Quality Control Analyst I – Pharmaceutical Operations (s

  • Contract Duration: 12+ months
  • Manufacturing
  • Framingham, MA

Website Lenox Executive Search

1 Year Contract – Framingham, MA

Strong Earnings Opportunity

Must be Vaccinated

Job Description:

· The Quality Control department supports the Seprafilm (medical device) and Sodium Hyaluronate (active pharmaceutical ingredient) GMP operations.

· The department performs analytical testing on intermediate, in process and final product materials using a variety of equipment to include GC, FTIR, UVVIS, and physical property instrumentation.

· Supports Biosurgery Business by performing in-process, stability, and release testing for Biosurgery Product lines.

Core Responsibilities:

· Perform Assays in accordance with SOPs for release, stability, and in-process samples.

· Review peer data including data transcription, data calculation and log entries.

· Lab general duties including cleaning, glassware, washing etc. Initiate DCR when assigned.

· Train on all documents assigned to training plan and complete training as assigned.

· Receive, verify, and log incoming samples.

· Participate in audits.

· Perform PM calibration on lab equipment.

· Conduct Safety and weekly compliance walkthroughs.

· Responsible for adherence to policies, procedures, and SOPs

· Participate in Lab Investigations.

· Perform OOS Investigations as Analyst.

· Adhere to site Quality and Safety Policies.

· Work towards accomplishment of Site Goals.

· QC testing of in-process, stability, and release samples in a GMP lab

· Support lab operations.

· Participate in lab meetings.

· Perform or Participate in Equipment Qualifications.

· Participate in bringing in new equipment (spec, URS, etc.)

· Early troubleshooting of assay/equipment issues.

· COA Filing and Sample Disposal.

· Coordinator Roles that can be assigned: Monthly Log Changes. Documentation Controls Reserves Metrology Purchasing Assay Occasion Tracking Data backup

Basic Qualifications:

· Bachelor’s Degree or equivalent in science. 0-2 years lab experience.

· Preferred Qualifications:

· Experience in laboratory techniques such as but not limited to pH, GC, UV/VIS and FTIR.

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