Cambridge Isotope Laboratories, Inc. Quality Control Documentation Specialist in Andover, Massachusetts
Cambridge Isotope Laboratories has an outstanding opportunity to work as part of the Quality Control chemistry team in a fast-paced environment in our Andover, MA location with possible travel to/from our Tewksbury, MA location.
CIL and Cambridge Isotope Separations (CIS) are subsidiaries of the Otsuka Pharmaceutical Group. As the leading company in a niche scientific market, CIL works with customers across many high-tech industries including pharmaceutical, semiconductor, medical diagnostic, display and basic research. CIL partners with leading instrument manufacturers as well as with pioneering research groups that have expertise in product development and who drive market growth.
The QC Documentation Specialist is responsible for performing the data review for the release of regulated and/or non-regulated materials including raw materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs). The QC Documentation Specialist also compiles data for documentation of test procedures, performs investigations, and prepares reports.
Review data for release of GMP/ISO and/or non-regulated materials
Follow documented procedures
Document test data as required
Write test procedures and SOPs as required
Perform investigations as required
Prepare reports as required
BS degree in Chemistry, Chemistry Informatics or other relevant science degree
3 or more years of relevant industry experience (GC,GC/MS, NMR or HPLC experience a plus)
GMP and/or ISO experience preferred
Hands-on experience with Biovia LES/LIMS system strongly preferred
Must be able to handle multiple tasks, take initiative, follow through
Must possess strong verbal and written communication skills
Must be able to work effectively independently and as part of a team
CIL offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with 100% company paid deductibles, Long Term Incentives and 6% matching 401K plan.
CIL is an EEO/Affirmative Action employer.