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General Description

 

The QA Documentation Technician is an individual contributor role and supports the Manufacturing Facility by performing quality assurance functions for the maintenance of Quality records. This position will report to the QA Manager and will work closely with the manufacturing operations staff. The technician will 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

Principal Duties and Responsibilities

• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the manufacturing operations.

• Perform essential Document Control functions in a timely manner in order to support efficient functioning of the Manufacturing Facility, including but not limited to: registering controlled documents, monitoring and communicating revision and review cycles, and issuing production documents

• Assist with organizing and maintaining the QA Documents Room by scanning, filing, and archiving GMP records.

• Ensures that documentation is maintained following internal procedures and regulatory requirements.

• Supports an environment that fosters communication and teamwork within Quality Assurance and related departments.

• 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 job duties by following established policies, procedures, and techniques and requires training, common experience, or working knowledge related to the tasks performed.

• Works with senior staff to solve, correct, and prevent problems, and performs tasks as assigned by leadership.

• Work to specific measurable objectives requiring operational planning skills with little direct supervision.

• 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

• Minimal involvement in audits

• Infrequent travel required

• Minimal involvement in customer relations

• Minimal responsibility for inspection outcomes

• Other duties as assigned.

Knowledge, Skills, and Abilities Required

• Relevant two-year degree with a background in the life sciences, biotechnology, or gene therapy industries preferred.

• Experience in a highly regulated field is a plus.

• 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.

• 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)

• 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 the ability to handle confidential information and the ability to maintain confidentiality.

 Minimum Physical Requirements 

• Frequent sitting/remaining in a seated position.
• Occasionally independently lifting up to 50 pounds
• Occasionally talking on the phone or in-person
• Frequently keyboarding
•  Ability to wear PPE on an infrequent 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, 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.

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn.  If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemptions may be considered depending upon the specific job duties.