Sr Associate Quality Assurance - PQA - 2nd Shift

Amgen•Holly Springs, NC

2d•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. The role works directly with plant manufacturing and support groups and facilitates real-time decisions to ensure adherence to GMP quality requirements. It also 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 supports ANC facility commissioning and qualification, manufacturing analytical equipment qualification and validation, and new product introduction quality oversight for facilities, utilities, equipment, systems, and processes. It ensures manufacturing, testing, storage, and distribution comply with cGMP, GDP, applicable regulations, and Amgen requirements. The role also supports project management, audits, inspections, and continuous improvement. This is an on-site role on the Plant Quality Assurance team. Staff work different shift structures to support 24/7 operations. The position is intended for second-shift hours, from early afternoon through late evening; specific hours depend on operational needs. The incumbent is expected to transition to a shift schedule that includes weekends.

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 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 the ability to manage multiple tasks, follow assignments through to completion, and meet timelines.
Strong written and oral communication skills.
Demonstrated ability to work 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 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 document support as needed.
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 and closure, 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 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, potentially interacting directly with regulatory agencies during on-site inspections.
Work a shift schedule that includes weekends, with second-shift hours intended to run from early afternoon through late evening.

Benefits

Comprehensive employee benefits package.
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.
Flexible work models where possible.
Career development opportunities.