Quality Assurance Senior Specialist

Andelyn Biosciences is an industry leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their families. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, toxicology, clinical and commercial quality.

Schedule: Fulltime (Benefits Eligible)

Locations:

Andelyn Corporate Center

1180 Arthur E. Adams Drive

Columbus, OH 43221

Principal Duties and Responsibilities

The Quality Assurance Senior Specialist is responsible for planning and performing internal and external quality audits.

Scheduling, preparing, and performing internal and external audits to support GMP.

Assembling and coordinating the activities of the audit team, if needed.

Performing audits in accordance with Andelyn's standard operating procedures, quality policies, and GMP regulations.

Escalating compliance issues, as needed.

Communicating audit results to management and auditees through written audit reports.

Leading post-audit activities, following up on vital corrective and preventive actions by resolving issues.

Assisting with hosting facility inspections by acting as a scribe and/or document reviewer, as needed.

Drafting and issuing periodic reports to site management, as requested.

Assignment, tracking, and completion of CAPA activities associated with audits.

Assisting with training/orientation for new Quality Auditing staff.

Interpret policies, standards, and regulations, and then evaluate potentially critical problems not covered.

Maintain audit schedules to ensure compliance with internal SOPs. This will include contract organizations, suppliers and service providers, and internal audits of the Andelyn facility.

Knowledge, Skills, and Abilities Required

BA with at least three years of related experience in the Biotech/Pharmaceutical industry

At least five years of audit experience in a GMP environment is preferred.

Detailed-oriented; ability to track timelines and milestones.

Negotiation skills and ability to communicate with all levels of an organization.

Proficiency in developing and writing procedures, audit reports, and corrective action plans.

Experience in using Trackwise is preferred.

Ability to work with minimal supervision.

***Other Duties as assigned.

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

The above list of duties and minimum physical requirements 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, 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 based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.