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| Reference: |
2816 |
| Date Posted: |
4/21/2008 |
| Organization: |
Sterling-Hoffman Life Sciences |
| Employment Type: |
Full Time |
| Location: |
Melville, NY |
Description:
Our client is a world-leading healthcare company that has developed a reputation for successfully bringing impacting products to market in a variety of therapeutic areas. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work!
Job Responsibilities:
1) Prepare and conduct QA and QC audits of contract manufacturer’s issuance of reports to the management
2) Oversee the corrective action process for identified deficiencies
3) Research applicable FDA regulations, EU regulations, TGA, ISO and ASTM standards
4) Ensure (ongoing) compliance with recent changes
5) Create audit schedules for all audits
6) Communicate with auditors and the ones being audited
7) Ensure that audits are conducted within the established timeframe
Job Requirements:
1) BS in Pharmaceutical Sciences, Chemistry or a related field (MS preferred)
2) 7+ years of experience in QA and QC
3) Quality Auditor certification from ASQ, RAPS, ISO or an equivalent organization
4) Experience in conducting audits on a national as well as international level of distribution and manufacturing facilities
5) In-depth knowledge of FDA and EU standards, cGMPs, TGA, ISO as well as ASTM standards
6) Expertise in using computers (MS Word, Excel, Access and flow charts)
7) Ability to analyze problems and develop solutions
8) Ability to work independently
9) Excellent leadership skills
10) Keen attention to detail
11) Superb communication skills
Applicants are encouraged to apply directly by going to:http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-02816.html
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| Healthcare Field: |
Biotechnology |
| Category: |
Clinical Quality Assurance Auditor |
| SubCategory: |
None |
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Job Posted By:
Similee Harvey
Sterling-Hoffman Life Sciences
800 West El Camino Real ,Suite 180
Mountain View
United States
94040
View more jobs posted by Similee Harvey |