General Description

The Specialist II – Quality Assurance (Plasmids) role supports the Andelyn Plasmids Center Manufacturing Facility by providing Quality Assurance oversight of Plasmid manufacturing processes. This position will be responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) regulations, policies, and procedures applicable to the Operations (Plasmids) department.  The Specialist II – Quality Assurance (Plasmids) reports to the GMP Supervisor of Quality Assurance.

Schedule: Full-time (Benefits Eligible) 

Location:   Andelyn Corporate Center 

                   1180 Arthur E. Adams Dr.

                   Columbus, Ohio 43221

Principal Duties and Responsibilities

·       Maintain compliance with applicable regulatory requirements for gene therapy products

·       Operates within the Quality Management System applicable to the manufacture of phase appropriate materials the Manufacturing Facility

·       Provides day-to-day support to Plasmids Operations team so production timelines are met

·       Serves as QA support for cross-functional projects supporting manufacturing activities at the Andelyn Plasmids Center (APC)

·       Supports Master/Working Cell Bank and Plasmids product releases to meet target disposition dates  

·       Reviews and approves master and executed batch record documents

·       Conducts approval of pre-start-up activities including line/room clearance and initial equipment checks

·       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

·       Discusses errors directly with Plasmids Operations personnel so corrections can be made if required

·       Reviews production logbooks for accuracy and compliance

·       Assists the GMP Supervisor in identifying and supporting areas for continuous quality improvement and the development of action plans and metrics needed to monitor progress toward meeting quality improvement objectives

·       Supports GMP product releases from the manufacturing facility by providing review of required documents as needed

·       Provides additional support as directed by Quality Assurance Management

·      Works with Plasmids Operations to address client comments and/or questions related to batch records

·       Exercise discretion, judgment, and personal responsibility

·       Demonstrates a high level of integrity

·       Maintains a positive attitude

·       Attention to detail in all job functions is required

·       Documentation of all activities performed according to SOPs

·       Makes decisions based on established procedures

·       Infrequent travel may be required

·       Other duties as assigned   

Knowledge, Skills, and Abilities Required

·       Must possess a Bachelor of Science degree, a background in the life sciences, biotechnology or gene therapy industries preferred

·       Minimum of two (2) years experience in a regulated industry.

·       Knowledge of aseptic processes in a cleanroom environment is preferred.

·       Excellent communication, organization, and project management skills with the ability to manage multiple tasks 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.

·       Attention to detail and ability to execute multiple tasks successfully.

·       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

       

·        Frequent Sitting

·        Occasional Walking/Standing/Stooping

·        Frequent Talking on the phone or in-person

·        Frequent Typing on a computer keyboard

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.