Sr Associate Quality Assurance - PQA - Night Shift
About The Position
The Sr. Associate Plant Quality Assurance (PQA) is an on-the-floor role working directly with plant manufacturing and support groups on 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 builds a strong partnership and learning environment between Manufacturing and Quality through coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance. PQA staff are on-site workers supporting 24/7 operations through different shift structures. After the facility startup phase, the successful incumbent is expected to transition to a shift schedule that includes late afternoons and nights.
Requirements
- High school diploma or GED and 4 years of Quality Assurance, 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 in a cGMP manufacturing facility or another highly regulated environment.
- Proficient Microsoft Office skills.
- Strong organizational skills and the 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 member and independently.
Nice To Haves
- Experience in biotechnology or pharmaceutical plant startup.
- Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.
- Knowledge of electronic systems such as EBR/MES, Delta V, and electronic quality systems.
- Demonstrated experience with deviation records.
- Experience supporting GMP testing laboratories.
Responsibilities
- Provide quality oversight for new product introduction activities involving facilities, utilities, equipment, systems, and processes, including support for commissioning, qualification, validation, and new document activities.
- Provide ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (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 closure and completion, including review and approval, of cGMP processes, procedures, documents, and records, including deviations, investigations, CAPAs, change controls, and validations.
- 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 potentially 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 complete 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 generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Flexible spending accounts
- Discretionary annual bonus program or, for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Career development opportunities
- Work/life balance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
