QC Specialist

QC Specialist

Location: Hybrid (2-3 days onsite per week) Industry: Biotechnology / Gene Therapy
## About the Role
We are seeking an experienced QC Specialist to support quality control activities across multiple gene therapy programs. This individual will provide oversight of external testing and manufacturing partners, manage QC and stability data, support analytical method lifecycle activities, and ensure compliance with GMP and regulatory requirements. The ideal candidate will have a strong quality control experience within the life sciences industry, experience working with CMOs/CROs, and a solid understanding of stability programs, analytical methods, and quality systems.

Key Responsibilities

- Manage and review quality control data generated by external contract manufacturing and testing organizations.
- Perform detailed review of release and stability testing data to ensure accuracy, completeness, and regulatory compliance.
- Analyze and trend QC and stability data using tools such as JMP and GraphPad.
- Support and maintain product stability programs, including sample tracking, data review, and reporting.
- Draft, review, and maintain QC documentation, including SOPs, specifications, protocols, reports, and Certificates of Analysis.
- Collaborate with Analytical Development teams on method qualification, validation, transfer, and fit-for-purpose assessments.
- Support reference standard management activities and associated documentation.
- Initiate and manage quality records including deviations, OOS/OOT investigations, impact assessments, and change controls.
- Provide technical oversight of external manufacturing and testing partners to ensure quality and compliance expectations are met.
- Utilize electronic quality management systems (eQMS) such as Veeva, MasterControl, or ZenQMS.
- Partner cross-functionally with internal teams and external stakeholders to support program goals and continuous improvement initiatives.

Qualifications

Required

- Bachelor's degree in Biology, Chemistry, Biochemistry, or another Life Science discipline.
- 5+ years of experience in Quality Control within a regulated life sciences environment.
- 3+ years of experience overseeing external partners, CMOs, CROs, and/or contract testing organizations.
- Experience supporting analytical method transfers, method qualifications, and method validations.
- Strong understanding of GMP regulations and product testing requirements.
- Experience supporting stability studies, including sample management, data review, and reporting.
- Hands-on experience with investigations, deviations, change controls, OOS, and OOT events.
- Proficiency with data trending and statistical analysis tools such as JMP and GraphPad.
- Excellent organizational, documentation, and communication skills.

Preferred

- Experience supporting gene therapy, cell therapy, biologics, or other advanced therapeutic programs.
- Familiarity with ICH stability guidelines and analytical testing requirements.
- Experience with quality management systems including Veeva, MasterControl, or ZenQMS.
- Experience supporting reference standard programs.
- Previous experience within a GMP manufacturing, testing, or biopharmaceutical environment.

Why Join Us?

This is an exciting opportunity to contribute to innovative gene therapy programs while working alongside internal subject matter experts and external partners. The role offers a collaborative environment, exposure to advanced modalities, and the opportunity to play a key role in ensuring product quality and compliance throughout development and commercialization.
Job Type & Location
This is a Contract position based out of Charlestown, MA.
Pay and Benefits
The pay range for this position is $50.00 - $57.00/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)
Workplace Type
This is a hybrid position in Charlestown,MA.
Application Deadline
This position is anticipated to close on Oct 8, 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 without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

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

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall 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 applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.