Supervisor Microbiology

4 days left

Employer
Cambrex
Location
Whippany, New Jersey, US
Salary
Competitive
Posted
Apr 28, 2021
Closes
May 10, 2021
Ref
2059219582
Discipline
Biology, Energy
Employment Type
Full time
Salary Type
Salary
With over 35 years' experience and a growing team of over 2,000 experts servicing global clients from our sites in North America and Europe, we are tried and trusted in branded and generic markets for API and dosage form development and manufacturing.

We put all of our energy and experience into being your partner of choice
We create value for customers through manufacturing excellence, reliable quality and innovative science
Our people are the experts customers enjoy working with
We truly offer our customers an end-to-end partnership for the research, development and manufacture of small molecule therapeutics at every stage of the lifecycle.

The Supervisor Microbiology oversees and coordinates the daily activities of the Microbiology Laboratory to ensure lab testing provides the highest quality microbiological support for manufacturing while ensuring compliance with protocols, cGMPs and safety regulations. The incumbent performs monitors and evaluates microbiological testing of finished products, chemical components, water and environmental samples. The Supervisor interacts with other functional departments to ensure microbiology services are provided timely, efficiently and in compliance with all Cambrex procedures and cGMP standards.

  • Supervise Microbiologists in overseeing scheduling and assigning workloads.
  • Initiate, document, and perform microbiological analysis on received test samples as per USP, in-house, or customer methods. Evaluates, records, and reports data.
  • Maintain product quality by conducting microbiologic tests in a clean-room environment and in manufacturing and packaging environments as needed.
  • Performs Water and environmental sampling; evaluates records, and reports data.
  • Maintains adequate inventory of media and materials required for testing.
  • Initiates proper documentation upon discovery of deviations and out-of-specification results, completes report write-up for deviations and out-of-specification results.
  • Appropriately prioritize and delegate assignments and projects for self and team members. Keep management informed of status and issues.
  • Identify, conduct and lead opportunities to continuously improve quality, cost and efficiency of processes in accordance with the strategic direction of the department to fulfill company and department goals
  • Performs special projects as assigned including protocol generation, testing, delegation of tasks, compiling and trending of data, and report generation.
  • Assure that the Micro Lab operates in a safe, clean and environmentally sound manner.
  • Participate in internal and external audits.
  • Reviews documentation for compliance to GMP and test methods.
  • Writes and revises SOPs, forms, protocols and other controlled documents.
  • Maintains intra and interdepartmental communication to support company goals.
  • Must be willing to work a flexible schedule to support shift operations. May be required to provide off-shift supervision to department personnel.
  • Other duties as assigned.

  • Demonstrate computer literacy with proficiency in Microsoft office software.
  • Strong organizational skills desired.
  • Strong oral and written communication skills, including effective listening.
  • Flexibility to work outside of business hours, should issues arise.
  • Ability to recognize what needs to be done, taking action, and accomplishing results as the situation demands.
  • Must be able to ascend/descend a latter and work in confined spaces
  • Required to wear personal protective equipment including a respirator
  • Must be able to move about the facility
  • Must be able to remain sedentary for periods of time

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