25 days old

Quality Assurance Manager

Kelly Services
Fort Collins, CO 80523
**Quality Assurance Manager**

Direct Hire

125K per year plus benefits


Provide management oversight and leadership to the Quality Control laboratory staff.

**Essential Duties Responsibilities:**

Accountable for the supervision and management of QC functions through supervisors, specialty analysts, lead analysts and employees. Manage the testing and release of pharmaceutical products, raw materials, and stability samples on a timely basis. Assist departmental director in executing laboratory planning and process efficiency efforts.

Responsible for talent development and retention of junior staff. Responsible for technical development and empowering of first line supervisors and holding them accountable for activities required to meet deadlines. Represent QC department in management and team meetings. Act as QC contact person for outside stake holders. Manage overall testing and release functions of QC laboratory. Provide assistance, training and leadership for direct reports. Review and approve time cards, vacation requests and resource utilization. Attend production planning meetings.

Provide evaluation of the overall validity of the analytical results reported. Establish sample priorities for reports. Review and approve technical reports, test methods and procedural documents. Generate certificate of analysis and review stability reports. Review and approve investigations, CAPA and effectiveness checks. Accountable for cGMP compliance of laboratory. Accountable for maintaining a safe working environment in the laboratory. Participate on project teams, third party audits, and regulatory audits. Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.

Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.

Perform other duties as business demands. Knowledge, Skills Abilities Proficient knowledge in analytical testing of drug substances and formulations.

Proficient knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage. Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work. Excellent supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs.

Proficient building and maintaining effective relationships and strong interpersonal / communication skills. Ability to coordinate activities to assure customer needs are met in terms of sample analysis cycle Ability to deploy resources in the QC area.

**Education Experience**

Bachelor s degree in scientific discipline, preferably in chemistry or biochemistry. Ten or more years in an analytical laboratory environment, at least 8 of which are in a pharmaceutical GMP setting. Minimum of 5 years of experience in a supervisory position in a laboratory


**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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-09 Expires: 2022-10-10

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Quality Assurance Manager

Kelly Services
Fort Collins, CO 80523

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