Quality Engineer II (Contract)

Job Description

Job Description

Quality Engineer II (Contract)

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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, 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)

This is a fully onsite position in Saint Louis,MO.

This position is anticipated to close on Jul 30, 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 View email address on ziprecruiter.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.