Microbiology Manager - Pharmaceutical Sterile Environment

4 days left

KVK Tech
Langhorne, Pennsylvania, US
Jun 03, 2021
Jun 24, 2021
Employment Type
Full time
Salary Type
Job Description
1. Employee details:

Department: Microbiological Services

Location: 38 Cabot

Job Title: Microbiology Manager

FLSA Status: Exempt

2. Role Purpose:

The basic function of the Microbiology Manager is to conduct quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP Standard Operating Procedures.

3. Key Duties & Responsibilities:
  • Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, and water quality analysis (Bioburden, Endotoxin, TAMC, BET Sterility, Coliforms).
  • Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
  • Coordinates the scheduling of personnel to maximize productivity.
  • Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
  • Coordinates and communicates delays and technical issues with management in a timely manner.
  • Maintains and performs the peer review process in support of client and laboratory quality objectives.
  • Devises and develops processes and methods for the solution of technical problems.
  • Performs system maintenance and calibration to ensure equipment is operating within specified requirements.
  • Trains, mentors and supervises Microbiologists in their group. Coordinates with the microbiology team, execution of protocols, investigations and product development (specific) testing.
  • Reviews lab investigations and deviations with microbiologists in their group. Conducts root cause analysis and implements solutions in collaboration with the chemists.
  • Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
  • Ensures all work performed is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
  • Follows all safety rules and regulations.
  • Follows all cGMP rules and regulations.
  • Documents work in a clear and organized manner.
  • Maintain a clean and orderly laboratory environment.
  • Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.

4. Typical Supervisory Responsibility:

This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.

5. Education/Technical Competencies/ Certifications/ Licenses:

Technical competencies
  • Demonstrated skills in laboratory techniques.
  • Solid computer skills.
  • Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
  • Must be a team player with integrity and concern for the quality of Company products, services and staff members.


ยท Master's and/or Bachelor's degree in Microbiology or related field

6. Physical Demand and Work Environment:

a. Physical demands:

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision and depth perception.

b. Work environment:


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