Principal Quality Auditor - Aseptic cGMP
FPCNational - New Jersey

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Principal Quality Auditor sought to observe and correct on the floor processes at our global biopharmaceutical and medical device client.

Initial Top Challenges:
1) Develop and roll out a new QA on-the-floor program
2) Function as Quality Audits champion and lead auditing with a focus on:
a. Clean room environments
b. Training and effectiveness audits
c. Facilities, Metrology, Labeling and Document Control, Change Control, Lot Disposition, Microbiology, Warehousing & Logistics, Manufacturing, Management Controls and Supplier Quality
d. Develop improvements for deficiencies identified
3) Coach and direct auditors supporting your department
4) Improve audit data collection, trending and metrics and regularly present to company leaders.

Salary : Base will be dependent on your expertise and should range up to the 90’s. Bonus eligible too.
Travel Estimate: Less than 10%
Location : New Jersey
Contact : Apply below and/or at and/or contact Ira Mann at

Qualifications :
1) 5+ years of pharmaceutical or medical device experience with at least 3 recent years being in an aseptic manufacturing.
2) BS Degree in Life Science or Engineering
3) Strong and documented audit experience including OTF (on the floor)

Preferences :
1) Training and effectiveness auditing
2) Lead Auditor Certification
3) Excellent leadership skills and the ability to influence

Key Words: auditing, on-the-floor, on the floor, OTF, training and effectiveness, sterile, aseptic, clean room, metrics

FPCNational - 21 months ago - save job - copy to clipboard