Quality Specialist II

The Quality Specialist II will support product disposition activities while ensuring compliance with established quality systems, cGMP requirements, and regulatory expectations. This role will collaborate with cross-functional teams to review manufacturing and quality documentation, assess product impact, investigate quality issues, and support product release decisions. The ideal candidate will have experience in a regulated biopharmaceutical, pharmaceutical, or biotechnology environment, with a strong skills in batch record review, product disposition, deviation investigations, and quality systems. Requirements Advanced degree plus 2 years of experience, or Bachelors degree plus 3 years of experience in Quality Assurance, Quality Control, Manufacturing, or a related function within a regulated biopharmaceutical, pharmaceutical, or biotechnology environment. Preferred fields of study include Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, Engineering, or a related technical discipline. Strong knowledge of cGMP regulations, regulatory expectations, and industry guidance applicable to biologics and pharmaceutical manufacturing. Experience performing batch record review and approval, product disposition, and assessment of manufacturing documentation for commercial and clinical products. Working knowledge of deviation investigations, CAPA management, change control systems, and risk assessment methodologies. Ability to evaluate product impact and make disposition decisions based on manufacturing, testing, validation, and quality system data. Experience reviewing and interpreting analytical testing results, environmental monitoring data, process monitoring data, validation reports, and quality documentation to support product release decisions. Knowledge of manufacturing processes, aseptic operations, upstream and downstream processing, and/or fill-finish operations preferred. Experience with electronic quality and enterprise systems such as TrackWise, Veeva, SAP, LIMS, document management systems, and electronic batch record platforms. Strong technical writing and documentation review skills with the ability to clearly document quality decisions and rationale. Excellent attention to detail with the ability to identify discrepancies, compliance risks, and potential product quality impacts. Strong problem-solving, critical-thinking, and risk-based decision-making skills. Ability to effectively communicate quality requirements and disposition decisions to cross-functional stakeholders, including Manufacturing, MSAT, QC, Supply Chain, Validation, and Regulatory Affairs. Strong organizational skills with the ability to manage multiple disposition activities and competing priorities in a fast-paced manufacturing environment. Ability to work independently while exercising sound judgment within established quality systems and procedures. Working knowledge of statistical concepts, trending tools, and quality metrics preferred. Experience supporting regulatory inspections and customer audits preferred. Demonstrated experience making GMP product disposition decisions, including evaluation of batch record exceptions, deviations, change controls, laboratory results, process monitoring data, product impact assessments, and completion of all required release documentation prior to disposition.
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)
Job Type & Location
This is a Contract position based out of Plainville, MA.
Application Deadline
This position is anticipated to close on Nov 19, 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 [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.