Core Hours: Monday - Friday, 8:00 am - 5:00 pm
Purpose and Scope
Provide direct supervision of a team of analysts responsible for the testing and release of Tolmar products in support of manufacturing timelines.
Essential Duties & Responsibilities
- Prioritize workload to meet timelines while ensuring on-time delivery of all projects, testing and action items.
- Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
- Escalate and communicate items which arise per the timelines specified in the department escalation strategy.
- Execute all business and department goals and initiatives on time.
- Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
- Issue all Certificates of Analysis within 2 business days of last test completion.
- Generate, monitor and report weekly team and analyst KPIs.
- Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
- Strive to balance workload across all sites and teams to ensure adequate resource allocation.
- Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
- Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
- Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
- Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
- Create and revise developmental plans to help employees grow their skills and advance their careers.
- Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
- Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
- Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
- Support and execute all potential 3-day field alert investigations and actions expeditiously.
- Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
- Ensure all samples logged into the LIMS system are submitted correctly.
- Identify, and complete cost savings initiatives and facilitate continuous improvement.
- Participate in leadership development activities and take an active role during department and company activities.
- Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
- Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
- Conduct and coordinate laboratory investigations, and all associated actions.
- Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
- Participate in project teams, company and department meetings, third party audits, and regulatory audits.
- Monitor departmental spending to stay within the established budget.
- Demonstrate leadership aptitude in technical functions and people management.
- Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
- Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
- Accountable for meeting departmental and compliance timelines.
- 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.
- Participate in the interview and selection process for candidates, as required.
- Perform other duties as required by business demands.
Knowledge, Skills & Abilities
- Possesses a strong sense of purpose and drive to meet deadlines without sacrificing quality.
- Balances the need for speed with a commitment to accuracy and quality, completing tasks thoughtfully and effectively
- Expert knowledge in analytical testing of drug substances and formulations for Chemistry or Microbiology.
- Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
- Proficient with computer systems for sample tracking, laboratory equipment, raw data handling and storage.
- Knowledge in analytical method validation and instrument qualification.
- Thorough knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
- 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.
- Exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the QC department.
- Ability to supervise a team of analytical professionals that is fully compliant with current Good Manufacturing Practices.
- Knowledge of analytical troubleshooting and product investigation.
- Effective oral and written communication.
- Proficient in the use of analytical laboratory instruments such as HPLC, FTIR, GPC, GC, and UV-Vis spectrophotometers, CCIT, Endotoxin, MODA,.
- Ability to prepare, review, conduct and assess analytical method validations, feasibility and suitable for use.
- Ability to coordinate activities to assure customers’ needs are met in terms of sample analysis cycle time.
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 and treat 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 with an enterprise‑wide mindset that lifts the whole organization.
- 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- 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 science, preferably in Chemistry or Biochemistry, or Microbiology.
- Six or more years’ experience in an analytical laboratory environment with at least five years in a pharmaceutical GMP setting. Supervisory or team lead experience is preferred.
Working Conditions
- Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
- Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality to meet important timelines in a high throughput lab.
- Business demands present a need to work extended hours.
- On call weekend support will be required with a minimum of 8 on call weekends each year.
Compensation and Benefits
- Annual pay range $100,000 - $105,000 depending on experience
- Bonus Eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits (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.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
