GMP Quality Control Scientist II (2nd Shift)

Andelyn Biosciences, Inc•Columbus, OH

About The Position

The GMP Quality Control Scientist supports daily operations of the GMP QC laboratory and helps 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 role supports day-to-day laboratory operations, project and timeline management, materials management, laboratory investigations, SOP generation and revision, and assay performance. The position follows applicable regulatory practices, analytical methods, and GMP Standard Operating Procedures. The role operates within the Quality Management System for phase-appropriate material manufacturing in the CMF and maintains compliance with regulatory requirements for cellular and gene therapy products. It provides and reviews laboratory data for in-process, release, and stability testing; supports external laboratory shipments and communications; and assists with investigations, deviations, out-of-specification results, change controls, SOP revisions, and remediation. The Scientist also contributes to continuous improvement and adoption of new projects and technologies, responds to relevant storage-unit alarm notifications during assigned periods of responsibility, and documents work according to SOPs. The position performs assigned tasks under the general supervision of senior staff and leadership, using established procedures and exercising discretion, judgment, integrity, attention to detail, and personal responsibility. It requires clear communication, collaboration, and the ability to identify problems and adapt to team and project needs.

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.

Nice To Haves

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

Responsibilities

Operate within the Quality Management System applicable to manufacturing phase-appropriate material in the CMF.
Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
Collaborate with QC Management and senior QC staff on GMP area strategy, schedules, project timelines, and 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 in coordination with the QC Supervisor.
Assist with laboratory investigations, QC portions of deviation investigations, out-of-specification results, process change controls, SOP revisions, and remediation.
Collaborate with QC Management and senior QC staff to identify and meet continuous improvement objectives using metrics and statistical methods.
Collaborate with QC Management and senior QC staff to identify new projects and technologies for incorporation into the GMP area.
Respond to and take action on alarm notifications from applicable monitoring systems for laboratory temperature-controlled storage units during assigned periods of responsibility.
Document all activities according to SOPs.
Perform assigned tasks under established policies, procedures, and techniques; identify problems and make decisions based on established procedures.
Work collaboratively and communicate clearly in a diverse team environment to support productivity and team goals.
Perform other duties as assigned.

Benefits

Competitive compensation.
Medical, dental, and vision insurance plans eligible from 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.