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Quality Specialist II

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Job Description

The Quality Specialist II serves as a key member of the quality organization and acts as the first line of defense for quality laboratories, while primarily working in a non-lab-based capacity. This role provides guidance to the labs, reviews batch records, and determines whether discrepancies can be resolved or must be escalated to the investigations team. The position operates within a robust Quality Management System supporting the manufacture of phase-appropriate materials for cellular and gene therapy products in a state-of-the-art facility.

Responsibilities

• Operate within the established Quality Management System that governs the manufacture of phase-appropriate material in the clinical manufacturing facility (CMF).
• Review batch records thoroughly to identify discrepancies, determine whether they can be remedied, and escalate issues to the investigations team when appropriate.
• Provide guidance and support to quality labs as the first line of defense for quality-related questions and issues, ensuring adherence to regulatory and internal standards.
• Ensure all product samples are correctly and clearly labeled, and document all aspects of sample allocation and transitions in the appropriate formats and systems.
• Maintain full accountability for product as it is allocated across different sample requirements and storage conditions, ensuring traceability and control.
• Evaluate processes associated with sample management to identify gaps, inefficiencies, or risks, and implement process improvements to enhance quality and compliance.
• Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs), maintaining accurate and audit-ready records.
• Maintain compliance with applicable regulatory requirements for cellular and gene therapy products, including adherence to GMP, cGMP, GLP, and other relevant quality standards.
• Perform tasks in accordance with established policies, procedures, and techniques, applying training, common experience, or working knowledge related to the activities performed.
• Work under the close supervision of sr staff and leadership, seeking guidance when needed while progressively building independence and expertise.
• Collaborate effectively in a diverse, cross-functional team environment, using clear and professional communication to support high productivity and shared goals.
• Document all activities performed in alignment with Good Manufacturing Practice (GMP), current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), and quality control (QC) expectations, including clean room activities, biological and molecular assays, technical writing, investigations, and CAPA-related work.
• Participate in cleanroom activities as required for a Quality Specialist II, while primarily performing desk-based review, documentation, and coordination tasks.
• Support backlog reduction efforts as needed, which may include optional weekend work to help the team meet operational timelines.

Essential Skills

• Bachelor’s degree (BS) in Biology or another relevant scientific field.
• Experience working in a highly regulated environment with strong documentation practices.
• Experience in an environment governed by formal quality systems, with a strong emphasis on compliance and traceability.
• Ability to operate within GMP, cGMP, GLP, or similar regulatory frameworks and apply these standards to daily work.
• Strong attention to detail and accuracy in documentation, labeling, and record-keeping.
• Capability to review batch records, identify discrepancies, and determine appropriate next steps, including remediation or escalation.
• Familiarity with sample management processes, including labeling, allocation, storage, and documentation.
• Ability to follow established policies, procedures, SOPs, and techniques consistently and reliably.
• Effective communication skills for working within diverse and collaborative cross-functional teams.
• Comfort working under close supervision while applying training and working knowledge to assigned tasks.
• Basic understanding of cleanroom practices and quality control concepts related to biology, molecular assays, and laboratory operations.
• Proficiency in technical documentation and record-keeping within a Quality Management System.

Additional Skills & Qualifications

• Highly preferred: Experience in a GMP manufacturing or quality environment, particularly in biopharmaceutical, cellular, or gene therapy settings.
• Experience in other highly regulated environments such as GLP laboratories or similar settings is considered valuable.
• Exposure to quality concepts such as QC, clean room operations, biological and molecular assays, technical writing, investigations, and CAPA (Corrective and Preventive Actions).
• Experience working in a startup or rapidly growing organization, with comfort adapting to evolving processes and systems.
• Demonstrated ability to identify process gaps in sample management or documentation workflows and contribute to continuous improvement.
• Strong organizational skills and the ability to manage multiple documentation and sample-related tasks simultaneously.
• Comfort working with cross-functional teams and interfacing with various stakeholders in quality, operations, and laboratory functions.

Work Environment

This role is based in a rapidly growing, state-of-the-art facility featuring modern cleanrooms and advanced equipment dedicated to cellular and gene therapy manufacturing. The organization is in an exciting startup phase and continues to expand, including the development of additional sites. The Quality Specialist II works almost entirely onsite, primarily in a desk-based setting, with cleanroom entry approximately two times per week. A typical day runs within a core schedule of roughly 8:00 a.m. to 5:00 p.m., with flexibility within that window to accommodate personal needs while maintaining a full 40-hour workweek. Work-from-home opportunities are rare but may occasionally be available for a Quality Specialist II when flexibility is needed. The role is part of a close-knit team of approximately 9–10 people, operating in cross-functional, collaborative groups. Weekend work (Saturday and Sunday) may be offered on a voluntary basis to help address backlog, and when accepted, it is performed in addition to the standard 40-hour workweek. The environment emphasizes cleanroom compliance, strong documentation practices, and adherence to GMP, cGMP, and GLP standards, with a professional dress code aligned to office and cleanroom requirements.

This is a Contract to Hire position based out of Columbus, OH.

The pay range for this position is $28.00 - $28.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Columbus,OH.

This position is anticipated to close on Sep 11, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.