Supervisor Quality Control - Incoming (Onsite)

Purpose and Scope

Provide direct supervision of a team of associates responsible for the testing and release of Tolmar incoming materials in support of manufacturing timelines.

Essential Duties & Responsibilities

• Supervise the testing and release of Tolmar Incoming materials including labels, cartons, syringes, containers, etc.
• Ensure roadblocks are resolved in a timely manner while ensuring GxP compliance.
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results and establish sample priorities for reports.
• Aid in setting procedure and ensure that all operations and functions are in full FDA, cGMP compliance and that staff is properly trained.
• Assist the quality control chemistry investigators with deviations, investigations, projects, or complaints.
• Reports established KPIs for the incoming team.
• Maintains, develops, implements and maintains associated incoming quality systems and procedures related to incoming inspection, sampling and material release.
• Reviews and approves associated process documents in the QMS.
• Reviews and approves COAs for the analysis of components and raw materials.
• Executes change control actions associated with incoming inspection.
• Collaborates with supplier quality on supplier notifications.
• Collaborate with the instrumentation team on associated incoming equipment as instrument issues arise.
• Ensure cleaning and monitoring is scheduled and completed per schedule.
• Identifies, oversees and supports operational excellence projects for the team, including striving towards the implementation of cost saving initiatives.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitors departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Performs designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Conducts interviews, mentor, coach, develop and retain a team of quality professionals including reviewing and approving CBT materials.
• 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.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Cross-trains with other supervisory functions within the QCC laboratory.
• Participates 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 required by business demands.

Knowledge, Skills & Abilities

• Technical leadership when working on complex problems within the scope of the position, in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.
• Ability to supervise a team of professionals that is fully compliant with current Good Manufacturing Practices.
• Prior experience of incoming inspection processes and procedures.
• Effective oral and written communication.
• Ability to prepare, review, conduct and assess associated quality defects.
• Ability to coordinate activities to assure department and company needs are met in terms of sample analysis cycle time.
• Proficient with 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 incoming materials.

Core Values

• The Quality Control Supervisor is expected to operate within the framework of Tolmar's Core Values:




• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree in a scientific discipline
• Four or more years' experience in a GMP environment
• Supervisory or team lead experience is preferred.

Compensation and Benefits

• Annual pay range $97,000 - $105,000
• Bonus eligible
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Working Conditions

• Various work environments including, office, warehouse, and manufacturing environment.
• 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.
• Business demands may present a need to work extended hours.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.