Specialist, QA Operations

The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

What You’ll Do

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as:
• Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool.
• Real time event triage and implementation of immediate response to identified deviations.
• Area changeover and return to service.
• Real time WO oversight per applicable procedures.
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites.
• Perform other duties, as assigned.

Knowledge, Skills, and Abilities

• Strong verbal and written communication skills to partner with different teams and stakeholders.
• Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
• Basic knowledge and application of cGMP compliance and other related regulations.
• Excellent oral and written communications skills and fluency in English.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 required.
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
• Team based attitude and ability to build relationships, and communicate effectively with others.
• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
• Collaborative attitude with the willingness to work with global peers and cross‐functional teams toward company and department goals.
• Occasional opportunity for International and/or Domestic travel may be available.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience; OR,
• Masters in Life Sciences or Engineering or equivalent with 0 years’ relevant experience.
• 1-3 years’ experience in a GMP environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.