Quality Specialist II

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

Benefits offered by this job

Medical, dental & vision

401(k) Plan Pre-tax & Roth

Life Insurance

Disability (short/long-term)

HSA

Job summary

Actalent is seeking a Quality Assurance professional to review batch records, assess product disposition, and ensure release readiness for biopharmaceutical programs. The role requires an advanced degree or a bachelor’s with experience in a regulated environment, with strong cGMP knowledge and cross-functional collaboration.

You will evaluate manufacturing data, support CAPA and change controls, and communicate decisions clearly to Manufacturing, Regulatory Affairs, and QC teams.

Qualifications

• Advanced degree plus 2 years of experience or Bachelor's plus 3 years in Quality Assurance/Quality Control within a regulated biopharmaceutical or biotechnology environment.
• Preferred fields include Life Sciences, Biology, Microbiology, Biochemistry, Chemistry, or Engineering.
• Strong knowledge of cGMP, regulatory expectations, and industry guidance for biologics/pharmaceutical manufacturing.
• Experience with batch record review/approval, product disposition, and manufacturing documentation for commercial and clinical products.
• Familiarity with deviation investigations, CAPA, change control, and risk assessment methodologies.
• Ability to evaluate product impact and make disposition decisions using manufacturing, testing, validation, and quality system data.
• Experience reviewing analytical testing results, environmental/process data, validation reports, and quality documentation to support release decisions.
• Knowledge of manufacturing processes, aseptic operations, upstream/downstream processing, and/or fill-finish operations preferred.
• Experience with TrackWise, Veeva, SAP, LIMS, document management, and electronic batch record platforms.
• Strong technical writing and documentation review skills; ability to document quality decisions clearly.
• Excellent attention to detail; identify discrepancies and compliance risks.
• Strong problem-solving, critical-thinking, and risk-based decision-making skills.
• Ability to communicate quality requirements and disposition decisions to cross-functional stakeholders (Manufacturing, MSAT, QC, Supply Chain, Validation, Regulatory Affairs).
• Strong organizational skills to manage multiple disposition activities in a fast-paced environment.
• Ability to work independently with sound judgment within quality systems.
• Working knowledge of statistics, trending tools, and quality metrics.
• Experience supporting regulatory inspections and customer audits.
• Demonstrated GMP disposition decisions, including evaluation of batch record exceptions, deviations, change controls, lab results, and release documentation.

Responsibilities

• Review and approve batch records and disposition decisions for commercial and clinical products.
• Evaluate manufacturing documentation, testing data, and validation reports to support release.
• Manage deviation investigations, CAPAs, change controls, and risk assessments.
• Communicate quality requirements and disposition decisions to cross-functional partners.
• Ensure documentation is accurate, complete, and in compliance with regulatory standards.
• Support regulatory inspections and customer audits as needed.

Job description

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 [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.