Compliance Specialist II

Job Description

Title : - Compliance Specialist II (1st Shift)

Location : Framingham, MA

Duration : Contract until Dec 2026 (Possible extension)

Description : Onsite Role

• Gowning is required

No extreme hot cold conditions

Ability to gown up as required for role

Min Education Bachelor's degree

Must Have skills : - Minimum of 2 years of experience in GMP, can be in quality, manufacturing. - Must have inspection experience process, must have previous experience inspection of in process and finished goods. - Previous pharma experience. Experience investigating experience with deviations.

Nice to Have : SAP experience, managing complaint or complaint investigation, or experience acquiring data in LIMS, Veeva

Team WILL work last week of December, during year end shut down

1st Shift : Perform audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation. Establish auditing requirements, quality standards and test methods in accordance with regulations and relevant quality requirements. Conduct internal audits of manufacturing processes to ensure compliance. Conduct review of testing results. Review document and complete inspection of returned goods. May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control. Interpret complex, explicit documentation to ensure quality standards and compliance. May provide training to new employees. Work under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contribute to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify. Frequent internal company and external contacts. Represent organization on specific projects. Years of Experience : 3 - 6 Years

Minimum Education : Bachelors Degree

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

E Minakshi.sangwan@aequor.com