It’s an exciting time to join us!

The Andelyn Biosciences’ Quality Assurance group is seeking a motivated individual to join our growing team as an QA Specialist.

The Quality Assurance (QA) Specialist supports the Clinical Manufacturing Facility by performing quality assurance functions for the maintenance of Quality records.   The QA Specialist will be responsible for ensuring compliance with Good Manufacturing Practices (cGMP) regulations, policies, and procedures applicable to these areas.  This position will report to the Quality Assurance Change Control/Operations Supervisor and will work closely with the Andelyn Biosciences staff.

 

Schedule: Full-time (Benefits Eligible) 

 

Location: Central Campus 

            700 Children's Drive

            Columbus, OH 43205 

 

Under the guidance and direction of the Quality Assurance Change Control/Operations Supervisor, essential functions of the Senior QA Documentation Specialist include at a minimum:

 

  • Maintain compliance with applicable regulatory and requirements for cellular and gene therapy products.
  • Coordinate the timely revision, review, approval, and management of GMP documents, including.
  • Batch Record and Quality Documentation Review
  • Maintenance of the databases/spreadsheets and keep up to date with tracking of change control records, deviation records, CAPA records and other documentation as required.
  • Assign document numbers, as required via the systems in place.
  • Upload completed documents to Training Management System and other systems, as required.
  • Assignment of Master Batch Record ID numbers and issuance of Batch Records and related forms for execution.
  • Works with the Operations team to track batch records throughout their lifecycle.
  • Reconciliation of batch records after they’ve been executed.
  • Act as a liaison between the QA and other departments to facilitate documentation revisions, implement Change Controls or CAPAs and to help identify potential issues
  • Assist the QA Change Control/Operations Supervisor with identifying areas for quality improvement and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
  • Responsible for reporting any deviations to procedures, specifications or systems to the Supervisor with logic, data and possible corrective measures.
  • Provide additional support as directed by Quality Assurance Management.

 

Knowledge, Skills, and Education required: 

  • Bachelor’s degree in scientific related discipline.
  • Minimum 1 years’ experience in working with GMP documentation  
  • Strong organizational skills and attention to detail
  • Working knowledge of cGxP, FDA and EU guidelines.
  • Ability to work in a fast-paced environment and prioritize workload.
  • Proficiency with applicable software (Trackwise, Microsoft Office, etc.) preferred
  • Travel requirements: 5%

 

Minimum Physical Requirements:

  • Sitting (Constantly)
  • Talking on the phone/in person (Constantly)
  • Typing on a computer keyboard (Constantly)
  • Standing/walking (Occasionally)
  • Lifting 45 lbs or greater (Frequently) 


The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

 

EOE M/F/Disability/Vet

 

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.

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