Cambridge Isotope Laboratories, Inc. QA Batch Record Review Specialist in Tewksbury, Massachusetts
Cambridge Isotope Laboratories has an outstanding opportunity to enhance your career in the Quality Assurance (QA) field and be part of a team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components in our Tewksbury, MA location.
As the leading company in a niche scientific market, CIL works with cutting edge researchers in clinical diagnostics, metabolic research, proteomics, environmental testing, protein discovery, drug development, metabolomics and industrial research. CIL has had consistent growth and profitability for over 35 years. CIL's growing customer base spans academia, pharmaceutical and industry, enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth.
The QA Batch Record Review Specialist is responsible for the review and release of Batch Records, Certificates of Analysis and any additional relevant documentation. The QA Batch Record Review Specialist will frequently and effectively communicate the status of these documents to appropriate departments.
Review and release Batch Records, CoAs and any additional documentation required
Communicate accurate and up-to-date status reviews to appropriate personnel
Maintain the Finished Product Release database
Following cGMP and SOP procedures assist in the correction of deficiencies found within the documentation
Assist with the change control process
Perform other assigned duties as may be required in meeting company objectives
Bachelor’s in Chemistry or related science discipline
A minimum of 3-5 years of experience with Quality Assurance in a food or pharmaceutical setting
Must be detailed-oriented with excellent verbal and written communication skills, ability to coordinate multiple tasks efficiently
Strong interpersonal skills and the ability to work well in a team environment is a must
CIL offers a fantastic, comprehensive benefit program including Anthem Health, Dental, 6% matching 401K plan and sabbatical program. Sorry, we will not be providing relocation assistance for this position. Only local, New England area candidates need apply.
Learn more about us on our website: www.isotope.com
CIL is an EEO/Affirmative Action employer