QA Specialist, QC Compliance
About The Position
The QA Specialist, QC Compliance partners in Quality oversight of the Quality Control area, supporting QC laboratory processes from project phase through operational readiness and overseeing validation program execution. The role collaborates with project teams and QA departments at other sites to align strategies and procedures. It ensures QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, including consistent policy administration, day-to-day QA oversight, and resolution or mitigation of issues. The specialist also contributes to optimization and improvement initiatives and supports regulatory agency and third-party inspections.
Requirements
- Bachelor’s degree in Life Sciences or Engineering and 2 or more years of experience, or a Master’s degree in Life Sciences or Engineering and 0 years of experience.
- 1–3 years of experience in a GMP environment.
- At least 1 year of experience in GMP Quality Assurance and/or a similar role.
- Experience in validation, cGMP manufacturing operations, and/or Quality oversight in an FDA-regulated facility.
- Excellent oral and written communication skills and fluency in English.
- Collaborative attitude and willingness to work with global peers and cross-functional teams.
- Understanding of GAMP5, USP <1058>, data integrity, and application of EU Annex 1, 21 CFR Parts 11 and 820 as they pertain to laboratory processes.
- Understanding of validation of laboratory benchtop and support equipment and methodologies.
- Knowledge and application of cGMP compliance and related regulations.
- Strong communication, time-management, prioritization, critical-thinking, and problem-solving skills.
- Ability to build relationships and communicate effectively with others.
- Flexibility to support a 24/7 manufacturing facility.
Nice To Haves
- Prior experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl, and/or Kneat validation software.
- Basic experience or understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing and IT systems, and methodologies.
- Prior experience and basic understanding of cell culture, upstream processes, large-scale recovery, and/or downstream processes.
- Prior experience or understanding of GAMP5, data integrity, and application of 21 CFR Part 280 and Part 11.
- Training and/or familiarity with Quality Risk Management principles.
Responsibilities
- Provide QA oversight and support for QC laboratory program project deliverables in accordance with governing processes and procedures.
- Assess the impact of system and process modifications and oversee change management to ensure laboratory systems are validated and remain in a validated state through site startup and commercial operation.
- Oversee and approve laboratory system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
- Generate, review, and approve QA procedures for validation approaches and lifecycle documentation for laboratory equipment and systems.
- Generate, review, and approve QA documentation, procedures, and processes for operational readiness and QA support of laboratory operations in cGMP-regulated facilities.
- Ensure project and operational quality objectives are met within desired timelines.
- Collaborate with other FUJIFILM Biotechnologies sites to align and streamline processes and maximize efficiency.
- Support regulatory agency and third-party inspections.
- Participate in optimization and improvement initiatives.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
