Quality Specialist II

Actalent; Plainville (MA); On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical, dental & vision

5% 401(k) match or similar retirement

Life Insurance

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO/Vacation or Sick Leave

Job summary

Actalent, a global engineering and sciences services company, is seeking a Quality Specialist II to support product disposition in a biotech/pharma manufacturing setting. The role emphasizes adherence to cGMP regulations, quality systems, and regulatory requirements, with emphasis on documentation and batch record reviews.

The position involves cross‑functional partnering with Manufacturing, QC, MSAT, Validation, and Regulatory teams to support product release, investigations, CAPAs, and

Qualifications

• Advanced degree with 2+ years or Bachelor's with 3+ years in QA, QC, or GMP biotech/pharma environment
• Degree in Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, Engineering, or related field
• Strong knowledge of cGMPs, batch record review, product disposition, deviations, CAPAs, change controls, and risk assessments
• Experience reviewing analytical, validation, environmental monitoring, and process data to support release decisions
• Familiarity with aseptic manufacturing, upstream/downstream processing, or fill-finish operations preferred
• Experience with TrackWise, Veeva, SAP, LIMS, electronic batch records, and document management systems preferred
• Strong technical writing, problem-solving, communication, and organizational skills

Responsibilities

• Perform batch record review and product disposition for clinical and commercial products
• Review manufacturing, testing, validation, and quality documentation to support product release
• Investigate deviations, support CAPAs, change controls, and risk assessments
• Evaluate product impact using analytical, environmental monitoring, process, and validation data
• Partner with Manufacturing, QC, MSAT, Validation, Supply Chain, and Regulatory teams
• Support audits, inspections, and continuous improvement initiatives

Skills

QA knowledge

cGMP compliance

Analytical thinking

Documentation

Communication

Education

Bachelor's degree in Life Sciences or related field

Advanced degree in Life Sciences or related field

Tools

TrackWise

Veeva

SAP

LIMS

Electronic batch records

Document management systems

Job description

Job Description

We are seeking a Quality Specialist II to support product disposition and ensure compliance with cGMP regulations, quality systems, and regulatory requirements within a biotech/pharmaceutical manufacturing environment.

Key Responsibilities

• Perform batch record review and product disposition for clinical and commercial products
• Review manufacturing, testing, validation, and quality documentation to support product release
• Investigate deviations, support CAPAs, change controls, and risk assessments
• Evaluate product impact using analytical, environmental monitoring, process, and validation data
• Partner with Manufacturing, QC, MSAT, Validation, Supply Chain, and Regulatory teams
• Support audits, inspections, and continuous improvement initiatives

Qualifications

• Advanced degree with 2+ years, or Bachelor's degree with 3+ years of experience in QA, QC, Manufacturing, or a related GMP-regulated biotech/pharmaceutical environment
• Degree in Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, Engineering, or related field
• Strong knowledge of cGMPs, batch record review, product disposition, deviations, CAPAs, change controls, and risk assessments
• Experience reviewing analytical, validation, environmental monitoring, and process data to support release decisions
• Familiarity with aseptic manufacturing, upstream/downstream processing, or fill-finish operations preferred
• Experience with TrackWise, Veeva, SAP, LIMS, electronic batch records, and document management systems preferred
• Strong technical writing, problem-solving, communication, and organizational skills

Job Type & Location

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

Pay And Benefits

The pay range for this position is $45.00 - $45.00/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)

Application Deadline

This position is anticipated to close on Nov 20, 2026.

Workplace Type

This is a fully onsite position in Plainville,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 [e-mail] 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.