Position Overview:
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.
Job Description:

MINIMUM 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

PREFERRED REQUIREMENTS:

• 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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS:

• Ability to discern audible cues
• Ability to stand for prolonged periods of time, up to 30 minutes
• Ability to sit for prolonged periods of time, up to 120 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
  To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures

• Provides QA support of DSM tasks such as
  o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
  o Real time event triage and implementation of immediate response to identified deviations
  o Area changeover and return to service

  o 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
• Works 12-hour shift on 2-2-3 cadence, 0600-1800
• Perform other duties, as assigned