Sr Supervisor Reagent Manufacturing

The Sr Supervisor Reagent Manufacturing is responsible for the day-to-day supervision of Reagent Manufacturing departments and leading Quality Control (QC) procedures in the non-technical clinical section of the laboratory under the general direction of the Manager of Operations Support and Laboratory Director. The Sr Supervisor Reagent Manufacturing is accountable for supervising non-technical personnel, making sure reagent manufacturing and quality control procedures are performed as documented by trained personnel to ensure accurate reporting and identifying and implementing process improvements.

Ensures that all materials pass QC validation prior to being used in production, ensuring paperwork is completed correctly and on time, ensuring processes are performed according to approved Standard Operating Procedures, and ensuring that sufficient QC'd reagents are available for patient testing.

1. Ensure laboratory compliance with technical, operational, administrative, and safety policies.
2. Plan and supervise daily operations of the QC team to make sure procedures are performed accurately and efficiently.
3. Ensure all raw materials used in the lab are properly prepared, QC'd, and stored prior to use in patient testing.
4. Ensure that Master Mixes are prepared, dispensed, and evaluated according to current SOP.
5. Ensure that plates are prepared and evaluated and stored in enough quantities to keep the lab in operation.
6. Ensure all documentation and electronic records related to QC activities are accurate and complete.
7. Identify and follow cost saving measures.
8. Prepare the manufacturing plan and ensure it is executed correctly.
9. Ensure the capacity of manufacturing is enough to comply with the volume growth of product/s supported.
10. Ensure that stability studies for Master Mixes are performed and filed as needed.
11. Work with the Supply chain Team to monitor inventory levels of manufactured reagents and ensure adequate supply for Lab use.
12. Ensure proficiency samples are processed in the lab.
13. Track inventory of raw materials needed for manufacturing and work with Supply chain personnel to place orders as needed.
14. Approve release of raw materials and sub-assemblies for use in finished goods.
15. Work with Lab Development, Automations, and R&D to troubleshoot and improve production Lab processes.
16. Work with Lab Development to validate new test methods and develop the QC/manufacturing process for those new test methods.
17. Ensure patient samples are discarded at proper interval/per special request.
18. Oversees troubleshooting efforts with the QC and reagent manufacturing laboratory.
19. Directly interact with vendors regarding quality concerns of reagents.
20. Define user requirements and lead UAT for QC related functions in LIMS and EDM reports.
21. Perform and participate in non-conformance investigations as needed.
22. Development and implementation of departmental technical procedures in accordance with the laboratory's policies and procedures.
23. Ensuring participation of all department personnel in the laboratory's quality assurance plan, adhering to quality control and preventive maintenance policies, and appropriately documenting these activities.
24. Monitoring testing systems to ensure that acceptable levels of performance are maintained and ensuring appropriate corrective action is taken whenever the test system deviates from the laboratory's established performance specifications.
25. Troubleshooting and identifying problems that may adversely affect test performance and/or reporting of test results by initiating corrective action and using the defined electronic system to make the required management notification.
26. Working with the Training Coordinator to ensure the development of an effective departmental training program in accordance with laboratory policy.
27. Evaluating employee performance to ensure acceptable levels of competency and performance are maintained and documented and for taking appropriate promotion or corrective actions related to staff performance.
28. Actively participating in successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs.
29. Identifies areas for improvement and initiates projects.
30. Leads department and cross functional teams to resolve problems or implement projects or participates in such efforts.
31. Participates in or leads department and cross functional teams to resolve problems or implement projects.
32. Serve as a trainer on processes both within and between groups.
33. Ensuring that all staff members participate in continuing education according to accepted laboratory standards.
34. Planning, including staffing, scheduling, and ordering of materials, to ensure the department's ability to meet the companywide production goals.
35. Hiring, development, and retention of qualified staff members.
36. Annually evaluating and documenting the performance of all testing personnel.

1. Bachelor's degree in a chemical, physical, biological, or clinical laboratory/medical technology science.
2. 6 years of pertinent lab experience.
3. At least 3 years of experience as supervisor/manager in equivalent setting.
4. Deep understanding of the respective Laboratory's workflows.
5. Ability to work on-site.
6. Must demonstrate ability to perform tasks correctly and consistently.
7. Follow all rules and regulations and adhere to the highest ethical standards.
8. Excellent time management, scheduling, and organizational skills.
9. Ability to manage multiple tasks in a fast-paced environment.
10. Ability to work effectively under tight timelines and schedules.
11. Ability to work independently and as a contributing team member.
12. Ability to sense the importance or impact of issues and situations and take appropriate actions.
13. Must be flexible, innovative, and self-motivated.
14. Must have the flexibility to work extra hours to meet corporate and departmental goals.
15. Strong communication, interpersonal, organizational, and leadership skills.

Physical Requirements

Lifting Requirements - light work or exerting up to 20 pounds of force frequently. Physical Requirements - stationary positioning, moving, operating, ascending/descending, communicating, and observing. Use of equipment and tools necessary to perform essential job functions.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.