Labeling Compliance Specialist Job

LABELING COMPLIANCE SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Bridgewater, New Jersey.

The Big Picture - Top Skills You Should Possess:
- QA Labeling experience
- Artwork review
- FDA regulatory experience

What You'll Be Doing:
- Maintain viability and integrity of US marketed products by conducting quality reviews of labeling artwork within the interdepartmental review process as follows:
- Provides timely review of labeling artwork to ensure final product labeling complies with FDA requirements and corporate standards
- Uses both manual (visual) and software-assisted methods to perform text comparison and assures that drafted art files faithfully reproduce FDA-approved text and meet accepted standards for layout
- Validates printer's proofs against approved artwork using text comparison software (AutoProof Pro), also uses visual methods when needed
- Gives final approval for implementation of artwork in Electronic Change Control System
- Participates in weekly interdepartmental labeling meetings and obtains consensus on labeling revisions and prioritization of labeling activities
- Discusses labeling corrections with other labeling review groups (for example, Legal, Supply Chain, Regulatory Affairs, and Marketing)
- Gains consensus on impact and urgency of labeling corrections, negotiates implementation, and tracks eventual resolution in artwork

What You Need to Bring to the Table:
- Bachelors Degree
- 10-15 Years experience
- Experience with QA labeling, cGMP, cGCP, Research compound/data management, Clinical trial data management, Regulatory/FDA guidelines

OPPORTUNITY IS CALLING, APPLY NOW!

Yoh, a DayJ2W: CLINICAL

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