Supervisor, Microbiology

Fresenius Kabi•Wilson, NC

8d•Onsite

About The Position

This position reports to the Manager, Microbiology and is responsible for effectively hiring, developing, coaching, counseling, managing and motivating staff. The supervisor is responsible for supervising the activities of lab technicians up through Lead Scientist levels. They are responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as USP and EP. The supervisor identifies areas for validation and/or improvement and develops protocols for same. The supervisor keeps the manager informed of all departmental activities and product related events.

Requirements

Supervising the activities of lab technicians up through Lead Scientist levels.
Timely and accurate completion of required testing of Environmental Monitoring (EM)/Utilities, raw materials, in-process and finished products.
Assure compliance to GMP and company specifications as well as USP and EP.
Identify areas for validation and/or improvement and develops protocols for same.
Keep the manager informed of all departmental activities and product related events.
Hiring and training of department personnel.
Maintaining positive personnel morale and development.
Conducting performance evaluations.
Execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
Establishing goals for the timely release of product and performance of projects.
Monitoring performance of the group against the goals to identify and implement needed corrective action.
Generating new/revise Standard Operating Procedures for Microbiology test procedures.
Investigating raw material, component, product, or monitoring results that do not meet specifications or expectations.
Identifying possible source and corrective action needed and evaluating the impact upon the product.
Identifying significant adverse quality trends by preparing and analyzing summary reports.
Addressing quality control test results, microbial profiles of environmental/utilities systems, and customer complaints.
Reviewing work performed by department staff for accuracy, completeness and conformance to specifications.
Overseeing training of departmental personnel in appropriate technique and related topics.
Mentoring and developing new department personnel including training in Standard Operating Procedures and training checklists.
Ensuring department is equipped with functional, calibrated equipment and necessary supplies.
Supervising investigations of non-conforming raw material, product or components and determining disposition.
Working closely with Production, Quality Assurance, Chemistry, Maintenance, Metrology and Validation departments to ensure area environmental monitoring, product testing, PM, calibration and re-qualification schedules are met.
Supervising qualification/requalification program for production and laboratory personnel.
Investigating and resolving non-conforming test results by completing thorough Deviation, OOS/OOT, EE and Investigation.
Ensuring adequate evaluation of new product processes.
Supervising validation activities for responsible area.
Acting as a Manager in the absence of the manager.
Representing the department in cross functional teams and meetings.
Assuming other duties and responsibilities as assigned.

Responsibilities

Supervises daily activities of scientists and technicians.
Assures that job activity deadlines are met on a timely basis.
Hires and oversees the training of department personnel.
Assures that steps are taken to maintain positive personnel morale and development.
Conducts performance evaluations.
Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
Establishes goals for the timely release of product and performance of projects.
Monitors performance of the group against the goals to identify and implement needed corrective action.
Generates new/revise Standard Operating Procedures for Microbiology test procedures.
Ensures that raw material, component, product, or monitoring results that do not meet specifications or expectations are promptly investigated.
Identifies possible source and corrective action needed and evaluates the impact upon the product.
Identifies significant adverse quality trends by preparing and analyzing summary reports.
Addresses quality control test results, microbial profiles of environmental/utilities systems, and customer complaints.
Reviews work performed by department staff for accuracy, completeness and conformance to specifications.
Oversees training of departmental personnel in appropriate technique and related topics.
Mentors and develops new department personnel including training in Standard Operating Procedures and training checklists.
Assures department is equipped with functional, calibrated equipment and necessary supplies.
Supervises investigations of non-conforming raw material, product or components and determines disposition.
Works closely with Production, Quality Assurance, Chemistry, Maintenance, Metrology and Validation departments to ensure area environmental monitoring, product testing, PM, calibration and re-qualification schedules are met.
Supervises qualification/requalification program for production and laboratory personnel.
Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, EE and Investigation.
Ensures adequate evaluation of new product processes.
Supervises validation activities for responsible area.
May act as a Manager in the absence of the manager.
Represents the department in cross functional teams and meetings.
Assumes other duties and responsibilities as assigned