Quality Engineer III - Master Batch Records

Actalent; St. Louis (MO); On-site; USD 103,155,000 - 137,540,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Plan

Life Insurance

Disability

Health Savings Account

Transportation benefits

Employee Assistance Program

Paid time off

Job summary

Actalent in Saint Louis, MO, is seeking a Quality Engineer III to drive QA activities across NPI through PPQ and commercial manufacturing. You will spend substantial time on the floor, performing risk assessments, deviations, and review of Master Batch Records to ensure inspection readiness and regulatory alignment.

This role requires 5+ years in GMP environments, strong knowledge of cGMP and data integrity, and the ability to influence cross-functional teams.

Qualifications

• 5+ years in a regulated GMP manufacturing environment with QA oversight.
• Experience supporting clinical phases and/or commercial manufacturing.
• Strong knowledge of quality systems, deviations, risk assessment, and regulatory review.

Responsibilities

• Lead QA activities on cross-functional teams for commercialization readiness.
• Oversee technology transfer, PPQ readiness, control strategy, and scale-up.
• Ensure adherence to FDA/EMA/ICH guidance and site quality standards.
• Review GMP documents, batch records, SOPs, and quality records.
• Support material disposition, deviations, CAPAs, and change controls.

Skills

GMP manufacturing oversight

Quality oversight

Risk assessment

Master Batch Record review

cGMP / data integrity

Education

Bachelor’s degree in science

Job description

Job Title: Quality Engineer IIIJob Description

As a Quality Engineer III (QE III), you will play a critical role in supporting quality activities across the product lifecycle—from New Product Introduction (NPI) through Process Performance Qualification (PPQ) and into commercial manufacturing. This high-level individual contributor role is responsible for ensuring programs are compliant, inspection-ready, and aligned with commercialization quality strategies. You will collaborate cross-functionally to deliver high-quality outcomes that support successful product launches and sustained commercial operations. The role requires you to be on the floor for operations between 30-40% of the day, conducting risk assessments, managing deviations, reviewing Master Batch Records, and supporting documents.

Responsibilities

• Serve as Quality representative/lead on cross-functional program teams to enable successful commercialization readiness, from late-stage development through launch and post-launch support.

• Provide phase-appropriate QA oversight for technology transfer, process validation/PPQ readiness, control strategy implementation, and manufacturing scale-up activities.

• Partner with Product/Program Leadership to ensure quality deliverables, timelines, and risk mitigations are built into program plans, including risk assessments, readiness reviews, and documentation strategy.

• Ensure alignment to applicable regulations and guidance such as FDA, EMA, ICH, and site quality standards.

• Review and approve GMP documentation, including batch records, SOPs, technical reports, and quality records.

• Support material disposition and product release activities.

• Conduct compliance walkthroughs to ensure adherence to GMP standards.

• Provide QA support during manufacturing 'hypercare' and critical operations.

• Support investigations for deviations, CAPAs, and change controls.

• Apply risk-based decision-making to ensure compliant and effective outcomes.

• Identify, assess, and mitigate quality risks across operations.

• Contribute to continuous improvement initiatives.

Essential Skills

• 5+ years experience in a regulated GMP manufacturing environment, including Quality oversight.

• Experience supporting different pharmaceutical clinical phases and/or commercial manufacturing.

• Strong knowledge of quality systems, deviation management, and risk assessment.

• Master Batch Record review experience and regulatory technical review (FDA, GMP).

• Strong working knowledge of cGMP, data integrity expectations, and inspection readiness.

Additional Skills & Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience.

• Effective communication skills and attention to detail.

• Ability to influence cross-functionally and manage competing priorities.

• Proven ability to make key and timely decisions.

• Leadership skills and organizational abilities.

• Technical knowledge of biopharmaceutical manufacturing is desirable.

• Ability to aseptically gown and work in environmental clean rooms.

Work Environment

The St. Louis site is a fast-paced biologic drug substance manufacturing facility operating around the clock with approximately 1,000 employees. The facility focuses on cell process development to support clinical and commercial manufacturing. You will work Monday to Friday with flexible start times, typically 8am-5pm. The role requires 60% desk work and 30-40% on-floor operations, where you will need to gown up in a bunny suit or blues.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

Pay and Benefits

The pay range for this position is $36.00 - $48.00/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.

• 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 Saint Louis,MO.

Application Deadline

This position is anticipated to close on Oct 5, 2026.

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.