GMP Quality Control Scientist I (2nd Shift)

Andelyn Biosciences, Inc • Columbus, OH

8h

About The Position

The GMP Quality Control (QC) Scientist I performs assigned tasks supporting daily operations of the GMP QC laboratory. The role’s primary objective is to help ensure laboratory activities comply with applicable regulations, including 21 CFR Part 211 Subpart I and 21 CFR Part 11. Working with QC Management and senior QC staff, the Scientist I supports day-to-day laboratory operations, project and timeline management, materials management, investigations, SOP generation and revision, and assay performance. Assigned tasks must be performed in accordance with applicable regulatory practices, analytical methods, and GMP SOPs.

The Scientist I operates within the Quality Management System applicable to phase-appropriate manufacturing in the CMF and maintains compliance with requirements for cellular and gene therapy products. The position supports laboratory data handling and review, external laboratory coordination, investigations and change controls, continuous improvement, and consideration of new projects and technologies. The role also responds to alarm notifications for laboratory temperature-controlled storage units during the assigned period of responsibility.

The work is performed under the general supervision of senior staff and leadership, in a collaborative team environment. The role requires accurate SOP-based documentation, attention to detail, sound judgment, integrity, clear communication, and decisions based on established procedures. Other duties may be assigned.

Requirements

• Relevant four-year degree.
• Excellent communication, organization, and project management skills, including the ability to manage multiple projects and adjust as priorities change.
• Proficiency with Microsoft Office, including PowerPoint, Excel, and Word.
• Ability to work independently and collaboratively in a diverse and inclusive work environment.
• Client-focused mindset in daily tasks.
• Prior experience handling confidential information and ability to maintain confidentiality.
• Attention to detail, integrity, judgment, and ability to follow established policies, procedures, and techniques.

Nice To Haves

• Background in life sciences, biotechnology, or gene therapy industries.
• Experience in highly regulated fields.

Responsibilities

• Support daily operations of the GMP QC laboratory in compliance with applicable regulations, analytical methods, and GMP SOPs.
• Operate within the Quality Management System applicable to manufacturing phase-appropriate material in the CMF and maintain compliance with requirements for cellular and gene therapy products.
• Collaborate with QC Management and senior QC staff on strategic direction, schedules, project timelines, and laboratory capabilities.
• Provide QC Management with laboratory data from in-process, release, and stability testing; manage and review data compilation for correctness.
• Assist with shipments and communications involving external QC laboratories, coordinating with the QC Supervisor.
• Assist QC Management with laboratory investigations, QC aspects of deviation investigations, out-of-specification results, process change controls, SOP revisions, and remediation.
• Support identification and achievement of continuous improvement objectives using metrics and other statistical means.
• Assist in seeking new projects and technologies for incorporation into the GMP area.
• Respond to alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during the assigned period of responsibility.
• Document all activities according to SOPs and make decisions based on established procedures.
• Work collaboratively, communicate clearly, identify problems, and complete assigned tasks under the general supervision of senior staff and leadership.
• Perform other duties as assigned.

Benefits

• Competitive compensation.
• Medical, dental, and vision insurance eligibility beginning on day one; basic vision coverage is 100% company-paid.
• 160 hours of Paid Time Off annually.
• 11 company-paid holidays plus 2 floating holidays annually.
• Company-paid life insurance.
• 401(k) match.
• Company-paid short- and long-term disability.
• Four weeks of paid parental leave for birth and adoption.
• Adoption assistance.
• Tuition reimbursement and student loan repayment assistance.
• Company-paid LinkedIn Learning access.
• Employee Assistance Programs.
• Flexible work options, role specific.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level