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QA Specialist I – 3rd Shift

Baudette, MN


QA Specialist I – 3rd Shift

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements. This includes, but is not limited to the following:

3rd Shift  – Sunday through Thursday – 11:15 pm to 7:15 am

Position Responsibilities:

Responsibilities include but are not limited to:

  • Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
  • Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
  • Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
  • Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
  • Perform other duties as assigned or requested.

About You

  • Bachelors degree in Chemistry, medical technology, microbiology or closely related field or major. 
  • Must have experience in an analytical laboratory, academic or otherwise.
  • Bachelors and/or post graduate education in Chemistry, Pharmacy or closely related field.
  • Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
  • Bachelors degree
  • 5 years experience working within Quality Assurance preferred
  • Must be able to Work the 3rd Shift – Sunday through Thursday 11:15 pm to 7:15 am
  • Computer skills
  • Previous work in a regulated environment
  • Problem solving skills
  • Ability to coordinate multiple tasks in a fast paced environment
  • Ability to read and follow procedures
  • Ability to work independently
  • Attention to detail
  • Excellent interpersonal skills
  • Excellent organizational and follow through skills
  • Excellent written and verbal communication skills
  • Knowledge of GMPs
  • Must be able to work within a team environment
  • Must be able to work possible shift changes
  • Must be able to travel occasionally