Quality Specialist

Description

Author and maintain reference standard CoAs and specification documents. Plan, design, and oversee testing processes to ensure reference standards are fit for purpose and meet specifications (characterization, requalification, etc.). Coordinate with cross departmental to manage incoming new reference materials for upcoming projects. Manage logistics of reference material with contract lab, maintaining communication for characterization and testing. Perform both on-site and back-office audits of reference standard usage, documentation, and compliance with regulatory requirements (e.g., FDA, ICH, EU, ISO). Provide QC review of documentation, data accuracy, and regulatory compliance for reference standard-related processes Assist in training QC personnel on handling, documentation, and regulatory requirements for reference standards Act as liaison between Quality Control and other internal departments (AD, PM, MFG) as it relates to sample management, testing requirements, project documentation, and contract lab management Manage logistics of reference material with contract lab, maintaining communication for characterization and testing.

Skills

Quality control, chemistry, reference material, chemistry testing, characterization, COA, Gmp, FDA, ICH, EU, ISO

Top Skills Details

Quality control,chemistry,reference material,chemistry testing,characterization,COA

Additional Skills & Qualifications

BS in Chemistry (or related) with 5+ years in a GMP lab, or MS with 3+ years. Strong communication, collaboration, and attention to detail. Solid understanding of reference standard specifications and scheduling. Working knowledge of SQL, databases, and data integrity principles (ALCOA+). Understanding of Smartsheet and audit readiness.

Experience Level

Intermediate Level

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

The pay range for this position is $38.00 - $40.00/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 Contract position based out of Milford, MA.

This position is anticipated to close on Oct 30, 2026.

This is a fully onsite position in Milford,MA.

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 View email address on click.appcast.io 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.