From: Elise Martin <emartin@mutualtargetinc.com>
Date: Wed, Jan 6, 2016 at 8:47 AM
Subject: Position Description QA Compliance Official
To: paul.edith@gmail.com
Cc: emartin@mutualtargetinc.com, lwinchek@mutualtargetinc.com
Hello again Edith! Here is the description for a permanent position you may be interested in as QA Compliance Official for a Pharmaceutical / Biotech company located in Stillwater, PA. If you are not already working with another recruiter and have not applied directly to Sanofi in the last 6 months, please review the description and send me your most recent resume in Word file doc format. I will be contacting you with a few questions if you feel this position may be a good fit. Have a wonderful day meanwhile.
Thank you!
Elise Martin
(Sanofi) QA Compliance Official
Swiftwater, PA
QA Compliance Official
Position Summary:
Ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through formal QA Audits, investigations, training and recommendations to procedures.
Position Responsibilities:
Evaluate and provide Quality Assurance recommendations on all products, processes, systems and deficiencies that are/may be affected by regulatory or cGMP requirements
Ensure compliance with applicable regulatory requirements, to be in a constant state of inspection readiness
Complete incident investigations in response to any unexplained events encountered during manufacturing or out-of-specification lab results for functional areas
Provide input, guidance and recommendations to department management regarding results of investigation and process improvements
Provide cGMP audits of processing areas
Monitor observations and address all concerns
Key Competencies and Soft-Skills
Strong communication, interpersonal, teamwork and organization skills
A good understanding of vaccines/biologics products and associated technologies
Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
Who You Are
You are inspired and driven by the company mission to improve worldwide human health. You would fit in well with the values of innovation, solidarity, confidence, respect and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
Our company is an Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.
#LI-sp
Qualifications
Basic Qualifications:
•Bachelor's Degree in life sciences.
•Minimum 5 years' experience in a cGMP controlled/pharmaceutical industry (specific to Quality assurance experience)
Primary Location: United States-Pennsylvania-Swiftwater
Compensation
Base Salary - $80,000 to $95,000
Benefits - Full
Relocation Assistance Available - Yes
Commission Compensation - No
Bonus Eligible - Yes
Overtime Eligible - No
Interview Travel Reimbursed - Yes
Candidate Details
5+ to 7 years experience
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally
Additional Details
Location: Swiftwater
Industry: Pharmaceutical / Biotech
Job Category: Manufacturing - Quality
Hours Per Week:
Visa Candidate Considered: No
Elise Martin
Mutual Target Associates Recruiter
Office Hours 9am – 5pm CST
Phone: 646 467-6772
Posted by: Edith Paul <paul.edith@gmail.com>
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