Manager, Document Control
Location
United States
Posted
3 days ago
Salary
0
Seniority
Senior
Job Description
Manager, Document Control
Quva
• Accountable & responsible for creation and revisions of SOPs, WIs, Policies, and other Quva documents in compliance with cGMP regulations • Accountable & Responsible for Document Change Requests (DCR) • Accountable & Responsible for DCR Creator/Revisor Instructor Lead Training (ILT) • Supports training activities for batch record/logbook issuance & archiving • Accountable for batch record and logbook issuance and archiving • Assures compliance with cGMP regulations, Quva Pharma standards, and applicable regulatory requirements • Drives improvement of processes of the quality system • Performs assigned tasks and work to achieve company goals and department objectives • Tracks and/or manages Corrective and Preventative Action (CAPA) actions as they apply to Data Integrity Compliance • Assists in customer and/or regulatory audits • Verification of templates and SKU data • Check eBR and assign template in Infor for new SKUs • Verify Quva field data for entries created for eBR and maintain as necessary • Assist MC with template creation as necessary • Infor integration-provide information as necessary • Update SOP and MC role matrix for eBR responsibilities
Job Requirements
- Bachelor’s Degree in Science or related field required (Chemistry, Microbiology or Biology preferred)
- 5+ years of relevant work experience in pharmaceuticals, preferably biotechnology within a Quality role
- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP)
- Knowledgeable in Quality Management Systems
- Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints
- Ability to audit GxP processes and Quality Management Systems
- Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit report
- 18+ years of age
- Able to successfully complete a drug and background check
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas.
Benefits
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 22 paid days off plus 8 paid holidays per year
- Occasional weekend and overtime opportunities with advance notice
- National, industry-leading high growth company with future career advancement opportunities
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