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 a QA Operations Specialist II.

The QA Operations Specialist IIrole supports the Andelyn Corporate Center Manufacturing Facility by providing Quality Assurance oversight of Gene Therapy manufacturing processes. This position will be responsible for ensuring on the manufacturing floor compliance with current Good Manufacturing Practices (cGMP) regulations, policies, and procedures applicable to the Operations department.  The GMP On the Floor Specialist II reports to the GMP Supervisor of Quality Assurance.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Corporate Center (ACC)

                  1180 Arthur E. Adams Dr.

                  Columbus, OH 43221

 

Under the guidance and direction of the Supervisor, Quality Assurance, essential functions of the QA Operations Specialist II include at a minimum:

  • Maintain compliance with applicable regulatory requirements for gene therapy products
  • Operates within the Quality Management System applicable to the manufacture of phase appropriate materials in the Manufacturing Facility
  • Provides real time review of in-process batch documentation and associated data
  • Acts as the Quality expert on the production floor and will guide and advise Operations personnel on cGMPs and Good Documentation Practices (GDPs) to ensure timely reaction to issues
  • Conducts approval of pre-start-up activities including line/room clearance and initial equipment checks.
  • Consistently reviews in-process batch documentation to ensure real-time compliance to product specifications, cGMPs and GDPs, and company SOPs
  • Discusses errors directly with Operations personnel so corrections can be made if required
  • Reviews production logbooks for accuracy and compliance
  • Provides real-time guidance to Operations personnel pertaining to compliance to cGMPs by monitoring appropriate gowning for the production rooms in use, confirming the correct material and personnel flows are being followed, and ensuring aseptic techniques are applied as required
  • Assists the GMP Supervisor in identifying and supporting areas for continuous quality improvement (CAPA) and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives
  • Supports GMP product releases from the manufacturing facility by providing review of required documents as needed
  • Provide support to QA Management for third-party, client, and regulatory audits as needed
  • Provide additional support as directed by Quality Assurance Management

 

Knowledge, Skills and Abilities required:

  • Must possess Bachelor of Science degree, background in the life sciences, biotechnology or gene therapy industries preferred
  • Minimum of two (2) years experience in a regulated industry
  • Knowledge of aseptic processes in a cleanroom enviornment preferred
  • Excellent communication, organization, and project management skills with the ability to manage multiple tasks efficiently and adjust as priorities change
  • Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment
  • Attention to detail and ability to execute multiple tasks successfully
  • Must possess a client-focused mindset in daily tasks
  • Must possess prior experience handling confidential information and the ability to maintain confidentiality

 

Minimum Physical Requirements

  • Occasionally sitting/remaining in a seated position
  • Occasionally keyboarding
  • Frequently talking on the phone or in-person
  • Frequently standing or walking
  • Occasionally independently lifting up to 50 pounds

 

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.    

 

Andelyn Biosciences is committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

 

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties.

 

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