Randstad Quality Control in Waltham, Massachusetts

Quality Control


Waltham, MA

Date Posted:

Tuesday, October 11, 2016

Job Type:


Reference #:



Randstad Life Sciences

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Job Title: Quality Control Analyst III

Position Description

  • Act as study director for validation of analytical methods and lab equipment

  • Assess routine compendial updates for impact to existing testing procedures

  • Support development of junior analysts through mentoring

  • Practice safe work habits and adhere to Genzyme s safety procedures and guidelines

  • Maintain proficiency training per assigned curricula

Position Responsibilities

  • Author validation protocols / reports, test methods and records

  • Contribute scientific knowledge, analytical skills, and interpretation of data

  • Ensure a consistent style of QCRM documents to maintain quality and ease of review

  • Support analytical SOP method optimization, validation, transfer, and life cycle management

  • Support Out-of-Specification Investigations, CAPA events and Change Controls.

  • Support readiness for regulatory inspections and compliance audits.

Position Requirements

  • 1

Skills Required

An ideal candidate will have extensive analytical lab experience that can translate to method / instrument validation and document authoring. Emphasis will be placed on past analytical experience, with technical writing experience being a slightly lower position requirement.

  • Bachelor s degree in a related discipline

  • Minimum of 5 years of experience in cGMP laboratory environment

  • Hands-on experience with a broad range of lab equipment:

  • First-hand experience with compendial analysis of raw materials:

  • Previous experience performing cGMP analytical analyses.

  • Strong verbal and written skills

  • Previous experience with lab control operations and quality systems

  • Preferred experience with chromatography data systems (Empower)

  • E.g. - FTIR, UV, UPLC-MS, GC, pH, KF, Autotitrator, ICP-MS,

  • E.g. - Salts, acids, bases, resins

  • Bachelor s degree in a related discipline


  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

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