Microbiology Analyst II at Epicur – Mount Laurel Township, New Jersey
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About This Position
Summary/Objective
The Microbiology Analyst II is responsible for supporting microbiology procedures, assisting in investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. MUST - be able to work in Mount Laurel, NJ on-site.
Salary Starting at $25.00 hourly based on experience plus 2 bonuses a year.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Assist in method validation for sterility, bioburden, and endotoxin of drug products including, but not limited to, injections, ophthalmic preparations, oral tablets, and oral liquids
- Assist in method development and validation for rapid sterility and bioburden test methods, specifically using ATP bioluminescence detection
- Assist in method development and validation for Antimicrobial Effectiveness Testing (AET) for sterile and non-sterile finished drug product.
- Perform and/or assist in investigations related to sterility assurance and environmental monitoring
- Perform routine analysis of finished product and raw material according to established specifications and procedures relating to:
- Sterility
- Bioburden
- Endotoxin
- AET
- Particulate Matter
- Visual Inspection
- Growth Promotion
- Perform atypical particulate inspection on finished product
- Support sampling and microbiological testing on facility water (WFI, CS, etc.)
- Record and review data related to sterility, bioburden, AET, Particulate Matter, Visual Inspection and endotoxin testing of finished product and/or raw materials
- Assist in the development and testing for stability program
- Must be proficient in training new and existing employees
- Performs technical review of test results for completeness and compliance to cGMP to ensure that documentation, controls and traceability are in place to maintain integrity
- Prepares and reviews preparation of media, reagents, test samples and equipment as required
- Proficient in membrane filtration in relation to sterility and bioburden testing
- Prepare microorganisms for identification. Perform and interpret microbial identification results
- Perform sample transfer, manages and disposes analyzed samples as needed
- Understand and demonstrate aseptic technique
- Maintains laboratory cleanliness and inventory of microbiology supplies
- Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)
- Assist with environmental monitoring and microbiological trend reports as required
Required Education and Experience
- B.S. degree in Microbiology, Biology or related scientific field
- Minimum 2 years of experience in a microbiology laboratory or pharmaceutical industry
- Knowledge of good analytical and laboratory techniques, GxP, USP and FDA requirements
- Knowledge in statistical data analysis and its application to pharmaceutical or compounding processes and quality controls
- Must exhibit good analytical, writing (GDP), interpersonal and organizational skills
- Must be able to meet deadlines
- Must be detail oriented and have multi-tasking capabilities with ability to prioritize
- Must exhibit strong computer skills including but not limited to software packages supporting statistical data analysis, word processing, and project management programs
- Must have the ability to work in a fast-paced environment
- Must exhibit excellent problem resolution skills
- Must be able to work independently and as part of a team
- Must exhibit punctuality and low absenteeism
- Must be able to sit, stand, reach and walk for prolonged periods of time
Eligibility Qualifications
- Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
- Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry and other cosmetics are prohibited from the production areas)
- May be necessary to work extended hours as needed.
- May be require weekend work.
Competencies
- Communication Proficiency
- Time Management
- Organizational Skills
- Problem Solving/Analysis
- Quality
- Results Driven
- Technical Capacity
- Thoroughness
Supervisory Responsibility
This position has no supervisory responsibilities.
Work Environment
This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.
Language Skills
Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.
Mathematical Skills
Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.
Reasoning Ability
Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Able to sit and/or stand 8-10 hours or more per day as needed
- May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
- Finger dexterity to operate office equipment required
- Ability to lift up to twenty (20) pounds on occasion
Position Type and Expected Hours of Work
This is a full-time position. Because of the nature of the business, work schedules may vary at times.
Travel
No travel is expected for this position.
Disclaimer
The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.
AAP/EEO Statement
Stokes Healthcare is an Equal Employment Opportunity and Affirmative Action Employer.
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Job Location
Job Location
This job is located in the Mount Laurel Township, New Jersey, 08054, United States region.