FUJIFILM Diosynth Biotechnologies · 1 day ago
Senior QA Analyst - Night Shift (On-site in College Station, TX)
United States
Full-time
Remote
Senior Level
3+ years exp
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Hiring Manager
Lisa Cramer, MBA
Insider Connection @FUJIFILM Diosynth Biotechnologies
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Responsibilities
Review and/or approve basic and technical documentation with minimal supervisory oversight to include, but not limited to:
-Standard Operating Procedures
-Batch Production Records (completed and approval)
-Commissioning, qualification and validation protocols and reports
-Deviation Reports
-Corrective Action/Preventive Action Plans
-Technical data review and approval
-QC data review and approval
-Drug Substance/Product Reports
-Trending QA data
Draft and review internal Quality policies, procedures and reports.
Perform inspection of final product containers and review and/or approval of executed process records and data.
Perform Quality audit functions to include, but not limited to:
-Audit of lab notebooks
-Audit of equipment logbooks
-Review of vendor, supplier, contract laboratory audit questionnaires
-Lead vendor, supplier, contract laboratory and client audits
Identify process and Quality System improvement opportunities.
Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
Support Regulatory, client, and internal audits.
Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Assist with technical oversight/training for the QA team.
Assist with compliance related functions.
Ensure priority task coverage.
Escalate any issues as identified to Quality Management and/or departmental Management as needed.
All other duties as assigned.
Qualification
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Required
Master’s Degree and 3+ years of Pharmaceutical or other regulated Industry experience.
Bachelor’s Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
Associate’s degree and 7+ years of Pharmaceutical or other regulated Industry experience.
Excellent written and oral communication skills.
Excellent organizational, analytical, data review and report writing skills.
Ability to set personal performance goals and provide input to departmental objectives.
Ability to multitask and easily prioritize your work.
Ability to work independently with little supervision.
Proficient in Microsoft Excel, Word and PowerPoint.
All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
Role model for company core values of trust, delighting our customers, Gemba, and Genki.
Preferred
Certified Quality Auditor preferred.
Degree in Biology or Chemistry preferred.
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
Wake County Government (.gov)
2024-05-24
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