Microbiology Manager

Company: HCPro, Inc.
Location: Salem
Posted on: September 13, 2020

Job Description:

Boston Analytical is a premier  cGMP  compliant laboratory, FDA and DEA registered for pharmaceutical analytical testing. We provide the highest quality analytical testing services to Pharmaceutical, Biopharmaceutical, and Medical device companies worldwide. Since 1987, Boston Analytical has been and remains dedicated to customer satisfaction and to the fast and accurate analysis of our clients' products.

The basic function of the Microbiology Manager is to conduct quantitative and qualitative analysis of

pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard

Operating Procedures. In addition, the Group Leader mentors, trains and supervises the

Microbiologists in their group. The essential duties and responsibilities of this position include

the following. Other duties may be assigned as needed.

PRIMARY DUTIES AND RESPONSIBILITIES

Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).

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.

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.

REQUIREMENTS & QUALIFICATIONS

Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline required with 2+ years of experience with Boston Analytical and/or 5+ years of related experience. Knowledge of cGMPs and related compliance regulations and guidances required. SHIFTS: 1st & 2nd  shift available.

Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS , and ELN .

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.

This is a 2nd Shift position working Monday through Friday from 2:00 pm - 10:30 pm.

MINIMUM SKILLS REQUIREMENT

Demonstrated skills in laboratory techniques.

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.

Boston Analytical is a growing pharmaceutical contract lab providing quality Analytical and Microbiological testing services. We are known for our quality and believe our success is driven by our employees. We provide our employees with a state-of-the-art work environment, excellent benefits and opportunities for development.

Requirements

REQUIREMENTS & QUALIFICATIONS

Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline required with 2+ years of experience with Boston Analytical and/or 5+ years of related experience. Knowledge of cGMPs and related compliance regulations and guidances required. SHIFTS: 1st & 2nd  shift available.

Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS , and ELN .

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.

This is a 2nd Shift position working Monday through Friday from 2:00 pm - 10:30 pm.

MINIMUM SKILLS REQUIREMENT

Demonstrated skills in laboratory techniques.

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.

Boston Analytical, the Life Sciences Division of Alpha Analytical, is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 Certified, world class pharmaceutical testing laboratory. Providing a variety of high quality testing services such as Analytical Testing, Microbiological Testing, and Stability Testing/Storage, Boston Analytical is dedicated to customer satisfaction and to providing on-time, accurate analysis. Located in Salem, NH, Boston Analytical’s laboratories employ LabWare Inc.’s™ LIMS and ELN software, prov...

Assistant Property Manager Needed for Property in...

1025 Connecticut Ave NW, Suite 1000 Washington, Dist. Columbia 20036 (866) 313-6311

Keywords: HCPro, Inc., Salem , Microbiology Manager, Other , Salem, Oregon