The Senior QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working directly with Manufacturing staff during drug substance operations to support real-time decisions on quality requirements and deviations. This role fosters strong partnership and knowledge sharing between Manufacturing and Quality teams while providing coaching, guidance, and direction to Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering staff on compliance, quality systems, day-to-day QA oversight, and issue resolution or mitigation. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.
What You'll Do:
Responsible for providing Quality oversight to ensure that Drug Substance is 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 Fujifilm 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 manufacturing QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. Performs other duties, as assigned.
Knowledge, Skills, and Abilities:
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.
Collaborative attitude with the willingness to work with global peers and cross-functional teams to build strong partnerships, influence compliant operations, and achieve company and department goals.
Excellent oral and written communications skills and fluency in English.
Attention to detail with strong organizational skills and a commitment to maintaining quality standards while following assignments through to completion.
Problem solving & conflict resolution.
Provide source of knowledge and possess ability to mentor job duties for less experienced team members.
Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
Familiarity with Computer / Automation systems (MES, Delta-V, SAP, PI data historian).Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
Experience participating in, managing, and responding to health authority inspections, partner, and corporate audits.
Minimum Qualifications:
Bachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience; OR, Master's degree in Life Sciences or Engineering and 6+ years of applicable experience; OR, PhD in Life Sciences or Engineering and 3+ years of applicable experience.5+ years of experience in GMP Quality Assurance and/or similar role. Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
Preferred Qualifications:
Prior Experience and Working knowledge of Trackwise, Veeva, and/or Kneat validation software.
Knowledge of electronic batch records and review-by-exception practices.
Prior experience and knowledge with Quality Risk Management principles.
Advanced Understanding of drug substance manufacturing including cell culture, upstream processes, large scale recovery and/or downstream processes.
Expertise in cGMP & FDA regulations.
Experience with startup projects or initiatives.
Occasional opportunity for International and/or Domestic travel may be available.
