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Quality Systems Specialist

Education:
Bachelor’s degree in a scientific/technical discipline
Location:
Atlanta, GA 30318 US (Primary)
Career Level:
Experienced (Non-Manager)
Category:
Quality Systems
Job Type:
Full-time
Job Description:

The Quality Systems Specialist is responsible for the timely and accurate maintenance of vendor qualifications, complaints and adverse event investigations, and oversight of training in support of drug product development and production.

Essential Job Functions

  • Perform work activities in compliance with Company SOP’s and Work Instructions that govern vendor qualification, complaints, adverse events, and training.
  • Maintain current knowledge of FDA regulations and guidance related to vendor qualification, complaints, adverse events, and training.
  • Compile and maintain vendor qualification files, which includes DMF status information, manufacturing site information, proof of GMP conformance, and many other documents related to the raw material or component. This involves discussion with vendors, interpreting applicability of the documents, and coming to sound conclusions.
  • Initiate testing of components, where applicable, which will involve internal and external communication with labs, submitting samples, and reviewing results for completeness.
  • Investigate vendor complaints, product complaints and adverse events, including communications with the customer, report writing, and follow through to closure.
  • Track and assist in the training of personnel related to Mikart SOPs and Work Instructions through specialized software and paper documents, where needed.
  • Track and assist in the training of personnel related to Mikart SOPs and Work Instructions through specialized software and paper documents, where needed.
  • Maintain, be the SME, and have ownership of the overall Mikart Training program. This includes responsibility for the upkeep and accuracy of data in the software used to track training through development and continuous improvement of the overall Mikart training program.

Key Characteristics

  • The individual selected for this role must be independent and will require to accomplish assigned tasks, only resorting to issue escalation when completely necessary.
  • Team player.
  • Reliable and organized.
  • Strong attention to detail, high concern for standards, and results oriented.
  • Excellent communication skills (oral and written).
  • Flexible work hours.

Physical Demands

  • Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
  • Walking, sitting, standing for long periods, and repetitive hand motions.
  • Occasional heavy lifting or moving required.
  • This role will be based in Atlanta. Periodic traveling to visit vendors may be required.

 

 

Job Requirements:
  • Bachelor’s degree in a scientific/technical discipline or equivalent mix of education and experience required.
  • Mastery of the English language and excellent communication oral and written skills are required.
  • Experience with computer systems, particularly Microsoft Office, and basic typing skills are required. Experience with Trackwise Digital is preferred.
  • One to five years of experience in a cGMP environment is preferred, depending on Specialist level.
Apply and Submit Resume/CV.