Director of Quality Assurance
Location: Cedar Bluffs Nebraska
Description: Sterling Life Sciences is currently interviewing Director of Quality Assurance right now, this occupation will be placed in Nebraska. More details about this occupation opportunity please read the description below. Partial Job Description
1) Establishing and maintaining the Quality Management System in accordance to FDA cGMP and other applicable requirements.
2) Est! ablish the corporate quality goals and metrics; create and implement the strategic quality plans.
3) Serve as primary contact for correspondence with FDA regulatory agency representatives.
4) Establish the Quality Manual, SOP?s, forms, protocols and ensure personnel training to execute the quality plan.
5) Foster and facilitate continuous improvement culture and efforts throughout the organization. Establish change control process to implement continuous improvement.
6) Establish and implement the certification, calibration, qualification, validation and auditing programs.
7) Develop and execute the process control systems, drive and monitor the implementation of these systems, and monitor the process to assure compliancy.
8) Supervise material, component, and product handling for approvals, releases, quarantines, reprocessing, and rejections.
9) Develop, establish and execute non-conforming and related systems ! including; failures, deviations, OOS, investigations, CAPA, va! riances that may arise in the course of manufacturing or distributing regulated articles.
10) Review production records to assure documentation meets cGMP requirements. Track and investigate errors which occur during production or QC.
11) Maintain an active, cross-functional approach to investigations, problem resolution, corrective and preventative actions in close collaboration with manufacturing, materials management, R&D.
12) Perform, direct and lead all duties associated with Quality Assurance department responsibilities.More questions? Want to know the Salary range? Keep reading. The best way to get more details is to click 'Apply', upload your resume, and ENTER YOUR QUESTIONS in the 'Cover Letter' field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL - we respect your privacy. Our Recruiters are more likely to respond to your questions if they know ! you are *seriously* interested, and prefer to know a little bit about your background before calling.Another Tip: Don't worry about whether you are 'qualified' or not. If this job looks interesting, apply. To hit a homerun, you need to swing the bat, right?Think about it: If you are a fit, our Recruiters will call and share more information. If you are not a fit, you still win: our Recruiters might see another opportunity that is perfect for you! And even if our Recruiters *do not* call, you still win - because you've improved your visibility with one of the most prestigious recruiting firms in the country!Bottom line: our Recruiters want to help you secure your dream job, and if we can help you, we will.TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Pfizer, Merck, Amgen, Genentech, Healthc! are, Life Sciences, Scientist, R&D, Ferring, Stryker, Boston Scientific! , Medtronic, Abraxis, Gilead, Glaxosmithkline, Clinical Research, Clinical Trial, Regulatory Affairs, FDA, Johnson & Johnson, Schering, Nutraceutical, Surgeon, MD, Hospital, Immunology, Medimmune, Abbott, Roche, Therapeutic, Hospira, Covidien, Quintiles, PPD, Parexel, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility
Qualifications / Skills Required
1) Bachelor's Degree in a Life or Physical Science or 5+ years of experience in the field.
2) Prior FDA cGMP and/or Medical Device experience preferred.
3) Strong communication skills.
4) 2+ years of managerial experience.
5) Biologics or biotech experience a plus but not necessary.
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If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Sterling Life Sciences.
If you interested on this occupation just click on the Apply button, you will be redirected to the official website
This occupation starts available on: Thu, 28 Mar 2013 10:03:44 GMT