Senior Technician - Microbiology - Quality Control

Senior Technician - Microbiology - Quality Control

Title:Sr. Microbiology Technician

Reports to:Micro Lab Manager

Department:Quality Assurance

Supervises:Microbiology Lab Technicians, Jr. Microbiologists

Organizational Relationships: Direct communication with all levels of production and quality assurance.

Basic Function:Implementation and/or coordination of microbiological procedures, policies, and operating objectives in accordance with company policy.

Responsibilities, under the Supervision of the Micro Lab Manager:

1.Implements and assures performance of company microbiological programs and objectives. Also interprets customer micro testing requirements for implementation. Develops processes for reduced testing and cost reductions.

2.Supervises all assigned microbiology personnel.

3.Conducts microbiology training programs.

4.Conducts plant inspections including the taking of samples for environmental testing. Supervises and/or conducts required testing procedures of same and suggests any applicable corrective action

5.In conjunction with the Microbiology Manager and the Technical Objectives, evaluates microbiological personnel programs, goals, objectives, and budgets.

6.Reviews and updates microbiological test procedures and specifications.

7.Participates in special project evaluations.

8.Issues daily micro reports, weekly summaries, develops supplier histories, statistically monitors test results.

9.Participates in development and execution of microbiological research programs consistent with company objectives and programs.

10.
Direct contact with customers and suppliers in regard to quality problems in the microbiological areas.

11.
May attend trade association meetings and functions as kdc/one microbiology representative.

12.
Responsible for microbiological challenge studies of kdc/one formulations and customer formulations.

13.
Initiates OOS & Failure Investigations

14.
Participates in Microbial Limit Testing duties, particularly overflow and technician absence. Review and evaluate results as carried out and recorded by technicians.

15.
Participates in Organism Identification duties.

16.
Carries out any additional assignments as directed by the Micro Lab Manager.

Qualifications:

1.BS Degree – microbiology or equivalent experience

2.Five+ years industry experience

3.Experience in GMP facility

4.Good failure investigative and reporting skills.

5.Ability to develop and write procedures.

6.Computer skills: Microsoft Office Suite (Word, Excel, etc.)

7.Ability to interpret customer testing requirements and implement programs for compliance

8.Ability to facilitate customer and regulatory audits as pertain to micro testing program.