JOB DESCRIPTION:

Our vision is creating future cell therapy miracles together.  We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine.  We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

ESSENTIAL FUNCTIONS AND RESPONSIBILITES:

• Schedules batch record process for all floor associates in accordance with kitting schedule.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• Provides technical expertise to the client services team on tech transfer activities.
• Provides supportive documents to investigators and/or compliance team.
• Conducts final verification of batch records prior to archiving; sends records to document control; Review of executed APS reports/ batch records.
• Draft SOPs, WIs, and Forms for revision.
• Supports QA teams with continuous improvements initiatives to enforce quality culture.
• Initiate change control as required.
• Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.
• Support walk thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.
• Other duties as assigned.

Supervisory Responsibilities

• Indirectly supervises QA Associates I and II within the Quality Assurance department
• Team lead for 2-3 QA Associates 1 & II

QUALIFICATIONS:

• Bachelor of Science in biological sciences or other relevant field of study
• Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics
• Experience in both clinical and commercial manufacturing is preferred.
• Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc.
• Experience in organizing teams for effective and timely completion of projects.
• Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
• Experience participating in or hosting health authority inspections and/or client audits.

ADDITIONAL QUALIFICATIONS:

• Relevant computer skills (Microsoft Office, Outlook)
• Detail-oriented and organized
• Analytical and problem-solving skills
• Good written and oral communication skills
• Ability to multi-task and be adaptable
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to work independently and with a team
• Strong Project Management and organization skills.

Minimum Required Training to Be Completed within the first 90 Days of hire

• GXP training
• SOP & WI training
• Safety Training

Working Environment

• Must have the ability to work in a team-oriented environment and with clients
• Must be able to work during the weekend, holidays and as required by the company
• May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
• Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.
• Understanding of quality system applications
• Must be able to handle the standard/moderate noise of the manufacturing facility.

Physical Requirements

• Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear
• The employee is frequently required to lift and/or move up to 30 pounds.

Other Duties

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.
• Duties, responsibilities, and activities may change at any time with or without notice.

MUST HAVE:

Bachelor of Science in biological sciences or other relevant field of study.

5 years of experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics.

Experience to handle the standard/moderate noise of the manufacturing facility.

Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents

NICE TO HAVE:

Relevant computer skills (Microsoft Office, Outlook)

Detail-oriented and organized, Analytical and problem-solving skills and good written and oral communication skills