Compliance Specialist II (Manufacturing/Quality) 1st Shift

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality) 1st Shift. This is a 12 months contract opportunity with long-term potential and is located in Framingham, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-95404

Pay Range: $35 - $44/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• 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.

Key Requirements and Technology Experience: 

• Inspection experience
• Previous pharma experience
• investigating experience
• deviation
• Internal Audit
• complaint or complaint investigation
• Local candidates only; free parking onsite
• No extensions noted at this time.
• *Gowning is required*
• No extreme hot cold conditions
• Ability to gown up as required for role
• Min Education Bachelor's degree
• 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
• Years of Experience: 3 - 6 Years
• Minimum Education: Bachelors Degree

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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