Sr Associate Quality Assurance - PQA - 2nd Shift

Amgen•Holly Springs, NC

3d•$82,082 - $111,052•Onsite

About The Position

The Sr Associate Quality Assurance I – PQA supports ongoing bulk drug substance manufacturing and new product introduction, including development, clinical, and commercial operations. Working directly with plant manufacturing and support groups, the role facilitates real-time decisions that ensure compliance with GMP quality requirements and strengthens partnership between Manufacturing and Quality through coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance. The role is part of an on-site Plant Quality Assurance team supporting 24/7 operations. The successful candidate is expected to transition to a shift schedule that includes weekends and is intended to cover second-shift hours, from early afternoon through late evening. Specific hours depend on operational needs. The position supports facility commissioning and qualification, analytical equipment qualification and validation, and quality oversight of new product introduction. It ensures products, facilities, equipment, materials, processes, records, and procedures meet current Good Manufacturing Practices, Good Documentation Practices, applicable regulations, and Amgen requirements. The role also supports audits and inspections, continuous improvement, and project efforts to implement systems and complete tasks on time.

Requirements

High school diploma or GED and 4 years of work experience in Quality, manufacturing, and/or another regulated environment; 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.
Proficient Microsoft Office skills.
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 effectively both as a team member and independently.
Availability for the on-site shift schedule, including weekends, with intended second-shift hours; specific hours depend on operational needs.

Nice To Haves

Experience in biotechnology or pharmaceutical plant start-up.
Technical understanding of upstream and/or downstream manufacturing in 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

Support facility commissioning and qualification, as well as manufacturing analytical equipment qualification and validation; review and approve documents according to project timelines.
Provide quality oversight of new product introduction activities involving facilities, utilities, equipment, systems, and processes, including commissioning, qualification, validation, and new document support.
Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with 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 of cGMP processes, procedures, documents, and records, including review and approval of 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 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

Health and welfare plans for staff and eligible dependents.
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.
Flexible work models where possible.