Sr Associate QA - PQA - 1st Shift
About The Position
The Sr Associate Quality Assurance – PQA works directly with plant manufacturing and support groups to support ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. The role facilitates real-time decisions that ensure adherence to GMP quality requirements and helps build a strong partnership and learning environment between Manufacturing and Quality by providing coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance. The position provides quality oversight for facility commissioning and qualification, analytical equipment qualification and validation, new product introduction, and ongoing manufacturing and testing activities. The successful candidate supports project and system implementation, continuous improvement, audits, and inspections. This is an on-site role. PQA staff work different shift structures to support 24/7 operations; the successful incumbent is expected to transition to a shift schedule that includes late afternoons and nights.
Requirements
- High school diploma/GED and 4 years of quality, manufacturing, and/or other regulated-environment work experience; or an associate degree and 2 years of such experience; or a bachelor's degree and 6 months of such experience; or a master's degree.
- Strong cGMP and GDP behaviors.
- Knowledge of and process experience within a cGMP manufacturing facility or another highly regulated environment.
- Proficiency in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and electronic quality systems.
- Strong organizational skills and ability to manage multiple tasks, follow assignments through to completion, and meet timelines.
- Strong written and oral communication skills.
- Ability to work both as a team player and independently.
Nice To Haves
- Experience in biotechnology or pharmaceutical plant start-up.
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
- Demonstrated experience with deviation records.
- Experience supporting GMP testing laboratories.
Responsibilities
- Support facility commissioning and qualification and analytical equipment qualification and validation activities, including quality review and approval of documents according to project timelines.
- Provide quality oversight of new product introduction activities involving facilities, utilities, equipment, systems, and processes, aligning them with Amgen Quality Systems.
- Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed according to cGMP, GDP, and applicable regulations.
- Ensure facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements for GMP, GDP, safety, and other controls.
- Drive completion and closure of cGMP processes, procedures, documents, and records, including deviations, investigations, CAPAs, change controls, and validations; review and approve as appropriate.
- Ensure production and testing records and results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.
- Oversee and provide guidance during on-the-floor analytical testing.
- Ensure changes that could affect product quality are assessed according to procedures.
- Ensure deviations from established procedures are investigated and documented according to procedures.
- Alert senior management to quality, compliance, supply, and safety risks.
- Provide project management support, lead efforts to achieve tasks on time, and develop strategies for system implementation.
- Identify and implement continuous improvement opportunities in processes and systems.
- Support and represent PQA during audits and inspections and potentially interact directly with regulatory agencies during on-site inspections.
Benefits
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
