Microbiologist - Laboratory Testing

The position is responsible for performing microbiological analyses, in process bioburden testing, final product endotoxin and sterility testing.

II. Specific Duties, Activities, and Responsibilities Base Completely, accurately, and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements

Demonstrates high ethical standards

Maintain current training status on relevant equipment and procedures

Comply with all cGMP, regulatory and corporate and EHS requirements

Demonstrates ability to multi-task and prioritize work

Maintain laboratory in audit readiness per cGDP and cGMP practices

Perform peer review for testing and calculations, as necessary

Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary

Laboratory Work Maintain, clean, and sterilize laboratory instruments and equipment

Perform water sampling, including DI water, WFI and steam

Perform sterility, endotoxin, bioburden testing of product and microbiological samples

Subculture and characterize microbial isolates using Gram stain

Perform growth promotion testing of liquid and plated media, including media fills

Perform bacteriostasis/fungistasis testing to validate test methods

Process and incubate exposed biological indicators

Receive and prepare samples and equipment for testing

Incubate and examine tests, including but not limited to bioburden, sterility, BIs and media fill units

Enumerate bacteria; prepare shipments for outside laboratories

Understand the science behind the above listed testing requirements, be able to clearly communicate testing requirements and expectations.

Understand environmental monitoring, the different testing requirements, and the interpretation of the results.

Operate and maintain laboratory equipment, including but not limited to incubators, autoclaves, ovens, vacuum pumps; assist with qualifications and validations

Support R&D and Technical Services activities

Maintain effectiveness of the Quality System components relevant to this position.

Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.

Other duties as assigned.

III. Position Requirements Education or Equivalent B.S in Microbiology, Biological Sciences, or equivalent

Experience Experience in a lab setting (academic, intern or other)

Knowledge/Skills Requirements Demonstrated intermediate mathematical ability

High level of attention to detail, well organized and multi-task oriented

Strong communication skills both written and oral

Strong problem solving and analytical skills

Works well in a team environment with a variety of individuals and personalities within and between departments

Must be able to multitask, be proactive and willing to take initiative and responsibility

Should be familiar with cGMP and safe work practices

Make sound judgments. Act ethically

Demonstrated ability to read, write, and speak clear English.

Physical Requirements Ability to stand for up to 8 hours per day

Visual Acuity (20/30 corrected vision)

May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others

Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, twisting, writing, talking, bending, handling, turning, balancing, carrying, grasping, listening

Occasional walking up inclines and uneven terrain, stooping, kneeling, crouching

Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 30 pounds

#J-18808-Ljbffr