Compliance Specialist
Atrium Staffing - Eatontown, NJ

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ID:
DDP/WCS

Type:
Direct Hire

Practice Area:
Scientific

Compensation:
Open DOE

Location:
New Jersey

Education:
Bachelor's Degree

City/Region:
Eatontown

Status:
Full Time

Our Client is one of the top 20 generic prescription medication providers in the US, providing pharmaceuticals to a growing number of chain stores and other vendors. They are looking to hire a Compliance Specialist in Eatontown, NJ. The Compliance Specialist role is a direct hire opportunity.

Responsibilities of Compliance Specialist:
Provide Compliance oversight in the development and improvement of manufacturing processes for existing and new products

To perform internal /external audits based on cGMP requirements

Provide review and support of Annual Product Reviews (APR’s)

Assist in development-approval of Process Validation/Qualifications IQ,OQ, and PQ

Monitor Quality Compliance program for quality issues and identify process improvements for assigned projects

Review/approve non-conforming materials and system documents

Review and approve non-conforming materials and system documentation

Review/approve product process change control documentation and specifications

Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of Business Process Excellence initiatives

Qualifications for Compliance Specialist:
College graduate or equivalent years of experience in Quality Compliance

Qualifications will include a detailed understanding of the cGMP and CFR’s

Working knowledge of FDA and international medical device regulations, and the application of Advanced Quality tools such as Failure Modes Effect analysis (FMEA), GD&T, SPC, Root Cause Analysis, Mistake Proofing/Poke-Yoke is preferred but not required

5-7 years in Quality Systems or Quality Compliance or applicable experience

Education Requirements:
Bachelors in a Science Discipline

About this company
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Founded in 1995, Atrium Staffing is a privately held, woman-owned staffing and recruitment firm with revenues grossing over $100M. Atrium...