Microbiologist

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 52,000 - 68,000; Full time

Job summary

Woodstock Sterile Solutions is seeking a microbiology analyst responsible for performing microbiological analyses, in-process bioburden testing, endotoxin and sterility testing of final products in a cGMP environment. You will maintain equipment, prepare laboratory reports, interpret data, and collaborate with QA and R&D to support release testing, qualification activities, and continuous improvement.

A Bachelor’s degree in Microbiology or Biological Sciences and prior lab experience are

Qualifications

• Bachelor's degree in Microbiology or Biological Sciences required.
• Experience in a lab setting (academic, internship, or equivalent).
• Familiarity with cGMP and good documentation practices (GDP).

Responsibilities

• Completely, accurately, and precisely prepares all laboratory reports and test scripts per cGDP/cGMP requirements.
• Maintain, clean, and sterilize laboratory instruments and equipment.
• Perform sterility, endotoxin, bioburden testing of product and microbiological samples.
• Subculture and characterize microbial isolates using Gram stain.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality and communicate risk policies.

Skills

Microbiology

Attention to detail

Data analysis

Communication

Teamwork

SOP compliance

English literacy

Education

B.S in Microbiology, Biological Sciences, or equivalent

Job description

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