Sr Associate QA - PQA - 1st Shift

Amgen • Holly Springs, NC

1d • Onsite

About The Position

The Senior Associate 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 a strong partnership between Manufacturing and Quality through coaching, guidance, and direction on manufacturing events, deviations, quality systems, and compliance.

This on-site position supports ANC facility commissioning and qualification, manufacturing analytical equipment qualification and validation, and new product introduction activities involving facilities, utilities, equipment, systems, and processes. The role provides ongoing quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with cGMP, GDP, applicable regulations, and Amgen requirements. The successful candidate is expected to transition to a shift-working schedule that includes late afternoons and nights; the PQA team supports 24/7 operations through different shift structures.

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.
• Experience in biotechnology or pharmaceutical plant start-up.
• Knowledge of and process experience within a cGMP manufacturing facility or another highly regulated environment.
• Technical understanding of upstream and/or downstream manufacturing in a biotechnology production operation.
• Proficient Microsoft Office skills and knowledge of 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, follow assignments through to completion, and meet timelines.
• Strong written and oral communication skills.
• Ability to work as a team player and independently.
• Ability to work on-site and transition to a shift schedule that includes late afternoons and nights.

Responsibilities

• Support facility commissioning and qualification, analytical equipment qualification and validation, and 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, including related commissioning, qualification, validation, and document support.
• Ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices, Good Documentation Practices, 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 control records, 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 achieve tasks on time, and develop strategies for system implementation.
• Identify and implement continuous improvement opportunities within processes and systems.
• Support and represent PQA during audits and inspections and potentially interact directly with regulatory agencies during on-site inspections.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED