Quality Engineer II

Quality Engineer II (Contract)

The Quality Engineer II is a skilled quality assurance professional with extensive experience in quality or manufacturing within a highly regulated industry. This role focuses on evaluating and improving production processes and performance in manufacturing, with a strong emphasis on contamination and cross-contamination understanding, aseptic practices, and compliance inspections. This position plays a critical role in supporting manufacturing by providing quality input, initiating deviations, and ensuring the production and release of quality bulk drug substances for clinical and commercial clients.

• Oversee activities and provide QA-related input.
• Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality.
• Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations.
• Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination.
• Participate in client and regulatory audits as a Subject Matter Expert (SME) on Fit and Finish, Changeover, and Change Control procedures.
• Observe critical process steps to ensure adherence to guiding procedures, batch records, and established aseptic practices.
• Perform daily GEMBAs of manufacturing areas and provide immediate feedback to ensure compliance with cGMPs, site procedures, and regulatory requirements.
• Perform QA approval of suite and equipment changeover between client processes.
• Conduct autoclave logbook review and facilitate corrections.
• Perform Fit and Finish inspections per risk assessment and guiding procedures.
• Perform monthly aseptic observations of critical activities in Biosafety Cabinets.
• Attend and actively participate in Manufacturing and QA OTF Tier 1 huddles.
• Act as Quality Management Representative as needed.
• Develop personal knowledge and skills in quality standards.
• Provide training, coaching, and mentorship to new and less experienced team members on quality standards.
• Qualify new team members for tasks requiring QSME training.
• Write and review deviations in Trackwise.
• Author, revise, and review procedures in eDMS.
• Write and implement CAPAs as needed.
• Conduct and participate in investigation interviews/RAPIDs.

• Quality assurance expertise.
• Inspection and auditing skills.
• GMP and FDA pharmaceutical QA experience.
• On-floor QA oversight over processes.
• CAPA management.
• SOP and batch record experience.
• Root cause analysis.

• Bachelor's Degree in Life Sciences (biology, chemistry, biochemistry) or a related field with a minimum of three years of relevant experience.
• Cleanroom manufacturing experience preferred.
• Non-science degrees considered with a minimum of seven years of directly related experience.
• Understanding of quality practices and cGMP regulations.
• Experience with investigational writing software (Trackwise) and root cause analysis tools.
• Technical writing skills and proficiency with document management software.
• Tech transfer experience is a plus.
• Experience with Lean Manufacturing and Six Sigma methodologies is a plus.
• Excellent problem-solving and analytical skills.

The work involves spending 80% of the time in a cleanroom environment, requiring full gowning (bodysuit, gloves, hair & beard nets, face covers, safety glasses) and meeting cleanroom gowning requirements. The remaining 20% involves desk work. The role operates on a 2nd shift from 2 PM to 12:30 AM, with rotating 10-hour shifts. Employees must be able to lift a minimum of 25 lbs independently and stand for 80% of the shift.

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

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,…