A
QA Engineer (Pharmaceuticals)
Accepting applicationsActalent · St Louis, MO
Full-Time Mid AISicaiarmate
Posted
2d ago
Category
Test
Experience
Mid
Country
United States
Job Title: Quality Engineer II
Job Description
The Quality Engineer II is a quality assurance professional with significant experience in a quality or manufacturing organization within a highly regulated industry. The role involves evaluating production processes and performance in manufacturing, participating in projects to improve quality and efficiency, and supporting manufacturing by providing quality input. The position is crucial in producing and releasing quality bulk drug substances for clinical and commercial clients.
#ACTjobsTFS2026
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 compliance with industry standards and regulations.
Observe aseptic practices and provide immediate coaching to prevent contamination.
Participate in client and regulatory audits as a subject matter expert.
Observe critical process steps to ensure adherence to procedures and aseptic practices.
Conduct daily GEMBAs and provide feedback to ensure compliance with cGMPs and regulatory requirements.
Approve suite and equipment changeovers.
Review autoclave logbooks and facilitate corrections.
Perform Fit and Finish inspections per risk assessment and procedures.
Conduct monthly aseptic observations in Biosafety Cabinets.
Attend and participate in QA OTF Tier 1 huddles.
Act as Quality Management Representative as needed.
Develop personal knowledge and skills.
Provide training and mentorship to new 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 as needed.
Participate in investigation interviews.
Utilize tact and diplomacy to resolve issues and maintain quality culture.
Essential Skills
Experience in quality assurance, inspection, GMP, and audit.
GMP/FDA pharmaceutical QA experience.
On-floor QA oversight experience.
Experience with CAPAs and SOPs/batch records.
Root cause analysis skills.
Ability to perform batch record review.
Proficiency in using Smartsheet.
Additional Skills & Qualifications
Bachelor's Degree in Life Sciences or related field with at least three years of relevant experience.
Cleanroom manufacturing experience preferred.
Understanding of quality practices and cGMP regulations.
Experience with Trackwise and root cause analysis tools.
Technical writing skills.
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 role involves spending 80% of the time on the floor, requiring full ISO 5 and ISO 7 gowning, and 20% of the time at a desk. The position follows a rotating 12-hour shift schedule. The work environment requires adherence to cleanroom gowning requirements, lifting a minimum of 25 lbs independently, and standing for 80% of the shift. The facility is a fast-paced biologic drug substance manufacturing site, focused on cell process development and supporting clinical and commercial manufacturing. The products produced here treat chronic health conditions, including cancers and other life-threatening diseases.
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 - $36.00/hr.
Requirements
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 May 25, 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 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 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.
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Job Description
The Quality Engineer II is a quality assurance professional with significant experience in a quality or manufacturing organization within a highly regulated industry. The role involves evaluating production processes and performance in manufacturing, participating in projects to improve quality and efficiency, and supporting manufacturing by providing quality input. The position is crucial in producing and releasing quality bulk drug substances for clinical and commercial clients.
#ACTjobsTFS2026
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 compliance with industry standards and regulations.
Observe aseptic practices and provide immediate coaching to prevent contamination.
Participate in client and regulatory audits as a subject matter expert.
Observe critical process steps to ensure adherence to procedures and aseptic practices.
Conduct daily GEMBAs and provide feedback to ensure compliance with cGMPs and regulatory requirements.
Approve suite and equipment changeovers.
Review autoclave logbooks and facilitate corrections.
Perform Fit and Finish inspections per risk assessment and procedures.
Conduct monthly aseptic observations in Biosafety Cabinets.
Attend and participate in QA OTF Tier 1 huddles.
Act as Quality Management Representative as needed.
Develop personal knowledge and skills.
Provide training and mentorship to new 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 as needed.
Participate in investigation interviews.
Utilize tact and diplomacy to resolve issues and maintain quality culture.
Essential Skills
Experience in quality assurance, inspection, GMP, and audit.
GMP/FDA pharmaceutical QA experience.
On-floor QA oversight experience.
Experience with CAPAs and SOPs/batch records.
Root cause analysis skills.
Ability to perform batch record review.
Proficiency in using Smartsheet.
Additional Skills & Qualifications
Bachelor's Degree in Life Sciences or related field with at least three years of relevant experience.
Cleanroom manufacturing experience preferred.
Understanding of quality practices and cGMP regulations.
Experience with Trackwise and root cause analysis tools.
Technical writing skills.
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 role involves spending 80% of the time on the floor, requiring full ISO 5 and ISO 7 gowning, and 20% of the time at a desk. The position follows a rotating 12-hour shift schedule. The work environment requires adherence to cleanroom gowning requirements, lifting a minimum of 25 lbs independently, and standing for 80% of the shift. The facility is a fast-paced biologic drug substance manufacturing site, focused on cell process development and supporting clinical and commercial manufacturing. The products produced here treat chronic health conditions, including cancers and other life-threatening diseases.
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 - $36.00/hr.
Requirements
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 May 25, 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 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 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.
Show more Show less