Quality Investigator

Actalent; Framingham (MA); On-site; Full time

Job summary

A leading company in engineering and sciences is seeking a Lead Investigator in Framingham, MA. This role involves leading investigations on quality control issues, performing root cause analyses, and ensuring compliance with regulatory standards. Ideal candidates have extensive GMP experience and relevant educational backgrounds, including degrees in Life Sciences or Engineering. The position requires onsite work from Monday to Friday and offers competitive pay and benefits.

Benefits

Medical, dental & vision

401(k) Retirement Plan

Life insurance

Short and long-term disability

Employee Assistance Program

Qualifications

• Minimum 8–10 years of experience in a GMP-regulated environment.
• At least 5–7 years focused on deviation management and investigations.
• Mentor junior investigators and provide training on techniques.

Responsibilities

• Lead and manage investigations related to deviations and non-conformances.
• Facilitate cross-functional meetings focused on investigations.
• Support regulatory inspections by presenting documentation.

Skills

Quality assurance

Deviation management

Root cause analysis

CAPA development

Knowledge of cGMP

Education

Bachelor’s or Master’s degree in Life Sciences

Pharmacy

Chemistry

Engineering

Tools

TrackWise

Job description

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Job Description

Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform thorough root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure accurate, complete, and timely investigation reports. Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations. Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress.

Job Description

Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory operations. Perform thorough root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure accurate, complete, and timely investigation reports. Drive the closure of investigations and deviations in accordance with internal procedures and regulatory expectations. Facilitate and lead cross-functional team meetings focused on deviation management and investigation progress.

Responsibilities

• Author and review investigation reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness.
• Monitor and track investigation metrics to identify systemic issues and recommend process improvements.
• Support regulatory inspections and internal audits by presenting investigation documentation and participating in discussions with auditors.
• Mentor junior investigators and provide training on investigation techniques and quality system requirements.
  
  

Essential Skills

• Expertise in quality assurance and deviation management.
• Proficiency in root cause analysis and CAPA development.
• Strong knowledge of cGMP, ICH Q10, FDA, EMA, and other global regulatory requirements.
• Minimum 8–10 years of experience in a GMP-regulated pharmaceutical or biotechnology environment, with at least 5–7 years focused on deviation management and investigations.
  
  

Additional Skills & Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field.
• Proficiency in quality systems software, such as TrackWise, is preferred.
  
  

Work Environment

The role requires working Monday through Friday, 100% onsite in Framingham, MA.

Pay and Benefits

The pay range for this position is $65.00 - $85.00/hr.

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)
  
  

Workplace Type

This is a fully onsite position in Framingham,MA.

Application Deadline

This position is anticipated to close on Jun 26, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Other, Information Technology, and Management

• Industries

  Business Consulting and Services

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