QA Specialist, QC Compliance

The QA Specialist, QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist, QC Compliance helps drive Quality oversight for the direction of all QC laboratory processes, from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other project teams and QA departments at other sites to align strategies and procedures. This role ensures QC laboratory systems and processes are operated and maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, as well as QA oversight of day-to-day activities and resolution or mitigation of issues. This role participates in optimization and improvement initiatives and supports regulatory agency and third-party inspections.What You’ll DoProvides QA oversight and support for project deliverables in accordance with the governing processes and procedures for the QC laboratory program.Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure laboratory systems are first validated, and then maintained in a validated state through site startup and into commercial operation.Provides oversight and approval of 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.Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for laboratory equipment and systems.Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facilities.Ensures that project and operational quality objectives are met within desired timelines.Actively seeks opportunities to collaborate and align with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.Performs other duties, as assigned.Knowledge, Skills, and Abilities Excellent oral and written communications skills and fluency in English.Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.Understanding of GAMP5, USP <1058>, Data Integrity, and application of EU Annex 1, 21 CFR Parts 11 and 820 as pertains to lab processes.Understanding of validation of laboratory benchtop and support equipment, and methodologies.Knowledge and application of cGMP compliance and other related regulations.Strong communication skills to partner with different teams and stakeholders.Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.Ability to think critically and have superior problem-solving skills.Team-based attitude and ability to build relationships and communicate effectively with others.Must be flexible to support 24/7 manufacturing facility.Minimum QualificationsBachelor’s degree in Life Sciences or Engineering with 2+ years of experience; OR,Master’s degree in Life Sciences or Engineering with 0 years of experience.1-3 years of experience in a GMP environment.1+ 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 QualificationsPrior 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 & 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.