Specialist QA 1

Specialist QA 1 – Plant Quality Assurance (PQA)

Amgen is hiring a Quality Assurance Specialist for Plant Quality Assurance (PQA) in Holly Springs, North Carolina. In this role you will work directly with Manufacturing staff during bulk drug substance operations and help them make real-time decisions about quality requirements and deviations. You will also coach and guide Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff on compliance and quality systems.

What you will do

• Provide Quality oversight so that products are manufactured, tested, stored and distributed according to cGMP, GDP and other applicable regulations.
• Make sure facilities, equipment, materials, organization, processes and procedures comply with applicable regulations and Amgen requirements.
• Review and approve cGMP processes, procedures, documents and records, including Batch Production Records, Deviations, work orders, Change Controls and CAPA.
• Author, review and approve quality documents such as SOPs, user requirements, risk assessments, training materials, engineering and automation documents, environmental qualification protocols/reports and validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Make sure production records and test results are complete, accurate and documented according to written procedures and cGMP requirements.
• Make sure changes that could affect product quality are assessed according to procedures.
• Make sure deviations are investigated and documented according to procedures.
• Alert senior management to quality, compliance, supply and safety risks.
• Provide project management support and develop strategies for system implementation.
• Identify and implement continuous improvement opportunities.
• Support and represent PQA during audits and inspections; you may interact directly with regulatory agencies during on-site inspections.

Basic Qualifications

• High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience, OR
• Associate's degree and 8 years of such experience, OR
• Bachelor's degree and 4 years of such experience, OR
• Master's degree and 2 years of such experience, OR
• Doctorate degree

Preferred Qualifications

• Educational background in Life Science or Engineering.
• Understanding of the regulations, standards and guidelines for cGMP biotech manufacturing in a multi-product environment, including familiarity with cell banking, cell culture and protein purification.
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
• Familiarity with computer/automation systems (MES, Delta-V, PI data historian).
• Ability to build strong partnerships with client groups and influence practices to keep operations compliant.
• Problem-solving skills and experience managing Root Cause Analysis / Deviation investigations.
• Experience participating in, managing and responding to health authority inspections and partner/corporate audits.
• Strong organizational skills and excellent written and verbal communication skills.

What you can expect of us

Salary range: $104,287.35 – $141,094.65 USD. Amgen's Total Rewards Plan includes a Retirement and Savings Plan with generous company contributions; group medical, dental and vision coverage; life and disability insurance; flexible spending accounts; a discretionary annual bonus; stock-based long-term incentives; award-winning time-off plans; and flexible work models where possible.

Amgen does not have an application deadline for this position. Sponsorship is not guaranteed. Amgen is an Equal Opportunity employer.