Randstad Analyst in Northborough, Massachusetts
Northborough, MA Salary:
US$ 35 - US$ 47 per hour Date Posted:
Friday, October 7, 2016 Experience:
5 years Job Type:
A global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient s needs is looking for a Quality Control Analyst in the Northborough, MA area. This is a 5-month CONTRACT position, with the possibility of extension. No per diem available.
Responsibilities for the Analyst
Act as study director for validation of analytical methods and lab equipmentAuthor 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 Genzyme s safety procedures and guidelines. Maintain proficiency training per assigned curricula.
Requirements for the Analyst
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.
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.
Previous experience performing cGMP analytical analyses. Strong verbal and written skills. Previous experience with lab control operations and quality systemsPreferred experience with chromatography data systems (Empower) E.g. - FTIR, UV, UPLC-MS, GC, pH, KF, Autotitrator, ICP-MS,E.g. - Salts, acids, bases, resins
Job Number: 125922