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 - Change Control
The Quality Assurance (QA) Specialist II is an individual contributor role and provides compliance and quality assurance support to the Clinical Manufacturing Facility (CMF). This position will report to the QA Manager 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, 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.
- Works closely with Operations colleagues to support activities that ensure control of clinical manufacturing and the facility.
- Track change controls within the Trackwise system.
- Responsible for the Change Control Review Board email distribution list and ensuring that it is kept current and updated, as needed.
- Act as the main point of contact for Change Controls and provide support to owners and approvers assigned in Trackwise.
- Assist in the development of action plans and metrics to monitor Change Management within the Andelyn QMS.
- Act as owner of the Change Management SOP. Revise, as needed to ensure compliancy with regulations and the Andelyn QMS.
- Additional tasks within QA, as assigned.
Knowledge, Skills and Abilities required:
- Bachelors Degree in Scientific Discipline
- 3 years’ experience in pharmaceutical manufacturing, quality, or compliance. Knowledge of microbiology, contamination control and aseptic processes preferred.
- Attention to detail and ability to execute multiple tasks and see thru to completion.
- 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; cell and gene therapy experience a plus
- Experience with the authoring, review and execution of Quality documentation including standard operating procedures
- Strong experience working in cross-functional team. Ability to influence, negotiate, manage conflict and collaborate.
- 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.
- Must demonstrate a “can-do” attitude.
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).
- 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.
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.