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
Pay: $55,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Work Location: In person
