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 Supervisor, Investigations & CAPA.

The Quality Assurance Supervisor, Investigations & CAPA role is responsible for ensuring that all deviations and complaints are investigated in compliance with Good Manufacturing Practices (cGMP) regulations, policies, and procedures. This position reports to the QA Manager and will work closely with Andelyn Biosciences staff.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Central Campus 

575 Children's Crossroads

Columbus, OH 43215 

 

Under the guidance and direction of the Quality Assurance Compliance Manager, Compliance, essential functions of the Supervisor, Investigations & CAPA include at a minimum:

  • Lead and support investigations throughout the lifecycle of the product.
  • Manage staff of investigators on assessment of criticality, determination of affected processes, root cause analysis, assignment of Corrective & Preventative Action (CAPA).
  • Responsible for ensuring CAPAs are appropriate, are implemented as planned and have the intended effectiveness.
  • Lead cross-functional meetings to discuss findings of investigations and obtain resolution/commitments.
  • Perform data analysis and trending of deviation and complaint data to identify improvement opportunities and secure resources to drive continuous improvement across the organization.
  • Lead discussions with sponsors to communicate status of investigation, resolve issues, and recommend actions.
  • Accountable for working with problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
  • Author/revise Standard Operating Procedures (SOP) and supporting Work Instructions related to deviations and investigations.
  • Coach and train staff on the investigation process and root cause analysis.
  • Act as QA SME during sponsor and regulatory audits
  • Build upon and maintain the Andelyn investigation process.
  • Exercise discretion, judgment, and personal responsibility
  • Demonstrate high level of integrity
  • Maintain positive attitude
  • Attention to detail in all job functions
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed
  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
  • Work to specific measurable objectives requiring operational planning skill with little direct supervision
  • Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals
  • Developing and enforcing procedures and controls
  • Approval of procedures established by junior staff
  • Has budgetary responsibility
  • Moderate travel required
  • Frequent involvement in audits
  • Frequent involvement in customer relations
  • Significant responsibility for inspection outcomes
  • Responsible for hiring, development and related personnel processes
  • Mentoring and professional development of staff
  • Exercise crucial people skills
  • Ability to manage and influence people in direct and lateral support structure
  • Have significant latitude for making decisions for their operational or functional unit
  • Drives timelines and development through broad influence
  • Minimal interaction with legal services
  • Other duties as assigned

 

Knowledge, Skills and Abilities required:

  • Must possess relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred
  • Working knowledge of team function within the organization
  • First-level leadership.  Coordinates and leads daily team activities.  May spend a portion of time performing the work of those they supervise
  • Prior supervisory experience is preferred
  • Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change
  • Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
  • Experience with Trackwise is preferred.
  • Ability to work independently as well as collaboratively in a diverse and inclusive work environment
  • Must possess a client-focused mindset in daily tasks
  • Must possess prior experience handling confidential information and the ability to maintain confidentiality
  • Excellent detailed knowledge of cGMP, GLP, FDA guidelines

 

 

Minimum Physical Requirements

  • Sitting
  • Walking/Standing/Stooping
  • Independently lifting up to 50 pounds
  • Talking on phone or in person
  • Typing on a computer keyboard

 

 

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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