Manufacturing Compliance Specialist - Astrix : Job Details

Our client, a leading biopharma company, is seeking a talented Manufacturing Compliance Specialist to help develop innovative treatments for chronic diseases!

Shift: Monday-Friday (1st Shift)

Pay: $26.00/hr. - $32.00/hr.

Type: 69-month contract (could extend longer, but project based)

Summary

The Manufacturing Compliance Specialist establishes, monitors, and maintains GMP systems for the OSD manufacturing processes. Reporting to the Manager of Manufacturing.

Responsibilities

• Review completed GMP documentation to ensure it is complete and accurate in preparation for product release.
• Work with the Solid Oral Dose team to proactively identify and resolve GMP non-compliance issues in the Manufacturing group (Materials, Engineering, Production).
• Write or revise (as required) SOPs and other GMP documentation supporting new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
• Coordinate (expedite when required) the approval process for GMP documentation between Manufacturing, QA, QC, and Development.
• Assure the resolution of deviation corrective actions, action items from Change Control systems, and any audit non-compliance items.
• Participate in audits by internal as well as external groups and agencies.
• Provide support in document preparation related to regulatory filings, validations, and new product introduction.

Qualifications

• Bachelors degree in scientific discipline or equivalent experience
• Minimum three years experience in Quality Assurance or manufacturing in the pharmaceutical or medical device industry
• Experience executing and reviewing Good Documentation Practices.

Physical Requirements

• Ability to lift/move 40 lbs. overhead.
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment.
• Ability to gown correctly for clean room manufacturing operations.
• Ability to stand or sit for extended periods (up to 4 hours at a time).
• Must be able to work in an office and a manufacturing environment.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!