Overview
Quality Assurance Associate Jobs in Tewksbury, Massachusetts, USA at Cambridge Isotope Laboratories, Inc.
Position: Quality Assurance Associate I
Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Assurance Associate I based onsite in our Tewksbury, MA facility. CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL’s growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries 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. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.
The Quality Assurance Associate I is responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components in a GMP/ISO Environment.
Responsibilities:
Perform the review and release of product, including batch record review, review of Quality Control results, Certificate of Analysis creation.
Perform room/line clearances, creation of logbooks and controlled forms and form reconciliations, label review, final inspections.
Review and release of raw materials.
Support CIL’s change control process by helping with the initiation of change control, tracking of documents, and final distribution of the approved documents.
Support the performance of other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPA’s, document/data review and other administrative duties as needed.
Requirements:
Bachelor’s degree in a scientific or quality-related discipline.
Minimum of 0-2 years of experience with Quality Assurance.
Familiarity and/or experience in a GMP environment, along with knowledge of ICH Q7, ISO 17025, and ISO 13485, is a plus.
Must possess strong organizational skills and have a high attention to detail.
Excellent verbal, written, and interpersonal communication skills.
Some travel between Tewksbury, MA and Andover, MA facilities is required as this position supports both locations.
CIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.
Cambridge Isotope Laboratories is an Equal Opportunity Employer.
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Title: Quality Assurance Associate
Company: Cambridge Isotope Laboratories, Inc.
Location: Tewksbury, Massachusetts, USA
Category: Quality Assurance – QA/QC, Healthcare
