Seeking QA associate director to act as lead on internal audits and QA responsibilities in an ISO environment.

Shall:

*** Develop and execute internal and external audit prep plans for FDA and EU regulatory inspections.
 
*** Facilitate internal and external audits, assessments, partner audits and regulatory inspections for GMP, GCP and CLP.

*** Create and maintain documents supporting regulatory filings.

*** Maintain and adhere to US codes of federal regulations for injectable drug delivery systems.

Requires at least 7 years experience in a QA role for a medical device or drug delivery manufacturer or similar and in-depth understanding of regulatory requirements for injectable drugs and injectable drug delivery systems.

Join a company focused on the future. Offering extremely generous employment packages including company match 401(k), extensive perquisites, and the ability to work with award winning, Ivy League professionals, in an environment that strives to stay on the cutting edge of science and technology.

For complete details contact Steven Alan Bernknopf at:
(609) 584-9000 ext 282

Or submit resume online at:
http://dmc9.com/sab/app.asp

Or email to:
1000011405_10007289@cand693seek.com

Please reference #34101 when responding. 
 
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: St. Paul
Job State Location: MN
Job Country Location: USA
Salary Range: $90,000 to $125,000

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: Http://najobbank.com Www.najobbank.com Top 10 Job Site Top 10 Career Site Pharmaceuticals Pre-filled Injectables Principal Quality Assurance Engineer Product Development Parenteral Dosage Forms Senior Quality Assurance Engineer Injectable M.S. MS Mechanical Parenteral Injectable Intravenous Intra-muscular Injectable Dosage Form Insulin Pen EpiPen Senior Design Engineer Self-Administration Drug Injection Systems Drug Delivery Devices Injectables Lead Medical Devices Auto Injectors Engineering EU FDA Quality Assurance Manager Regulatory Affairs Manager

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