Microbiologist I
Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work Sunday - Thursday, 8 am - 5 pm.
I. Position Overview:
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
Excellent documentation skills
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
Job Type: Full-time
Pay: $52,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Referral program
Vision insurance
Schedule:
8 hour shift
Ability to commute/relocate:
Woodstock, IL 60098: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person