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Protocol Link, Inc.

Contract: Deviation / Investigation Writer



Job Description
Minimum of Bachelor's Degree in Science, or related. Minimum of 5 to 7 years' experience in a Pharmaceutical Manufacturing facility working in operations, production, or quality, and a minimum of 3 years' experience in investigation writing in the Pharmaceutical industry.

Key Skills:
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Experience authoring investigations cover Out-of-Specification (OOS) results, Out-of-Tolerance (OOT) results, Media Fill failures, Manufacturing deviations, etc.
• Ability to conduct in-depth interviews and gather pertinent information to drive to root cause conclusions and initiations of CAPA actions, if required
• Exceptional writing and communication skills to clearly convey investigational findings







About Protocol Link, Inc.
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.


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Posted on February 4, 2013 at 8:04 am
Clean up your social media and get a job!
In a recent poll, 18 percent of employers reported finding content on social networking sites that caused them to hire or not hire a candidate.
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Posted on February 4, 2013 at 8:04 am
Clean up your social media and get a job!
In a recent poll, 18 percent of employers reported finding content on social networking sites that caused them to hire or not hire a candidate.
READ MORE >
Posted on February 4, 2013 at 8:04 am
Clean up your social media and get a job!
In a recent poll, 18 percent of employers reported finding content on social networking sites that caused them to hire or not hire a candidate.
READ MORE >
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