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 Sr. Specialist – CAPA and Investigations.


The Senior QA Specialist, QA Investigations/CAPA is an individual contributor role primarily responsible for conducting technical quality compliance related activities in accordance with GxP regulations and internal SOP. This SME ensures deviations are thoroughly investigated, root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or SISPQ.  Additionally, the individual is responsible for the oversight and communication of critical metrics regarding deviations and CAPAs.  The individual also provides QA review and oversight of Trend Review Reports to identify interrelationships between process inputs and critical process parameters and to identify process shifts. 

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

575 Children's Crossroads

Columbus, OH 43215 

 

Under the guidance and direction of the Quality Assurance Manager, Compliance, essential functions of the Senior QA Specialist, QA Investigations/CAPA include at a minimum:

  • Oversee and support the prompt evaluation, investigation, closure, and follow-up of unplanned events as well as identify opportunities for continuous improvements.
  • Works with SMEs to ensure thorough root cause analyses, assess impact to SISPQ, and ensures root cause is addressed through appropriate Corrective/Preventive Actions.
  • Works to establish appropriate ownership and timelines for CAPAs about the risk related to the event or issue.
  • Assesses final supporting documentation to complete/close CAPAs as adequate.  Conducts CAPA effectiveness checks for high-risk events.
  • Communicates critical metrics regarding deviations and CAPAs and chairs the Investigation Review Board meeting. 
  • Provides oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
  • Acts as the SME and trainer for TrackWise Investigation/CAPA module.
  • Prepares and reports quality metrics as necessary to ensure upper management is aware of trends and ongoing activities relevant to investigations, CAPA, etc.
  • Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
  • Assess accuracy and compliance of procedures as a SOP author, reviewer and approver and work with cross functional approval panels for timely, accurate document revisions.
  • Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
  • Performs function of Senior QA Specialist and other related assignments and duties as required and assigned.

 

Knowledge, Skills and Abilities required:

  • Minimum of 8 years’ experience GMP/Biopharmaceutical/Biotech Industry, 3-5 years specific QA on experience in a pharmaceutical environment, cell and gene therapy experience preferred.
  • Bachelor’s Degree in a technical or scientific discipline or equivalent
  • Operational knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
  • Demonstrated Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
  • Excellent verbal and written communication skills to all levels of the organization. Technical writing required.
  • Experience with the authoring and execution of Quality documentation including SOPs, CAPAs, Investigations.
  • Experience with FDA, EMA inspection interaction.
  • Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict and collaborate.
  • Must demonstrate a “can-do” attitude. 
  • Proficient in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint). Knowledge of application software such as Trackwise, SAP, preferred.

 

 

Minimum Physical Requirements

  • There are very minimal physical requirements. 
  • One needs to be able to lift 20-30 pounds occasionally, bend, reach or balance (0-33% of the time).
  • Requires ability to aseptically gown or wear other PPE required as needed.
  • Must be able to stand for extended periods.

 

 

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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