Previous Job
Quality Control Analyst III
Ref No.: 18-09017
Location: Northborough, Massachusetts
Key Responsibilities:
Act as study director for validation of analytical methods and lab equipment
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.
Assess routine compendial updates for impact to existing testing procedures
Support development of junior analysts through mentoring
Practice safe work habits and adhere to Client's safety procedures and guidelines
Maintain proficiency training per assigned curricula

Basic Qualifications:
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