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 Specialist II – Quality Assurance – Quality Control Support.

The Quality Assurance (QA) Specialist II is an individual contributor role and provides compliance and quality improvement support to the Clinical Manufacturing Facility (CMF). This role will work in conjunction with QA Management to conduct Quality Control data review as well as administrative tasks to support the quality management program and to assure the CMF is compliant with applicable regulations, policies, and procedures. The QA Specialist II will support a variety of quality improvement and process improvement initiatives.  This position will report to the QA Manager – QC Support (GMP) and will work closely with the Clinical Manufacturing Facility 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 Manager – Quality Control Support, essential functions of the Quality Assurance Specialist II include at a minimum:

• Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.
• Review all Quality Control data in support of product release, stability, and client specific projects.
• QA SME for QC processes and procedures. Mentor and train junior QA staff as needed.
• Represent the QA group in continuous improvement committees or working groups. Incorporate process improvement tools to guide working groups.
• Assist with investigations, deviations, CAPA, validation documentation, change control and other related controlled documents for the Quality Control Laboratory.
• Review Quality Systems data for trends within assigned area of support and report to functional area management, QA, and provide quality improvement training for staff as needed.
• Perform QA functions related to Quality Control including process audits, document review and approval and final product disposition.
•  Routinely identify quality issues and report to senior QA staff and CMF management.
•  Provide support to QA Management for all internal third-party audits.
• Assist QA Management with identifying areas for quality improvement. Work with senior QA staff and management to develop action plans and metrics needed to monitor progress toward meeting quality improvement objectives.
• Provide additional support as directed by QA Management.

 

Knowledge, Skills and Abilities required:

• Relevant four-year degree
• 3 years’ experience (w/4 YR degree) in a quality control laboratory, quality assurance, or compliance.
• Knowledge of regulatory (FDA) requirements preferred.
• Excellent verbal and written communication skills required.
• Excellent computer skills required: Microsoft Office Suite, SharePoint.
• Ability and willingness to be compliant with procedures and regulations.
• Attention to detail and ability to execute multiple tasks and see them through to completion.
• Approximately 5% travel.

 

 

Minimum Physical Requirements

• Sitting:  Constantly (67-100%)                                                                             
• Talking on phone/in person:  Frequently (34-66%)                             
• Typing on a keyboard:  Constantly (67-100%)                                                                         
• Standing/walking:  Occasionally (0-33%)
• Lifting:  Frequently (34-66%)                    

 

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.