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.

The Senior Specialist, QA Operations is an individual contributor role and provides compliance and quality assurance support to the manufacturing operations. This position will report to the QA Supervisor and will work closely with the manufacturing operations staff to support internal Quality Assurance functions focused on GMP operations and associated quality systems, including change controls and internal process verification.

 

Schedule: Full-time (Benefits Eligible)  

Location:  Andelyn Corporate Center 

                  1180 Arthur E. Adams Dr.

                  Columbus, OH 43221

 

Under the guidance and direction of the Supervisor Quality Assurance, essential functions of the Sr. Specialist include at a minimum:

• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the manufacturing operations
• Serves as the QA lead for cross-functional projects supporting manufacturing activities at both the Andelyn Corporate Center (ACC) and Andelyn Plasmid Center (APC)
• Perform Environmental Monitoring trend review for the cleanroom spaces in ACC and APC
• Works closely with Operations colleagues to support activities that ensure control of clinical manufacturing and the facility
• Support Product Release to meet Target Disposition Dates  
• Review and approve master and executed batch records
• Observe manufacturing activities to support the implementation of best practices and improvements.
• Author and review procedures including Policies, Standard Operating Procedures, and Work Instructions, as assigned
• Ensures that documentation is maintained following internal procedures and regulatory requirements
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments
• Work with Manufacturing to address Client comments and/or questions related to batch records
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain a positive attitude
• Maintain compliance with applicable regulatory requirements for gene therapy products
• Attention to detail in all job functions
• Performs document review following established policies, procedures, and techniques and requires training, common experience, or working knowledge related to the tasks performed
• Solving, correcting, preventing problems, and performs tasks as assigned by leadership, as well as assigning tasks to junior staff
• Work to specific measurable objectives requiring operational planning skills with little direct supervision
• Leads and supports a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of team and goals
• Documentation of all activities performed according to SOPs
• Make decisions based on established procedures
• Has fiscal responsibility
• Infrequent travel required
• Moderate involvement in audits
• Moderate involvement in customer relations
• Moderate responsibility for inspection outcomes
• Influences hiring, development, and related personnel processes
• Mentoring and professional development of staff
• Other duties as assigned

 

Knowledge, Skills and Abilities required:

• Must possess relevant four-year degree OR relevant master’s OR relevant Ph.D., background in the life sciences, biotechnology, or gene therapy industries preferred
• Five years relevant (w/4 YR deg) OR two years (w/Masters)
• Experience in biologics or gene therapy required
• Experience in highly regulated field preferred
• Proficient 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, European Directives, ICH guidelines, and cGMP regulations
• Experience in commercial and clinical GMP production and ability to provide QA support for both
• Experience with aseptic manufacturing operations required.
• 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
• 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

 

Minimum Physical Requirements

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

 

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.