This position will report to the Site Quality Manager. The Quality Specialist evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements.  The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites.

 

Position Requirements:

  • Evaluate completed procedures were followed, product tests performed appropriately and acceptance criteria met.
  • Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures.
  • Ensure that the required initial and continuing training of personnel is carried out and adapted according to need
  • Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages
  • Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
  • Supporting or performing internal audits.
  • Supporting external regulatory or customer audits.
  • Supporting or performing supplier audits.
  • Gather information from multiple departments for trending and presentation to management.
  • Identify trends in the industry and recommend improvements
  • Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control
  • Other duties as assigned to ensure appropriate quality practices

 

Required Skills:

  • Knowledge and experience with the GMPs
  • Able to identify potential adverse issues
  • Excellent organization and documentation skills
  • Detail oriented
  • Computer skills, including Microsoft Word and Excel

 

Pay/Schedule:

  • $16.00 – $18.00/hour
  • 1st shift – 6am – 2pm
  • 2nd shift – 2pm – 10pm