FUJIFILM Diosynth Biotechnologies · 16 hours ago
QC Supervisor, Cell Biology - Second Shift (On-site in College Station, TX)
United States
Full-time
Remote
Senior Level
5+ years exp
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Hiring Manager
Lisa Cramer, MBA
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Responsibilities
Supervise and lead the QC Cell Biology/Immunology Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
Coordinate QC testing for GMP release and stability testing.
Ensure QC equipment is maintained in a qualified state.
Prepares and executes tech transfer, qualification and validation protocols and reports as needed.
Writes, revises, and reviews Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
Establish a system for managing test samples, reagents and reference standards.
Critical reagent / system suitability qualification and management.
Review and approve data / reports during release & stability testing.
Ensures laboratory compliance to established specifications and procedures.
Reports excursion/out of specifications results and conducts investigations as needed.
Assure the implementation of appropriate and timely corrective actions.
Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team.
Follow all established laboratory, regulatory, safety, and environmental procedures.
Identify deviations and report possible preventative and corrective actions.
Perform other duties as assigned.
Qualification
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Required
Master’s degree preferably in Biology, Biochemistry, or a related scientific discipline with 3+ years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
Bachelor’s degree preferably in Biology, Biochemistry, or a related scientific discipline with 5+ years’ industry experience in a GMP / GxP or a comparable federally regulated environment.
2+ years of experience in a supervisory or lead role required.
Sound understanding and knowledge of ELISA based methods including potency and colorimetric assays.
Operate as a team leader, coordinate staff scheduling.
Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
Develop staff to maximize contributions to team and company.
Ability to multi-task and prioritize work assignments with little supervision.
Excellent attention to detail.
Computer proficiency required.
Ability to accurately review and complete required documentation.
Excellent written and oral communication skills.
Excellent organization and analytical skills.
Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Company
FUJIFILM Diosynth Biotechnologies
Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.
1,001-5,000 employees
H1B Sponsorship
FUJIFILM Diosynth Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Morten Munk
Director - Global Alliance Management
S
Sharyn Farnsworth
Associate Principal Scientist
Recent News
GlobeNewswire News Room
2024-11-21
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2024-05-24
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