Quality Engineer III - Pro
2 days ago
Saint Louis
Job DescriptionJob Title: Quality Engineer III - Pro Job Description The Quality Engineer III plays a critical role in ensuring quality across the entire product lifecycle, from New Product Introduction (NPI) and Process Performance Qualification (PPQ) through to commercial manufacturing. This high-level individual contributor position provides phase-appropriate quality assurance oversight, supports technology transfer and process validation, and ensures programs are inspection-ready and aligned with commercialization quality strategies. The role collaborates closely with cross-functional teams to support successful product launches, ongoing commercial operations, and continuous improvement in a fast-paced biologics manufacturing environment. Responsibilities • Serve as the Quality representative and lead on cross-functional program teams to enable successful commercialization readiness from late-stage development through product launch and post-launch support., • Provide phase-appropriate quality assurance oversight for technology transfer, process validation and PPQ readiness, control strategy implementation, and manufacturing scale-up activities., • Partner with product and program leadership to ensure quality deliverables, timelines, and risk mitigations are integrated into program plans, including risk assessments, readiness reviews, and documentation strategies., • Ensure alignment with applicable regulations and guidance, including FDA, EMA, and ICH requirements, as well as site quality standards., • Review and approve GMP documentation such as batch records, standard operating procedures (SOPs), technical reports, and quality records, including work notifications., • Support material disposition and product release activities by applying sound quality principles and ensuring compliance with cGMP requirements., • Conduct compliance walkthroughs on the manufacturing floor to verify adherence to GMP standards and identify areas for improvement., • Provide on-floor QA oversight during manufacturing “hypercare” and critical operations to ensure processes are executed in a compliant and controlled manner., • Support and participate in investigations for deviations, corrective and preventive actions (CAPAs), and change controls, including root cause analysis and documentation., • Apply risk-based decision-making to drive compliant, effective, and practical quality outcomes across operations., • Identify, assess, and mitigate quality risks throughout the product lifecycle, escalating issues as appropriate and driving resolution., • Contribute to and lead continuous improvement initiatives related to quality systems, documentation, and manufacturing processes., • Utilize tools such as Smartsheet and other quality systems to manage documentation, track actions, and support inspection readiness., • Collaborate cross-functionally with manufacturing, process development, and other stakeholders to address quality and compliance issues and implement sustainable solutions., • Demonstrate independent decision-making by managing multiple priorities, making timely quality decisions under timeline pressure, and providing clear rationale to stakeholders., • Provide clear written and verbal communication to internal and external stakeholders, including documentation and explanation of quality decisions and regulatory expectations., • Support regulatory and technical reviews, including preparation for and participation in inspections and audits related to FDA and GMP requirements., • Maintain strong attention to detail in all quality-related activities, ensuring accuracy, completeness, and consistency of documentation and records., • Work in environmental clean rooms as needed, including aseptic gowning, to support on-floor QA oversight and validation activities.Essential Skills, • Bachelor’s degree in a scientific discipline or equivalent experience., • Typically 5+ years of experience in a regulated GMP manufacturing environment such as biopharmaceuticals, pharmaceuticals, medical devices, or similar, including direct Quality oversight., • Demonstrated experience supporting New Product Introduction (NPI), PPQ or PPI, and/or commercial manufacturing activities., • Strong knowledge of quality systems and their application in a GMP environment., • Experience with process validation and regulatory technical review, including FDA and GMP requirements., • Strong working knowledge of current Good Manufacturing Practices (cGMP), data integrity expectations, and inspection readiness., • Hands-on quality assurance experience in GMP environments, including on-floor QA oversight over manufacturing processes., • Proficiency in reviewing and approving SOPs, batch records, and other GMP documentation., • Experience with CAPAs, deviation investigations, change control, and root cause analysis., • Ability to apply risk-based decision-making in quality and compliance activities., • Effective written and verbal communication skills, including the ability to document and explain decisions to internal and external stakeholders., • Strong attention to detail and excellent organizational skills., • Proven ability to perform job functions with minimal guidance and manage multiple priorities in a fast-paced environment., • Demonstrated decision-making and leadership skills, including the ability to influence others and lead significant change., • Ability to work collaboratively with various departments and external partners to identify and implement solutions to address quality and compliance issues.Additional Skills & Qualifications, • Technical knowledge of biopharmaceutical manufacturing processes is desirable., • Experience with inspection, quality inspection, and audit activities in GMP environments., • Familiarity with GMP/FDA pharmaceutical quality assurance practices., • Experience with Smartsheet or similar tools for tracking quality activities and documentation., • Experience providing QA oversight during manufacturing “hypercare” and critical operations., • Ability to aseptically gown and work in environmental clean rooms, as needed., • Strong problem-solving abilities and a continuous improvement mindset., • Ability to influence cross-functional teams, manage competing priorities, and make sound quality decisions under timeline pressure., • Experience contributing to or leading continuous improvement initiatives related to quality systems and manufacturing processes.Work Environment This role is based at a fast-paced biologic drug substance manufacturing facility focused on cell process development to support clinical and commercial manufacturing. The site operates around the clock and employs a large workforce, supporting the production of therapies for chronic health conditions, including cancers and other life-threatening diseases. The organization is dedicated to advancing scientific research and discovery and is committed to enabling customers to make the world healthier, cleaner, and safer. The position typically follows a Monday–Friday schedule with a flexible start time, generally around 8:00 a.m. to 5:00 p.m. Work is primarily performed at a desk, with regular interaction on the manufacturing floor to support validation and QA oversight. The role requires the ability to gown up or down for work in controlled environments and clean rooms, including wearing full cleanroom attire such as “bunny suits” (whites) or blue garments similar to scrubs, as needed for process validation and on-floor QA activities. 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. 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 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 process due to a disability, please email 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.