Sr Associate Quality Assurance - Holly Springs, NC

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS – This posting is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. The role is an on‑site position unless otherwise stated. SR ASSOCIATE QUALITY ASSURANCE – PQA Senior Associate Plant Quality Assurance (PQA) works directly with plant manufacturing and support groups for ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The role facilitates real‑time decision making to ensure adherence to GMP quality requirements and supports quality systems and compliance. Responsibilities Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and processes with alignment into the Amgen Quality Systems. Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes and procedures comply with applicable regulations and Amgen requirements related to GMP, GDP, safety and other controls. Drive closure and completion of cGMP processes, procedures, documents and records, including deviations, investigations, 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‑floor analytical testing. Assess changes that could potentially impact product quality according to procedures. Investigate and document deviations from established 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. Identify and implement continuous improvement opportunities within processes and systems. Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Minimum Education Required High School/GED. Basic Qualifications High school/GED + 4 years of Quality Assurance, manufacturing and/or other regulated environment work experience. Associate’s degree + 2 years of Quality Assurance, manufacturing and/or other regulated environment work experience. Bachelor’s degree + 6 months of Quality Assurance, manufacturing and/or other regulated environment work experience. Master’s degree. Preferred Qualifications Strong cGMP and GDP behaviors. Experience in biotechnology or pharmaceutical plant start‑up. Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment. Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation. Proficient Microsoft Office skills and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems. Demonstrated experience with deviation records. Experience supporting GMP testing laboratories. Strong organizational skills and ability to manage multiple tasks simultaneously and meet timelines. Strong communication skills, both written and oral. Demonstrated ability to work as a team player and independently. Benefits Comprehensive employee benefits package including health, dental, vision, life and disability insurance, and flexible spending accounts. Retirement and savings plan with generous company contributions. Discretionary annual bonus program (or sales‑based incentive plan for field sales representatives). Stock‑based long‑term incentives. Award‑winning time‑off plans. Flexible work models where possible. Salary Range $75,000 – $111,052. #J-18808-Ljbffr VetJobs