QC Specialist

Job Title: QC Specialist

Job Description

The QC Specialist will support Quality Control (QC) data management and provide oversight of Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). The role involves handling stability testing data and reviewing data trends using statistical software, managing certifications of analysis, material specifications, and reviewing other QC documentation. The specialist will also support method transfer, validation, and qualification activities while working in quality systems to manage Out of Specification (OOS), Out of Trend (OOT), deviations, investigations, change controls, and corrective and preventive actions (CAPAs).

Responsibilities

• Provide oversight and support for QC data management related to CMO/CTO.

• Handle and review stability testing data and analyze data trends using statistical software.

• Manage certifications of analysis, material specifications, and other QC documentation.

• Support method transfer, validation, and qualification activities.

• Work within quality systems to handle OOS/OOT, deviations, investigations, change controls, and CAPAs.

Essential Skills

• 5+ years of experience in life sciences and QC.

• 3+ years of quality control with CRO/CMO oversight.

• Proficiency in quality control, stability studies, method transfer, method validation, and quality systems.

• Familiarity with QMS systems and stability requirements.

Additional Skills & Qualifications

• Bachelor's degree in a relevant life science field.

• Experience with statistical software for data analysis.

• Knowledge of Veeva, MasterControl, and ZenQMS.

Work Environment

The QC Specialist will work in a hybrid schedule during normal business hours. This role provides an opportunity to contribute to several gene therapy programs and have direct oversight of CMO/CTO partners.

Job Type & Location

This is a Contract position based out of Charlestown, MA.

Pay and Benefits

The pay range for this position is $55.00 - $62.00/hr.

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 May 29, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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.