Job Title: Quality Engineer IIJob Description

The In-Process Quality Engineer performs a variety of quality-related functions with the intent of providing Quality guidance and oversight of the manufacturing operations at the St. Louis Plant. The scope of the position includes responsibility in OOS investigations, CAPAs, Exceptions, Change Controls, with a focus on Customer Complaints. This role serves as a technical leader in the Quality function by partnering with Manufacturing, Supply Chain, and other Quality groups.

Responsibilities

• Manage and maintain Customer Complaints for the site.

• Write, review, and approve Exceptions, OOSs, CAPAs, Customer Complaints, and Change Controls in a computerized system.

• Provide direct support for regulatory and customer inquiries/issues.

• Ensure appropriate responses to internal, corporate, customer, and regulatory audits/inspections.

• Generate written correspondence and reports based on internal or customer requests in a timely manner.

• Lead and participate in Root Cause Analysis and Process Improvement Teams.

• Regularly use communication skills to exchange technical information with other departments.

• Develop systems for ensuring cGMP compliance of manufacturing documentation systems, quality of documentation, and remediation of issues.

• Report and present trends to management groups during scheduled review periods.

• Follow all internal and basic cGMP guidelines for pharmaceutical operations.

• Perform GMP walkthroughs with production on a routine basis.

• Adhere to all safety rules and maintain 100% completion of all safety-required training.

Essential Skills

• Minimum of 3 - 5 years of experience in Quality Assurance/Quality Control in a pharmaceutical manufacturing environment.

• 2+ years of experience managing investigations, OOS, CAPAs, and Change Controls.

• Bachelor of Science degree in Chemistry, Chemical Engineering, or related science.

• Demonstrated expertise in root cause analysis tools.

• Excellent oral/written communication and leadership skills.

• Understanding of basic statistical principles and regulatory expectations.

• Proficient in Metric Stream, BPCS, and TrackWise applications.

• Knowledge of GMPs for APIs including ICH Q7, CFR 210 and 211.

• Knowledge of Quality Systems.

Additional Skills & Qualifications

• Bias toward change, management of change, and achievement of results.

• Ability to quickly identify, communicate, and/or resolve issues.

• Ability to build relationships with partners.

• Advanced Microsoft Office and computer skills.

Work Environment

The position involves 10% laboratory exposure to plant products, solvents, and reagents, some of which are hazardous or potent compounds. Another 10% involves exposure to the manufacturing environment, including temperature, noise, and chemical or potent compound exposure. The remaining 80% of the time is spent in an office environment, which requires sitting for long periods and computer use. Daily interactions with Manufacturing personnel, Quality Engineers, Quality Control Labs, and Quality Management members are expected to provide guidance and resolve issues. The standard work schedule is Monday-Friday from 8:00 am to 5:00 pm, with occasional overtime as needed.

Pay and Benefits

The pay range for this position is $75000.00 - $80000.00/yr.

• Medical• Dental• Vision• 401K (3% core contribution and 50% match up to 1st 8% employees contribute)• Tuition Reimbursement• PTO – 20 days (use it or lose it – accrued throughout the year, but front-loaded to be used at any time). Amount increase as tenure increases – I.e.: 5 additional days after 5 years.• 8 designated holidays• 4 floating holidays (to be scheduled like PTO)

Workplace Type

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

Application Deadline

This position is anticipated to close on Mar 14, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.