Quality Control Specialist
About The Position
We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities. The QC Data Services Specialist is responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs. They demonstrate mastery of all data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other company divisions and third-party manufacturing and packaging sites. Assures compliance with FDA & GMP regulations. Demonstrates the ability to influence a team (including Global Support and Outside Organizations) and is a recognized resource to others.
Requirements
- Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting
- Prior experience in a pharmaceutical laboratory setting
- Knowledge and experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)
- Adaptability
- Analytical Instrumentation
- Analytical Method Development
- Dissolution Testing
- Driving Continuous Improvement
- GMP Compliance
- Karl Fischer Titrations
- Laboratory Documentation
- Laboratory Safety
- Microbiological Analysis
- Microbiological Test
- Teamwork
- Technical Writing
- Troubleshooting
- Use of Laboratory Equipment
Responsibilities
- Stability laboratory data review
- Plant site release
- Review of site APR
- Data trending
- Support of Quality Notifications and CAPAs
- Demonstrates mastery of all data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)
- Maintains positive site relations and supports other company divisions and third-party manufacturing and packaging sites
- Assures compliance with FDA & GMP regulations
- Demonstrates the ability to influence a team (including Global Support and Outside Organizations) and is a recognized resource to others
- Participate in development of objectives and ensure alignment with site goals
- Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence, reduce laboratory downtime and increase reliability
- Following standard work for escalation as it relates to safety and quality events
- Timely approval of qualification, change control, procedures and other documents
- Demonstrates a deep understanding of customer needs, requirements, and expectations
- Performs stability and plant site release and study approvals
- Supports GLIMS updates; reviews builds, IPI specification verification
- Review of technical memos and testing protocols
- Attends departmental and team meetings focused on Stability data review and reporting
- Serves as liaison between NASU teams, Leadership, and External Entities
- Ability to interpret our Company Quality Policies and Guidelines for daily application
- Participates and/or Directs Tier Meetings
- Promotes teamwork and open discussion of issues
- Statistical summary analysis for manufacturing site Annual Product Reviews (APR)
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
