QA Operations Specialist I
Location:
Charlton, MA
Hours:
- Full time Monday to Friday in office
- Long term temp
Job Requirements:
*Bachelor’s degree Required
*2+ years of experience working in an FDA/EMA regulated environment
*Understanding of cGMP compliance and manufacturing operations
Duties:
- Complies and summarizes necessary information in support of Annual Product Reviews and/or Product Quality Reviews
- Provides QA compliance operational oversite and support for internal/external manufacturing operations including review and approval of protocols and reports, master batch records, executed batch records and QC data verifications.
- Coordinates, prepares and approves the release process documentation for products
- Assists with the management of deviations, change controls, corrective and preventive actions for operations: Provides support for Management Reviews
- Interfaces with Quality Control to assist and resolve compliance needs, OOS and Assay Validation needs.
- Active involvement in support of cGMP inspections from regulatory authorities.
- Effectively participates in Quality Assurance system process improvements and associated training as needed.
Pay Rate:
- $28-30/hour
. . . Pay Statement and Pay Transparency Laws: rate of pay listed is on a per hour basis. You will be entitled to health insurance once employed for 60 days and you must work 30 hours per week, on average, per month to enroll and maintain health insurance through Complete Staffing Solutions. Once both qualifiers are met you must complete the enrollment packet and your benefits will start on the first of the subsequent month. . . It is our policy to provide equal employment opportunity to all individuals regardless of race, color, sex, sexual orientation, religion, disability, age, veteran status, ancestry, national or ethnic origin or any other legally protected class. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. We are strongly committed to this policy, and believe in the concept and spirit of the law. #Indeed