Compliance Specialist I (Manufacturing/Quality) 1st Shift

1 Year

Framingham, MA

Shift: Monday- Friday 8am-5pm Occasional weekend required; 100% onsite

• Fully onsite Open to candidate willing to relocate at own expense.
• Assignment is firm at 1 year
• New hires will work with 7 other team members
• Free Parking onsite

Required:

Excel, MS Word

Minimum 1 year of GMP experience

Flexibility with schedule and managing priorities

organized, strong communications and strong computer literacy skills

Nice to Have/ Preferred:

Veeva, SAP

Batch record review experience in a compliance role

Previous experience, gowning in GMP facility (2-3 times per week required)

Job Description

Partner with manufacturing and support operations to ensure a culture of continuous compliance. Perform batch record review..

Job Responsibilities

• Perform quality inspections of intermediates and finished goods.

• Perform review of QC data.

• Perform logbook review.

• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations

• 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.

• Represent organization on specific projects.

Education & Qualifications

• High School Diploma

Must Have: -

•Batch record review experience in a compliance role

•Excel, MS Word

•Minimum 1 year of GMP experience

•Flexibility with schedule and managing priorities

•Organized, strong communications and strong computer literacy skills

Nice to Have/ Preferred:

•Veeva, SAP

•Previous experience, gowning in GMP facility (2-3 times per week required)