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Quality Assurance - Pharma

Company: Pace Life Sciences
Location: Saint Paul
Posted on: June 7, 2021

Job Description:

OVERVIEW

Candidate will work within the Quality Assurance (QA) group 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/manufacturing setting. This position is an active and project-oriented position. Every day can be different with changing responsibilities, priorities and personnel interactions.

RESPONSIBILITIES

  • Line clearances, batch record review, CAPA complaint handling, manufacturing orders, validation and stability protocols/documents, product specifications
  • Support manufacturing through timely process of deviations, change controls and investigations to ensure quality products
  • Conduct facility and/or supplier assessments and raw material release
  • Author and update SOPs as needed
  • Follow GMP guidelines and adhere to SOPs and GMP requirements
  • Communicate QA issues and statuses with QA, QC, and manufacturing personnel
  • Work on multiple projects with changing deadlines and priorities
  • Utilize MasterControl document management system

QUALIFICATIONS

  • BS in Chemistry or related science
  • with 2+ years of quality assurance/documentation review experience

  • Experience working in med device or pharmaceutical manufacturing environment 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
  • Willingness to support temporary 2nd shift operations as needed

About SPS at Pace Analytical

Our Scientific Professional Services division partners with companies that have scientific needs both inside and outside of the laboratory. We hire quality candidates for our lab and regulatory teams so that our customers have an elite workforce supporting their company. Our Scientific Recruiters are passionate about finding a position that is the right fit for you. We're proud to offer careers that are both challenging and meaningful- as well as a comprehensive benefits package to all of our regular, full-time employees. If you work with us, you'll be part of a dynamic team focused on delivering science better.

OFCCP Statement

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.

Keywords: Pace Life Sciences, St. Paul , Quality Assurance - Pharma, Other , Saint Paul, Minnesota

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