Job Title: Quality Engineer II

Job Description

The Quality Engineer II is a dedicated professional in quality assurance, possessing significant experience in a Quality or Manufacturing organization within a highly regulated industry. This role focuses on evaluating production processes and performance in manufacturing, aiming to engineer quality improvements in existing processes and develop new methods to enhance quality and efficiency. The position involves understanding contamination and cross-contamination, observing aseptic practices, conducting daily GEMBAs, assessing facility fit and finish, and performing compliance inspections within manufacturing areas. The role supports manufacturing by providing quality input and initiating deviations as identified, all contributing to the production and release of quality bulk drug substances for clinical and commercial use.

Responsibilities

• Oversee activities and provide QA-related input.
• Collaborate with cross-functional teams to optimize processes enhancing efficiency, productivity, and quality.
• Conduct thorough audits and inspections ensuring compliance with industry standards and regulations.
• Observe aseptic practices and coach site colleagues to prevent contamination.
• Participate as a subject matter expert in client and regulatory audits on Fit and Finish, Changeover, and Change Control procedures.
• Monitor critical process steps to ensure adherence to guiding procedures and aseptic practices.
• Perform GEMBA in active areas daily, providing feedback to ensure compliance with cGMP’s and site procedures.
• Approve suite and equipment changeovers between client processes.
• Review autoclave logbooks and facilitate corrections.
• Conduct Fit and Finish inspections per risk assessments and guiding procedures.
• Perform monthly aseptic observations in Biosafety Cabinets.
• Participate in manufacturing and QA huddles.
• Act as Quality Management Representative as needed.
• Develop personal knowledge and skills.
• Complete all training requirements promptly.
• Provide training and mentorship to new or less experienced team members.
• Qualify new team members for tasks requiring QSME training.
• Write and review deviations using Trackwise.
• Author, revise, and review procedures in eDMS.
• Write and implement CAPAs.
• Conduct and participate in investigation interviews/RAPIDs.
• Utilize tact and diplomacy to resolve issues and maintain quality culture without direct authority.

Essential Skills

• Proven quality assurance and inspection experience.
• Understanding of GMP and FDA pharmaceutical QA practices.
• On-floor QA oversight and process experience.
• Proficiency in CAPAs and SOPs.
• Experience in batch record review and root cause analysis.

Additional Skills & Qualifications

• Bachelor's Degree in Life Sciences or related field with a minimum of three years of relevant experience.
• Cleanroom manufacturing experience preferred.
• Knowledge of quality practices and cGMP regulations.
• Experience with Track Wise and root cause analysis tools.
• Technical writing skills for document management software.
• Tech transfer experience is advantageous.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.

Work Environment

The work environment involves spending 80% of the time in the core area, gowned in either blues or whites, with the remaining 20% at the desk. The position requires adherence to clean room gowning standards, including wearing Tyvek, Nitrile, and Latex gloves. The role follows a rotating 12-hour day shift schedule (6:15am-6:45pm) with a 223 schedule, requiring the ability to lift a minimum of 25 lbs independently and stand for 80% of the shift. The facility is fast-paced and focused on biologic drug substance manufacturing, operating around the clock to support clinical and commercial manufacturing.

Pay and Benefits

The pay range for this position is $33.00 - $36.00/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 Saint Louis,MO.

Application Deadline

This position is anticipated to close on Jul 8, 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 actalentaccommodation@actalentservices.com for other accommodation options.