QA Specialist

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Burlington, MA.

Job Responsibilities:

• Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's.
• Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
• Monitor Operations personnel for adherence to SOP's. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
• Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
• Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation

• Other duties as assigned

Skills and Requirements:

• Bachelor's degree in life science field required
• 4-6 years' experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 2 years' experience in Quality Assurance

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-BC1