Pharma Prin QA Engineer

Medtronic. Careers with a passion for life.As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.
Pharma Prin QA Engineer
Minneapolis, MinnesotaThis position is responsible for the overall compliance of product, process and quality assurance activities for the development and commercial support of pharmaceuticals, biologics, and/or combination products. This position supports the enhancement and implementation of related quality systems, cGMP training and auditing programs, material, process and production controls, and all other aspects of quality assurance and quality control for the above mentioned products.
Responsibilities: Leads efforts in helping others understand cGMP and the QA department roles & responsibilities; provide Quality Assurance leadership in the development and continuation support of drugs, biologics, and combination projects. Specific quality assurance activities include, but are not limited to, the following: address gaps and ensure compliance to internal policies, procedures and regulations; management of CMO activities; conduct cGMP audits; support/conduct analytical method validation, process qualification and validation; support/conduct labeling and packaging activities; implement/perform annual product review and stability testing of drug products; maintain drug reserve sample program; lead CAPA and OOS investigations; conduct batch record review and lot disposition and develop drug specifications.
REQUIREMENTS
Requirements: Bachelor’s degree in chemistry, biochemistry, engineering, health care, biological sciences, or a related scientific discipline. Master’s degree preferred.
Must have 7+ Years of quality assurance or quality control experience in either the development or the commercial areas of pharmaceutical and/or combination products.Must have hands-on pharmaceutical GMP experience and a working knowledge of GLP and GCP.
Experience in CMC requirements.
Experience in auditing of suppliers to the pharmaceutical industry.
Technical understanding of pharmaceutical industry language and contracts.
Technical understanding of pharmaceutical formulations and processing.
Familiar with drug pharmaceutical ICH Guidelines, USP, JP, and ISO requirements.
Strong oral and written communication skills with a demonstrated ability to work in a team environment.Proven ability in coaching technical professionals to achieve maximum performance.
Proficient at influencing peers and senior management.
Ability to be flexible, multitask, and deliver on multiple projects simultaneously.
Proficient at creating pharmaceutical SOPs.
Proficient computer skills, including MS Word, MS Excel, MS-Powerpoint and MS-Outlook.
We are currently seeking multiple individuals for Regulatory Affairs & QA opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Minneapolis, Minnesota. Other opportunities may also exist at our locations in Northridge, California; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.
TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Regulatory Affairs openings or enter Requisition # 51506 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.
Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.