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QA Packaging Senior Specialist

Company: myGwork
Location: Coppell
Posted on: March 19, 2023

Job Description:

KEY ACCOUNTABILITIES: * Provide QA oversight of aseptic processing including QA audit program
* Execute personnel monitoring within the aseptic processing area using MODA system
* Execute AQL sampling and inspection of finished drug product
* Conduct real time review of batch records, logbooks, and other associated GMP documents
* Assist quality investigations related to deviations and environmental monitoring excursions
* Accountable for maintaining training compliance including training seasonal staff
* Demonstrates ability to work independently and within a team environment
* Possesses strong computer skills and familiarity with quality systems such as TrackWise
* Support additional site and quality functions, including but not limited to: o Change Control o SOP creation and revision o Validation documentation review o Site Wide Projects o Trend reporting * Supervise seasonal staff e.g. day to day work load and time sheet approval
* Investigate deviations related to production operations
* Prepare validation protocols and reports
* Apply risk based decision making to solve complex problems
* Act as a delegate to the Manager of QA OTF
* Provide leadership to others within and outside of the QA function
* Lead projects related to Quality and Production initiatives MINIMUM QUALIFICATIONS: * Bachelor of Science Degree
* 5 years of experience in bio-pharmaceutical or pharmaceutical industry
* GMP experience in a QA role
* Flexibility to work shifts as business needs

DESIRABLE QUALIFICATIONS: * Commercial Packaging experience
* Technical writing skills
* Project management skills
* Operational Excellence / Lean Manufacturing knowledge Salary : Negotiable This employer is a corporate member of
myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, Dallas , QA Packaging Senior Specialist, Other , Coppell, Texas

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