Quality Assurance Senior Associate

Job Title: Quality Assurance Senior AssociateJob DescriptionWe 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.ResponsibilitiesProvide 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 SkillsQuality assurance expertiseManufacturing experienceExperience with Batch Records and DeviationsQA OversightExperience in GNP FacilitiesPQA or Manufacturing experience, preferably in Drug SubstanceAdditional Skills & QualificationsHigh school diploma/GED with 4 years of work experience, orAssociate degree with 2 years of work experience, orBachelor's degree with 6 months of work experience, orMaster's degreeWork EnvironmentThis 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 & LocationThis is a Contract position based out of Holly Springs, NC.Pay and BenefitsThe 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 TypeThis is a fully onsite position in Holly Springs,NC.Application DeadlineThis position is anticipated to close on Jan 28, 2026.About ActalentActalent 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.