Sr. Quality Specialist


Coventry, RI


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.


  • 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.

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