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- Saint Paul, MN
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Quality Analyst - 2nd Shift
Pace Analytical • Saint Paul, MN
Posted 26 days ago
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Quality Anaylst - 'Quality Engineer Assistant'
Candidate will work with Quality Assurance as a Quality Engineer Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as reviewer and/or approver for required documentation in a pilot plant setting. This position is very project orientated, so the QE Assistant can expect every day to be different with changing responsibilities and priorities.
Hours: Monday-Thursday; 2nd shift 4 pm-2:30 amResponsibilities
- Review lab data, validation and stability protocols/documents, batch tickets, specifications, and manufacturing orders for compliance
- Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products
- Conduct facility and/or supplier assessments, raw material release, and line clearances
- Author and update SOPs as needed
- Follow GMP guidelines and adhere to SOPs and GMP requirements
- Communicate QA issues to employees and managers in a tactful manner
- Work on multiple projects at once with changing deadlines and priorities
- BS in Chemistry or related science
- 2+ years of applicable experience
- Experience working in a laboratory or process manufacturing setting preferred
- Experience working in a regulated environment (GMP) preferred
- Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure
- Strong verbal and written communication skills
- Technical writing and review ability
- Desire to work in an office setting as this position is not laboratory or engineering focused