Payment Programs are premium-only plans (POPs) that offer eligible employees a complete Flexible Spending Account (FSA) Plan and a tax benefit. Purchasing Discounts & Savings Plans: We want you to succeed financially. Therefore, we offer a Purchasing Discounts & Savings Plan through The Corporate Perks Benefit Program. This provides special discounts for eligible employees on products and services you buy daily. Security Clearance: Due to the nature of our consulting engagements, Security Clearance is required for Engagement Teams handling sensitive Engagements in the Federal Marketplace. A Security Clearance is a valued asset in your professional portfolio and adds to your credentials. ProSidian Employee & Contractor Referral Bonus Program: ProSidian Consulting will pay up to $5k for all referrals employed for 90 days for candidates submitted through our Referral Program. Performance Incentives: Due to the nature of our consulting engagements, performance incentives are associated with each new client that each employee works to pursue and support. Flexible Spending Account: FSAs help you pay for eligible out-of-pocket health care and dependent daycare expenses on a pre-tax basis. You determine your projected costs for the Plan Year and then elect to set aside a portion of each paycheck into your FSA. Supplemental Life/Accidental Death and Dismemberment Insurance: If you want extra protection for yourself and your eligible dependents, you can elect supplemental life insurance. D&D covers death or dismemberment from an accident only. Short- and Long-Term Disability Insurance: Disability insurance plans are designed to provide income protection while you recover from a disability. ----------- ------------ ------------ ADDITIONAL INFORMATION - See Below Instructions On The Best Way To Apply ProSidian Consulting is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, Vietnam era, or another eligible veteran status, or any other protected factor. All your information will be kept confidential according to EEO guidelines. ProSidian Consulting has pledged to the Hiring Our Heroes Program of the US Chamber of Commerce Foundation and the "I Hire Military" Initiative of The North Carolina Military Business Center (NCMBC) for the State of North Carolina. All applicants are encouraged to apply regardless of Veteran Status. Furthermore, we believe in "HONOR ABOVE ALL"-success while doing things the right way. Pride comes from the challenge; the reward is excellence in the work. For Easy Application, Use Our Career Site Located On Http://*****************/ Or Send Your Resume, Bios, And Salary Expectations / Rates To *********************** & ************************* ONLY CANDIDATES WITH THE REQUIRED CRITERIA ARE CONSIDERED. Be sure to place the job reference code in the subject line of your e-mail. Be sure to include your name, address, telephone number, total compensation package, employment history, and educational credentials. Risk Management | Compliance | Business Processes | IT Effectiveness | Engineering | Environmental | Sustainability | Human Capital
    $5k monthly Easy Apply 60d+ ago
  • Associate III, Quality Assurance (On The Floor, Swing Shift)

    This Role This

    Quality assurance specialist job in Parkton, NC

    This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Associate III has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Associate III has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The QA Associate III identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Associate III performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The QA Associate III should be able to work effectively, independently and within a team framework, across multiple business areas and levels of the organization. What You'll Do Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. This includes but is not limited to Review and Approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, Validity Rules (FRRV/BOM), existing/revised MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; on the Manufacturing floor record review and observations, performing WORCs, performing inspection readiness walkthroughs, and oversight of Manufacturing operations. Supports resolution of both technical and compliance issues/gaps of low complexity CAPAs can be assigned and closed based on their understanding of the CAPA intent and review/approval of the associated document (i.e.PRCD ) at Management discretion/oversight. Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen. Provides training within and across functions, as applicable Approximately 50% of time in this position will be spent on the manufacturing floor Other duties as assigned Required Skills Bachelor's Degree required in life sciences or related Minimum of 2 years of experience working in a quality assurance position within a GMP pharma or biotech manufacturing environment Ability to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally Excellent written, verbal, and interpersonal communication skills Familiarity with downstream process manufacturing Preferred Skills Previous relevant industry experience in a GMP manufacturing environment Experience with column packing or reviewing column pack binders Job Level: Professional Additional Information The base compensation range for this role is: $69,000.00-$90,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
    $69k-90k yearly Auto-Apply 14d ago
  • Quality Assurance Senior Associate

    Actalent

    Quality assurance specialist job in Holly Springs, NC

    Job Title: Quality Assurance Senior AssociateJob Description We are seeking a dedicated and detail-oriented Quality Assurance Senior Associate to join our team. This fully onsite role requires shift work that includes weekends and possibly nights. Once established, the shift schedule will remain stable. The role is pivotal in ensuring adherence to GMP quality requirements and involves working closely with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. Responsibilities * Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations. * Ensure facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and internal requirements relating to GMP, GDP, Safety, and other controls. * Drive closure/completion, including reviewing and approving cGMP processes, procedures, documents, and records, including but not limited to deviations, investigations, and corrective actions/preventative actions (CAPAs). * Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements. * Oversee and provide guidance during on-the-floor analytical testing. * Ensure that changes potentially impacting product quality are assessed according to procedures. * Investigate and document deviations from established procedures per guidelines. * Alert Senior management of quality, compliance, supply, and safety risks. * Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. * Identify and implement continuous improvement opportunities within processes and systems. * Support and represent PQA during audits and inspections and may directly interact with regulatory agencies during on-site inspections. Essential Skills * Quality assurance expertise * Manufacturing experience * Experience with Batch Records and Deviations * QA Oversight * Experience in GNP Facilities * PQA or Manufacturing experience, preferably in Drug Substance Additional Skills & Qualifications * High school diploma/GED with 4 years of work experience, or * Associate degree with 2 years of work experience, or * Bachelor's degree with 6 months of work experience, or * Master's degree Work Environment This role involves providing on-the-floor guidance and manufacturing support, overseeing compliance in execution, reviewing Batch Records, and approving SOPs. You will engage in deviation reviews and assist in problem-solving with a quality mindset within a manufacturing setting. Job Type & Location This is a Contract position based out of Holly Springs, NC. Pay and Benefits The pay range for this position is $31.00 - $34.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Holly Springs,NC. Application Deadline This position is anticipated to close on Jan 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $31-34 hourly 5d ago
  • PT Quality Assurance Associate

    Ahold Delhaize

    Quality assurance specialist job in Laurinburg, NC

    At Food Lion, Associates are the most important assets to our organization. We want associates to have meaningful careers full of variety and challenges. Each associate contributes to the overall success of Food Lion, and in return, we strive to provide all associates with a fulfilling work experience and reward performance and commitment. We are committed to the professional development of our associates through on-the-job learning opportunities and training. JOB DESCRIPTION Count on Me - We know what to do, we make it easy, we do our part and we care! Job Title: FT/PT Quality Assurance Associate Success Factors Job Code: 1300594 Department: Center Store (Grocery) Reports To: Assistant Store Manager Where Applicable: Evening Manager Primary Purpose: Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice. Duties and Responsibilities: Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience Courteous and helpful to other associates Sweep and clean floors on nights with no scheduled vendor services Weekly cleaning of Produce, Market and Deli Departments Clean and organize the store mop room Find more efficient ways to do the job and seek to reduce costs and improve labor productivity Follow QA daily check list and sanitation standards set by Food Lion Follow current Standard Practices regarding cleanup of Hazardous Waste product Maintain a complete understanding of and adherence to company guidelines, policies and standard practice Understand and follow Food Safety and Workplace Safety guidelines and procedures Observe and correct all unsafe conditions that could cause associate or customer accidents Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty Ensure compliance with local, state and federal regulations Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses Perform all other duties as assigned Qualifications: High school graduate or equivalent preferred Excellent interpersonal, organizational, communication and customer service skills Ability and willingness to learn multiple tasks and technical requirements of the job Ability to use technical information to solve problems Must meet minimum age requirements to perform specific job functions Must be able to meet the physical requirements of the position, with or without reasonable accommodations Physical Requirements: Ability to use computers and other communication systems required to perform job functions Perform repetitive hand and arm motions Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion Pull or push up to 75 lbs. on occasion Stand 100% of the time, frequently walking short distances Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level Meet established volume activity standards for the position Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time Have sufficient visual ability to check ID cards, checks, invoices and other written documents Food Lion provides equal employment opportunities to all associates and applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth and related conditions) national origin, age, disability, sexual orientation, veteran status, gender identity or gender expression or any other characteristic protected by law. If you have a disability and require assistance in the application process, please contact our Recruiting Department at ***********************
    $46k-67k yearly est. 8d ago
  • Sr. Quality Assurance Associate - Plant Quality Assurance

    Planet Pharma 4.1company rating

    Quality assurance specialist job in Holly Springs, NC

    Pay $31-$33 per hr. Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
    $31-33 hourly 5d ago
  • Sr. Manager - QA Assurance

    Eli Lilly and Company 4.6company rating

    Quality assurance specialist job in Parkton, NC

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced Quality Assurance Manager to support our growth in Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies. Position Description: The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices. This role combines people management with technical quality expertise, driving team structuring, collaborators development, continuous improvement of regulated processes, documentation, and operational readiness. The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support. Management Responsibilities Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence. Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement. Establish and monitor performance objectives, providing feedback and coaching to drive team development. Identify business and quality risks, escalating appropriately and in a timely manner. Technical Responsibilities Provide continuous quality improvement oversight to regulated processes, practices, and documentation. Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements. Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues. Work cross-functionally with process teams for metrics reviews, operational support, and deviation management. Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance. Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings. Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines. Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes. Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions. Minimum Requirements: Bachelor's or Master's degree in Engineering, Life Sciences, or related field. 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role. Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements. Demonstrated attention to detail and ability to maintain quality systems. Previous experience leading or working effectively with a cross-functional group. Demonstrated excellent interpersonal, written and oral communication skills. Demonstrated strong technical aptitude and ability to train and mentor others. Demonstrated decision making and problem-solving skills. Demonstrated ability to organize and prioritize multiple tasks. Additional Preferences: Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc. Previous experience with Manufacturing Execution Systems and electronic batch release. CQM, CQE, or CQA certification from the American Society for Quality (ASQ). Previous experience with Trackwise, Veeva, MODA. Additional Information: The schedule for this position is 12 hours day-shift (2-2-3) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $94,500 - $138,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly
    $94.5k-138.6k yearly Auto-Apply 16d ago
  • Quality Assurance Senior Associate

    Us Tech Solutions 4.4company rating

    Quality assurance specialist job in Holly Springs, NC

    The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance **Key Responsibilities:** + Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. + Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. + Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. + Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. + Oversee and provide guidance during on-the-floor analytical testing. + Ensure that changes that could potentially impact product quality are assessed according to procedures. + Ensure that deviations from established procedures are investigated and documented per procedures. + Alert senior management of quality, compliance, supply and safety risks. + Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. + Identification and implementation of continuous improvement opportunities within our processes and systems. + Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site **Basic Qualifications:** + High school/GED + 4 years work experience or + Associate + 2 years work experience or + Bachelor + 6 months work **Must Have Skill Sets:** + Previous work on GNP Facilities + PQA or Mfg. preferably Drug Substance Experience + Previous work with Batch records/Deviations/Qa Oversight + Nice to have B.S. degree **Day to Day Responsibilities:** + On the floor guidance/Mfg. support + Oversee compliance in execution + Batch Record Review + SOP review/Approvals + Deviation Review + Help Mfg. Problem solves with Quality mindset **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** . "US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
    $47k-65k yearly est. 6d ago
  • Quality Assurance Senior Associate

    Actalent

    Quality assurance specialist job in Holly Springs, NC

    We are seeking a dedicated Quality Assurance Senior Associate to join our team. This fully onsite position follows a stable shift schedule that includes weekends and possibly nights. The role requires a background in manufacturing and PQA. As a Sr. Associate in Plant Quality Assurance, you will work directly with plant manufacturing and support groups on bulk drug substance manufacturing and new product introductions. You will facilitate real-time decision-making to ensure adherence to GMP quality requirements and foster a strong partnership between Manufacturing and Quality staff. Responsibilities * Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations. * Ensure compliance of facilities, equipment, materials, organization, processes, and procedures with applicable regulations and requirements relating to GMP, GDP, Safety, and other controls. * Drive closure and completion of cGMP processes, procedures, documents, and records, including review and approval of deviations, investigations, and corrective/preventative actions (CAPAs). * Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements. * Oversee and provide guidance during on-the-floor analytical testing. * Assess changes that could potentially impact product quality according to procedures. * Investigate and document deviations from established procedures per guidelines. * Alert management of quality compliance, supply, and safety risks. * Provide project management support, leading efforts to achieve timely task completion and develop strategies for system implementation. * Identify and implement continuous improvement opportunities within processes and systems. * Support and represent PQA during audits and inspections, and directly interact with regulatory agencies during on-site inspections. Essential Skills * Quality assurance * Manufacturing * Batch Records * Deviations * QA Oversight * Experience in GNP Facilities * PQA or Manufacturing experience, preferably in Drug Substance Additional Skills & Qualifications * High school diploma/GED with 4 years of work experience or Associate degree with 2 years of work experience or Bachelor's degree with 6 months of work experience or Master's degree Work Environment This is an on-the-floor position providing guidance and support to manufacturing. You will oversee compliance in execution, review batch records, review and approve SOPs, and review deviations. You will also assist manufacturing in problem-solving with a quality mindset. Job Type & Location This is a Contract position based out of Holly Springs, NC. Pay and Benefits The pay range for this position is $31.00 - $34.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Holly Springs,NC. Application Deadline This position is anticipated to close on Jan 29, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $31-34 hourly 5d ago
  • Quality Assurance Senior Associate

    The Steely Group

    Quality assurance specialist job in Holly Springs, NC

    The Sr. Associate, Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The Sr Associate, PQA position will facilitate real-time decision-making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. Responsibilities: Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support. Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems. Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Requirements / Qualifications: High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required. Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment. Strong GMP and GDP Behaviors. Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations. Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.
    $46k-67k yearly est. 5d ago
  • Quality Assurance Senior Associate

    Actalent

    Quality assurance specialist job in Holly Springs, NC

    We are seeking a dedicated Quality Assurance Senior Associate to join our team. This fully onsite position follows a stable shift schedule that includes weekends and possibly nights. The role requires a background in manufacturing and PQA. As a Sr. Associate in Plant Quality Assurance, you will work directly with plant manufacturing and support groups on bulk drug substance manufacturing and new product introductions. You will facilitate real-time decision-making to ensure adherence to GMP quality requirements and foster a strong partnership between Manufacturing and Quality staff. Responsibilities + Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations. + Ensure compliance of facilities, equipment, materials, organization, processes, and procedures with applicable regulations and requirements relating to GMP, GDP, Safety, and other controls. + Drive closure and completion of cGMP processes, procedures, documents, and records, including review and approval of deviations, investigations, and corrective/preventative actions (CAPAs). + Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements. + Oversee and provide guidance during on-the-floor analytical testing. + Assess changes that could potentially impact product quality according to procedures. + Investigate and document deviations from established procedures per guidelines. + Alert management of quality compliance, supply, and safety risks. + Provide project management support, leading efforts to achieve timely task completion and develop strategies for system implementation. + Identify and implement continuous improvement opportunities within processes and systems. + Support and represent PQA during audits and inspections, and directly interact with regulatory agencies during on-site inspections. Essential Skills + Quality assurance + Manufacturing + Batch Records + Deviations + QA Oversight + Experience in GNP Facilities + PQA or Manufacturing experience, preferably in Drug Substance Additional Skills & Qualifications + High school diploma/GED with 4 years of work experience or Associate degree with 2 years of work experience or Bachelor's degree with 6 months of work experience or Master's degree Work Environment This is an on-the-floor position providing guidance and support to manufacturing. You will oversee compliance in execution, review batch records, review and approve SOPs, and review deviations. You will also assist manufacturing in problem-solving with a quality mindset. Job Type & Location This is a Contract position based out of Holly Springs, NC. Pay and Benefits The pay range for this position is $31.00 - $34.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Holly Springs,NC. Application Deadline This position is anticipated to close on Jan 29, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $31-34 hourly 5d ago

Learn more about quality assurance specialist jobs

How much does a quality assurance specialist earn in Fayetteville, NC?

The average quality assurance specialist in Fayetteville, NC earns between $37,000 and $103,000 annually. This compares to the national average quality assurance specialist range of $41,000 to $97,000.

Average quality assurance specialist salary in Fayetteville, NC

$62,000

What are the biggest employers of Quality Assurance Specialists in Fayetteville, NC?

The biggest employers of Quality Assurance Specialists in Fayetteville, NC are:
  1. Prosidian Consulting
Job type you want
Full Time
Part Time
Internship
Temporary