Quality Control Specialist II - Documentation

Andelyn Biosciences, Inc • Columbus, OH

2d

About The Position

The Quality Control Specialist II – Documentation is an individual contributor who provides compliance and quality-improvement support to Andelyn’s Quality Control department. Working with QC management and senior staff, the role conducts data review and administrative work that supports the quality management program and helps ensure compliance with applicable regulations, policies, and procedures. The Specialist also supports quality- and process-improvement initiatives.

The role reviews QC data for release, stability, and client-specific projects; supports analytical data-review timelines; reviews documents and manufacturers’ Certificates of Analysis to assess raw-material suitability; and assists with material release. It also supports controlled documents in the eQMS, including change controls, and helps with investigations, deviations, CAPA, validation documents, and other QC laboratory documentation.

The Specialist monitors quality-system data for trends, reports quality issues, assists management with improvement plans and metrics, supports audits, and serves as a subject-matter expert for QC processes and procedures. The role may mentor junior staff, work with some independence, and perform other assigned duties. Activities must be documented according to SOPs, and work must comply with applicable regulatory requirements for cellular and gene therapy products.

Requirements

• Relevant four-year degree, relevant master’s degree, or relevant PhD.
• Three years of relevant experience with a four-year degree, or two years of relevant experience with a master’s degree.
• Experience in biologics or gene therapy.
• Excellent communication, organization, and project-management skills, including the ability to manage multiple projects and adjust as priorities change.
• High skill in Microsoft Office, including PowerPoint, Excel, and Word, as well as data interpretation and reporting.
• Ability to work independently and collaboratively in a diverse and inclusive work environment.
• Client-focused mindset in daily work.
• Prior experience handling confidential information and ability to maintain confidentiality.

Nice To Haves

• Experience in a highly regulated field.
• Knowledge of FDA regulatory requirements.
• Understanding of aseptic processes.

Responsibilities

• Operate within the Quality Management System applicable to manufacturing phase-appropriate material in the CMF.
• Collaborate with QC supervisors, managers, and senior staff on the strategic direction of the Quality Control department.
• Review Quality Control data for release, stability, and client-specific projects.
• Support the QC team in meeting analytical data-review timelines.
• Represent QC on continuous-improvement committees or working groups and use process-improvement tools to guide the work.
• Review relevant documents and manufacturers’ Certificates of Analysis to determine raw-material suitability for manufacturing use.
• Assist with QC support for change controls and other controlled documents in the eQMS.
• Review Quality Systems data for trends in assigned areas and report findings to Functional Area Management and QA; provide quality-improvement training to staff as needed.
• Perform QC functions, including product-release data review, starting-material data review and release, and stability report generation and data review.
• Identify quality issues and report them to senior QC staff and management.
• Support material release by assessing the suitability of production materials.
• Help QC management identify quality-improvement opportunities and develop action plans and metrics with senior staff.
• Assist with investigations, deviations, CAPA, validation documents, change control, and other QC laboratory documents.
• Serve as a subject-matter expert for QC processes and procedures and mentor junior QC staff as needed.
• Provide audit support.
• Document all activities according to SOPs and comply with applicable regulatory requirements for cellular and gene therapy products.
• Solve, correct, and prevent problems; perform assigned tasks and assign tasks to junior staff as needed.
• Plan and carry out work toward specific measurable objectives with little direct supervision, using established procedures to make decisions.
• Communicate clearly and contribute to a diverse, collaborative team environment and departmental goals.
• Travel infrequently and perform other duties as assigned.

Benefits

• Competitive compensation.
• Medical, dental, and vision insurance eligibility from day one; basic vision coverage is 100% company-paid.
• 160 hours of paid time off annually.
• 11 company-paid holidays and 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: Mid Level