Tolmar · 21 hours ago
Supervisor Quality Control (Onsite) - 2nd Shift
Fort Collins, CO
Full-time
Onsite
Mid, Senior Level
$100K/yr - $105K/yr
6+ years expTolmar is a company dedicated to supporting the well-being of patients, and they are seeking a Supervisor for Quality Control. The role involves supervising a team of analysts responsible for testing and releasing products, ensuring compliance with processes, and meeting manufacturing timelines.
BiotechnologyHealth CareManufacturing
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
Qualification
Required
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
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
Benefits
Bonus Eligible
Shift Differential
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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