Job Title: Quality Engineer II
Job Description
The Quality Engineer II is a quality assurance professional with substantial experience in quality or manufacturing within a highly regulated industry. This role focuses on evaluating production processes and performance in a biologic drug substance manufacturing environment, driving quality improvements to existing processes and supporting the development of new processes that enhance efficiency, productivity, and product quality. The position supports manufacturing by providing real-time quality oversight on the production floor, initiating and managing deviations, and performing compliance inspections to ensure the consistent production and release of high-quality bulk drug substance for clinical and commercial use. Approximately 80% of the time is spent on the manufacturing floor observing operations and ensuring adherence to SOPs and batch records, while the remaining 20% is dedicated to desk-based quality document review and deviation management.
Responsibilities
Provide on-floor quality oversight of manufacturing processes, spending approximately 80% of time in production areas to observe operations and ensure adherence to SOPs, batch records, and established aseptic practices.
Oversee manufacturing activities and provide quality assurance perspective and input to support the production of compliant bulk drug substance.
Collaborate with cross-functional teams to develop, optimize, and improve processes that enhance efficiency, productivity, and product quality.
Conduct thorough audits and inspections to ensure sustained compliance with cGMP regulations, internal procedures, and industry standards in preparation for internal quality audits, client audits, and regulatory inspections.
Observe aseptic practices in real time and provide immediate coaching to colleagues to prevent contamination and cross-contamination.
Participate in client and regulatory audits as a subject matter expert on Fit and Finish, Changeover, and Change Control procedures and practices.
Observe critical process steps to assure adherence to guiding procedures, batch records, and aseptic techniques, and be available to manufacturing and process engineering teams for real-time quality support.
Perform daily GEMBA walks in all active manufacturing areas and other scheduled areas within the core, providing immediate feedback to colleagues and area management to ensure compliance with cGMPs, site procedures, and regulatory requirements.
Perform QA approval of suite and equipment changeover between client processes to ensure readiness and compliance before manufacturing activities resume.
Review autoclave logbooks, identify issues, and facilitate corrections to maintain accurate and compliant sterilization records.
Conduct Fit and Finish inspections according to risk assessments and guiding procedures to ensure the facility and equipment meet quality standards.
Perform monthly aseptic observations of critical activities carried out in Biosafety Cabinets to verify proper aseptic technique and compliance.
Attend and actively participate in manufacturing and QA huddles (Tier 1) to support communication, issue resolution, and continuous improvement.
Act as a Quality Management Representative as needed, supporting quality initiatives and representing quality interests in cross-functional discussions.
Take proactive actions to develop personal knowledge and skills related to quality practices, regulations, and manufacturing processes.
Complete all required training in a timely manner and maintain training records in accordance with quality and regulatory expectations.
Provide training, coaching, and mentorship to new and less experienced team members on quality standards, procedures, and effective quality strategies.
Qualify new team members to perform tasks that require Quality Subject Matter Expert (QSME) training, ensuring competency and compliance.
Write and review deviations in TrackWise or similar investigational writing systems, ensuring clear root cause analysis and effective corrective and preventive actions.
Author, revise, and review procedures in electronic document management systems (eDMS) to maintain accurate, clear, and compliant documentation.
Write and implement CAPAs as needed to address deviations, audit findings, and process improvements, and monitor their effectiveness.
Conduct and participate in investigation interviews and RAPIDs as required to gather information, determine root causes, and support resolution of quality issues.
Obtain buy-in and cooperation from operations and other stakeholders to resolve issues and maintain a strong quality culture and standards without direct authority, using tact and diplomacy with internal and external customers.
Essential Skills
Bachelor's degree (BA/BS) in Life Sciences such as biology, chemistry, biochemistry, or another science-related field combined with a minimum of three (3) years of relevant experience in a highly regulated manufacturing or quality environment.
Alternatively, a non-science degree combined with a minimum of seven (7) years of directly related work experience in biopharmaceutical manufacturing.
Substantial prior experience working within a Quality or Manufacturing organization in a highly regulated industry.
Demonstrated quality assurance experience in GMP/FDA-regulated pharmaceutical or biopharmaceutical environments.
Strong knowledge of quality practices, cGMP regulations, and international health authority guidelines.
Experience providing on-floor QA oversight over manufacturing processes, including observation of aseptic practices and batch execution.
Hands-on experience with CAPA management, including writing, implementing, and monitoring corrective and preventive actions.
Proficiency with SOPs and batch records, including batch record review and documentation of manufacturing activities.
Experience with investigational writing software systems such as TrackWise for deviations and investigations.
Ability to perform root cause analysis using established tools and methodologies in support of deviation investigations.
Technical writing skills with the ability to author, revise, and review procedures in document management software (eDMS).
Excellent problem-solving and analytical skills, with the ability to interpret data, identify trends, and recommend improvements.
Ability to obtain cooperation and drive a quality culture across operations without direct authority, using strong interpersonal and communication skills.
Physical ability to lift a minimum of 25 lbs independently and stand for approximately 80% of the shift.
Ability to meet cleanroom gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves and full gowning suits.
Additional Skills & Qualifications
Cleanroom manufacturing experience is highly preferred, including comfort with full ISO 5 and ISO 7 gowning requirements.
Understanding of the underlying rationale behind processes and practices, focusing on the 'why' as well as the 'how'.
Experience with tech transfer activities in a biopharmaceutical or biologics manufacturing environment is a plus.
Familiarity with Lean Manufacturing and Six Sigma methodologies is a plus, including participation in process improvement initiatives.
Experience using tools such as Smartsheet for tracking, documentation, or project coordination is beneficial.
Strong ability to coach, mentor, and qualify new team members on quality standards and QSME-required tasks.
Comfort working in a fast-paced, 24/7 biologic drug substance manufacturing environment that supports clinical and commercial production.
Ability to communicate clearly and diplomatically with internal and external stakeholders during audits, investigations, and routine operations.
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 $33.00 - $38.46/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 Saint Louis,MO.
Application Deadline
This position is anticipated to close on Jul 28, 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 actalentaccommodation@actalentservices.com 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.
