Sr. Quality Specialist

Job Description

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:

• Supplier/Materials
• 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.

Regulatory/Customers

• Provide data/information, write and review sections for regulatory filings.
• Provide data/information for customer requests and inquiries.

Auditing

• Experience in both being audited and performing audits.