Quality Specialist

Quality Control Specialist

We are seeking a detail-oriented Quality Control Specialist to support reference standard management programs within a GMP-regulated laboratory environment. This individual will play a critical role in ensuring reference materials are properly qualified, maintained, documented, and compliant with applicable regulatory standards.

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Key Responsibilities

- Author, review, and maintain Certificates of Analysis (CoAs), specifications, and supporting documentation for reference standards.
- Plan, coordinate, and oversee characterization, qualification, and requalification activities to ensure reference standards remain fit for purpose.
- Collaborate with cross-functional teams to manage incoming reference materials and support project timelines.
- Coordinate testing and characterization activities with external contract laboratories, serving as the primary point of contact throughout the process.
- Conduct on-site and remote audits related to reference standard usage, documentation, and regulatory compliance.
- Perform Quality Control reviews of data, documentation, and processes to ensure accuracy, completeness, and compliance with GMP requirements.
- Support training initiatives for QC personnel on reference standard handling, documentation practices, and compliance requirements.
- Act as a liaison between Quality Control and internal departments including Analytical Development, Project Management, and Manufacturing to support sample management, testing schedules, and project documentation.
- Maintain audit readiness and ensure adherence to applicable regulatory and quality standards.

Required Qualifications

- Bachelor's degree in Chemistry or a related scientific discipline with 5+ years of GMP laboratory experience, or a Master's degree with 3+ years of relevant experience.
- Strong knowledge of Quality Control processes within a regulated pharmaceutical, biotechnology, or life sciences environment.
- Experience managing reference standards, reference materials, specifications, and Certificates of Analysis (CoAs).
- Experience supporting characterization and testing activities for laboratory materials.
- Familiarity with FDA, ICH, EU, ISO, and GMP requirements.
- Strong attention to detail, organizational skills, and documentation practices.
- Excellent communication and cross-functional collaboration skills.

Preferred Qualifications

- Working knowledge of SQL, databases, and data integrity principles, including ALCOA+.
- Experience utilizing Smartsheet or similar project-tracking tools.
- Understanding of audit readiness and inspection support activities.
- Ability to manage multiple priorities in a fast-paced, regulated environment.

Job Type & Location This is a Contract position based out of Milford, MA.
Pay and Benefits
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)
Job Type & Location
This is a Contract position based out of Milford, MA.
Application Deadline
This position is anticipated to close on Nov 9, 2026.
Workplace Type
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 [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.