22 days old

Quality Assurance Specialist

Kelly Services
Rochester, MN 55905
**Quality Assurance Specialist CMC (Chemistry, Manufacturing & Controls) Rochester, MN**

Quality Assurance staff are responsible for oversight of quality and regulatory compliance for product manufacturing activities. Staff work to identify and reduce regulatory and compliance risk by continuous monitoring and evaluating facility policies and practices to ensure compliance is built into the operational systems.


+ Develop and oversee the product manufacturing compliance program.

+ Monitor operations in the production rooms.

+ Provide direct QA support during manufacturing operations.

+ Work with manufacturing staff to ensure compliance with regulatory requirements associated with internal and external assessments and responses to citations.

+ Develop regulatory and compliance training program for the intended audience.

+ Maintain program and keep it up to date.

+ Perform review of product manufacturing documents for clarity and compliance with regulatory requirements.

+ Ensure compliance concerns are prioritized and resources identified.

+ Ensure product manufacturing service risks are escalated to management.

+ Develop CMC expertise related to manufacturing and ensure change management activities are in place to support reporting requirements for regulatory filings.

+ Coordinate CMC reviews and submissions for GMP manufacturing.

+ Maintain CMC files.

+ Leads the investigation of events that appear to be associated with regulatory violations.

+ Works with relevant parties to resolve issue and take appropriate corrective and preventive action.


+ A Bachelors degree in a science related field is required and a minimum of 2 years experience in a manufacturing quality control/quality assurance role.

+ Knowledge and experience in FDA current Good Manufacturing Practices for product manufacturing is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.

+ Exceptional human relations and communication (written, verbal, and listening) skills are required.

+ Should be very detail-oriented and can work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.

+ Strong analytic skills coupled with critical thinking skills are essential in this role.

+ Must have demonstrated capacity to comprehend complex protocols, programs, and situations.

+ Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

**For Immediate Consideration, Apply Today! For more information contact Toni at 714 454 8252 /, or schedule a time to connect @**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (


Posted: 2021-11-08 Expires: 2021-12-20

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Quality Assurance Specialist

Kelly Services
Rochester, MN 55905

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