Sr. Quality Specialist
Quality Specialist/Sr. Quality Specialist
This position is responsible for Quality Assurance (QA) activities related to the analytical and Quality Control (QC) labs.
What The Job Entails
Travel: Occasionally will travel to client sites for audits.
Analytical/QC lab activities - Equipment
- Review and approve existing and new equipment PM, calibration & IQ/OQ/PQ documentation including validation protocols/reports, design review/qualification (URS, FRS, DRS, SAT/FAT), impact and risk assessments.
- Review and approve software implementation, validation, maintenance and support documentation.
- Facilitate ongoing lifecycle management for laboratory commissioning, qualification, and validation programs.
- Review and approve quality events/investigations related to protocol discrepancies, unexpected results and equipment/instrument failures evaluating impacts to equipment status and product.
- Review and approve change controls related to new and existing equipment activities.
Analytical/QC lab activities – Data/Documentation
- Data review including notebook writeups, CDS raw data, audit trails, adherence to methods and protocols.
- Tracking, compiling and evaluating analytical data.
- Review and approve documentation such as methods, protocols, reports, SOPs, forms, lists etc.
- Generate and review COAs based on analytical data.
- Review and approve quality events/investigations/OOS related to protocols, methods, transfers and analytical results and evaluating impacts to documentation, products and processes.
- Review and approve change controls.
Analytical/QC lab activities - Programs
- Stability program oversight with data analytics/statistical analysis of each protocol.
- Reference standard program tracking, evaluation and qualification.
Tech Transfer activities
- Interactions with customers/suppliers regarding technical analytical inquiries.
- Coordinating method transfers to/from customers and contract labs by writing, reviewing and approving method transfer master plans, protocols and reports.
- Writing and reviewing technical packages related to analytical data, transfers and laboratory equipment.
- Coordinate testing with external laboratories and review incoming data.
Our ideal candidate
- Bachelor of Science / Master of Science in chemistry or related field with 6+ years of QA experience.
- GMP related experience in pharmaceutical or related industry with direct quality validation experience for lab equipment.
- Practical application of analytical and organic chemistry.
- Prior experience in developing risk assessments, evaluating risk, and mitigating identified risks.
- CMO/CDMO experience preferred.
- Excellent communication skills.
If hired as Sr. Quality Specialist I the candidate should have experience with:
- Raw material test method evaluation and transfer.
- Raw material specifications and justifications review/approvals.
- Raw material and supplier qualification activities.
- Supplier audits, agreements, notifications, and changes.
- Provide data/information, write and review sections for regulatory filings.
- Provide data/information for customer requests and inquiries.
- Experience in both being audited and performing audits.