QA Specialist, DSM (Project QA)

FUJIFILM Diosynth Biotechnologies • Holly Springs, NC

114d

About The Position

The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project 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, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

Requirements

• 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.

Nice To Haves

• 2+ years of experience in GMP Quality Assurance and/or similar role.
• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.

Responsibilities

• Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
• 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 Diosynth Biotechnologies sites.
• Perform other duties, as assigned.

What This Job Offers

• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree