Quality Engineer II

Description

Quality Engineer II is a quality assurance professional with substantial prior experience of working within a Quality or Manufacturing organization in a highly regulated industry. This individual specializes in evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. Other job duties include but are not limited to understanding contamination/cross-contamination, observing aseptic practices, performing daily GEMBAs of manufacturing areas, continuously assessing fit and finish of the facility, and performing compliance inspections within manufacturing areas. This role supports Manufacturing by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients. Will be working on the floor 80% of the time to observe manufacturing doing the process and making sure they are following SOP's and batch records. The other 20% of the time will be at their desk doing quality document review and working through deviations with supervisors. - Oversee activities and provide perspective 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 in preparation for internal quality audits, client audits, and regulatory inspections - Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination - Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices - Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time - GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements - Perform QA approval of suite and equipment changeover between client processes - Perform autoclave logbook review and facilitate corrections - Perform Fit and Finish inspections per the risk assessment and guiding procedures - Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets - Attend and actively participate in MFG huddles - Lead/attend and actively participate in QA OTF Tier 1 huddles - Act as Quality Management Representative for the company as needed - Take actions to develop one’s own knowledge and skills - Perform all training requirements in a timely manner - Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies - Qualify new team members to perform tasks that require QSME training - Write and review deviations in Trackwise as required - Author, revise, and review procedures in eDMS as required - Write and implement CAPA’s as needed - Conduct/participate in investigation interviews/RAPIDs as required - Individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.

Skills

Quality assurance, Inspection, Gmp, Audit, Quality inspection, Root cause analysis, Capa, batch record review, batch record, smartsheet

Top Skills Details

Quality assurance,Inspection,Gmp,Audit,Quality inspection

Additional Skills & Qualifications

Bachelor's Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry) or another science related field combined with a minimum of 3 years of relevant experience is required Cleanroom manufacturing experience is highly preferred, but not required along with a comfort level with full ISO 5 and ISO 7 gowning requirements Non-science degrees will be considered if combined with a minimum of five (5) years of directly related work experience in biopharmaceutical manufacturing - Understanding ‘why’ and not just the ‘how’ of processes and practices - Knowledge of Quality practices and cGMP regulations and other international health authority guidelines - Experience with investigational writing software system (Track Wise) along with root cause analysis tools utilized in deviation investigations - Technical writing skills and the ability to write/revise procedures in 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

Experience Level

Entry Level

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 $32.00 - $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 1, 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 click.appcast.io 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.