Quality Analyst - 2nd Shift
Location: Saint Paul, MN
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 am
- 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
Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.