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30 days old

Quality Assurance Manager- Pharmaceutical

Kelly Services
Austin, TX 78703
**Quality Assurance Manager - Pharmaceutical**



**Austin, TX**



The Quality Assurance Manager will provide QA oversight of manufacturing and laboratory operations and will work collaboratively with leadership, quality control and assurance. This position is responsible for assuring compliance to FDA regulations and will conduct self-inspections and internal audits. The role will develop programs and activities to ensure continued compliance with regulatory and company requirements under the QMS.



Responsibilities:



Provide quality oversight to all aspects of the manufacturing activities involving API and finished dosage form manufacturing



Execution and maintenance of the self-inspection program



Promote a high level of cGMP awareness and compliance.



Provide QA oversight and guidance for the development and implementation of SOP's



Approve GMP documentation, including SOPs, validation documentation, change controls and other controlled documents from business partner areas.



Responsible for quality investigations, customer complaints, vendor complaints and make recommendations for CAPA.



Liaise with regulatory during inspections and facilitate audit responses.



Participate in batch release activities and provide training to employees.



Implement the Quality Management System including, provide expertise and impact assessments.



Requirements:



Bachelor of Science in Chemistry or related field



5+ years of related experience in the pharmaceutical industry.



Strong GMP knowledge and familiar with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines.



Experience required in Regulatory/Quality Assurance project management; supervisory management experience preferred.



Experience in pharma manufacturing; API and/ or CDMO experience is preferred.




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-12-18 Expires: 2021-01-18

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Quality Assurance Manager- Pharmaceutical

Kelly Services
Austin, TX 78703

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