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Scientific. Clinical. Software Engineering

Quality Control Analyst

Boston Metro Area, MA

Job Type: Scientific Job Number: JN -062020-26957 Region: Boston Metro Area

Job Description

Position Summary

Supports Biosurgery Business by performing in-process, stability and release testing for

Biosurgery Product lines.

Core Responsibilities

Perform Assays in accordance with SOP s 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.

Is responsible for adherence to policies, procedures and SOP s

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.






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.

Special Working Conditions:

Requires working with hazardous chemicals.

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