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Job Requirements of Compliance Specialist II- 1st Shift:
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Employment Type:
Contractor
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Location:
Framingham, MA (Onsite)
Do you meet the requirements for this job?
Compliance Specialist II- 1st Shift
Careers Integrated Resources Inc
Framingham, MA (Onsite)
Contractor
Title: Compliance Specialist II- 1st Shift
Location Framingham, MA (Onsite Role)
Duration: 12 Months+ Possible Extension
Manager Notes:
Location Framingham, MA (Onsite Role)
Duration: 12 Months+ Possible Extension
Manager Notes:
- 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 and experience with deviations.
- Nice to Have: SAP experience, managing complaint or complaint investigation, or experience acquiring data in LIMS, Veeva
- 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
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