Quality Assurance Specialist

Role Summary

Quality Assurance Specialist responsible for Plant Quality Assurance (PQA) during bulk drug substance operations, enabling real-time decision-making regarding quality requirements and deviations. Builds strong partnerships between Manufacturing and Quality staff and provides coaching, guidance, and direction to Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering on compliance and quality systems.

Responsibilities

• Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA).
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Qualifications

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

• Preferred: Educational background in Life Science or Engineering.
• Preferred: Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Preferred: Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
• Preferred: Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian).
• Preferred: Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
• Preferred: Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Preferred: Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
• Preferred: Strong organizational skills, including ability to follow assignments through to completion.
• Preferred: Excellent written and verbal communication skills.

Education