Kelly Services Quality Control Supervisor in Windsor, Colorado
Quality Control Supervisor
2nd Shift 2-11 PM
Accountable for laboratory compliance with company procedures, regulatory submissions, cGMPs and applicable cGLPs as well as supervising the analysts that perform the testing and release of company products, cleaning samples, raw materials, and stability samples.\t
Provide assistance, training and leadership for direct reports in addition to ensuring the timely delivery of administrative tasks such as time entry and approval, resource allocation and workload balancing.\t
Responsible for ensuring GDP is followed in the QC laboratory.\t
Assist analysts in troubleshooting of instrumentation.\t
Remain up to date with advancements in laboratory analysis and operations.\t
Evaluate and coordinate method transfers to the QC laboratories. Works with department management and R&D management to mitigate any method transfer issues.\t
Perform lab investigations and root cause analysis. Identifies and completes CAPA.\t
Provide technical expertise for document (protocols, reports, and procedures) authoring and review within the QC department. Upon delegation may have the final authority for review and approval of such documents.\t
Serve as a technical resource for products and testing under their direct supervision.\t
Coordinate activities to assure customer needs are met in terms of sample analysis cycle time.\t
Mentor others in the department to ensure department maintains high standards for quality of work.\t
Work with department leadership to ensure procedures are implemented that maintain department quality standards.\t
Responsible for ensuring that company and regulatory data integrity guidelines are met.\t
Participate in required monthly safety trainings and annual HAZ-COM, RCRA and API handling trainings. Hazardous waste involvement may include but is not limited to making waste determinations, generation, transportation, satellite accumulation, storage and disposal of multiple types of waste streams, and container management and inspections. Respond to spills per company procedure. Maintain compliance to all company health and safety policies, as well as OSHA standards. \t
Responsible for communicating the department culture regarding teamwork. Actively supports team building activities through team meetings, off-site activities, etc. Actively works to identify teamwork breakdowns and works to resolve team issues with the guidance of upper QC management. Exhibits a positive attitude at all times. \t
Support adherence to department budget by identifying alternative cost-saving and compliant materials and equipment, where appropriate.\t
Participate on project teams, company and department meetings, third party audits, and regulatory audits.\t
Assist upper level management in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills and regulatory expertise. \t
Interact respectfully with all other employees both inside and outside of the department and members of management, and shows interest in others' input and reasoning. Appropriately resolves differences of opinion.\t
Responsible for representing the QC chemistry laboratory when communicating with outside departments and vendors.\t
With assistance from QC Manager and Director, coach and mentor staff in order to develop skills and competencies required to meet business needs.\t
Prioritize projects under ones direct supervision to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results and establish sample priorities for reports. Ability to deploy resources in the QC area.\t
Demonstrate leadership aptitude in technical functions and people management. Achieve results through people by successful objective-setting, performance review, motivation, delegation, teambuilding, empowerment and leading by example.\t
Monitor departmental spending to stay within the established budget. Notifies laboratory management of possible budget violations.\t
Make scientific recommendations to management and other departments regarding Quality Control laboratory protocol.\t
Utilize senior leadership to assist in laboratory investigations, projects, or advanced technical issues.\t
Assist the department management with the determination, evaluation, implementation of new systems, and continuous improvement efforts.\t
Perform additional duties as assigned.
Knowledge, Skills & Abilities
Expert knowledge and application of government regulations for drugs or medical devices including GMP, GLP and ICH and their application to laboratory processes.\t
Ability to clearly communicate (verbal & written) and work well with employees at all levels.\t
Mastery in the use of USP, NF and other compendia.\t
Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.\t
Proficient knowledge in analytical testing of drug substances and formulations.\t
Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.\t
Technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.\t
Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.\t
Knowledge of analytical troubleshooting and product investigation.\t
Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers.\t
Ability to prepare, review, conduct and assess analytical method validations.\t
Ability to coordinate activities to assure customer needs are met in terms of sample analysis cycle time.\t
Education & Experience
BS, MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
Pharmaceutical cGMP laboratory work experience combined with BS: 5 or more years; Masters: 3 or more years or PhD: 2 or more years.\t
Experience in the pharmaceutical industry to include experience with cGMP analytical testing, preferably in high-volume Quality Control laboratory.\t
Supervisory or team lead experience is preferred.
Office and Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.\t
Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.\t
Business demands may present a need to work extended hours.
Bachelors or better in Chemistry or related field.
5 years: Experience in Pharmaceutical cGMP Laboratory
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With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm