Job Description
Job Description
Summary/Objective
The Microbiology Analyst III is responsible for developing procedures, performing investigations, and performing routine analysis of raw material and finished product according to established specifications and procedures. YOU MUST BE ABLE TO WORK ON-SITE IN MOUNT LAUREL, NJ.
Salary Starting at $30 hourly depending on experience plus 2 bonuses per year.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Perform method development and validation for sterility, bioburden, endotoxin, particle size distribution of products including, but not limited to, injections, ophthalmic preparations, oral tablets, oral liquids, raw materials, and components
- Perform method development and validation for rapid sterility and bioburden test methods, specifically using ATP bioluminescence detection
- Perform method development and validation for Antimicrobial Effectiveness Testing (AET) for sterile and non-sterile finished product
- Perform and/or assist in investigations
- Perform/review/approve, lead and schedule routine analysis of finished product, raw material, and components according to established specifications and procedures relating to:
- Sterility
- Bioburden
- Endotoxin
- AET
- Particulate Matter
- Container Closure
- Particle Size Distribution
- Water Activity
- Perform atypical particulate inspection and prepare report
- Performs/reviews/approves media qualification (Sterility and promotion) and perform QC release
- Support microbiological testing on facility water (WFI, CS, etc.) and biological indicators
- Review and approve data related to testing
- Support writing, review, and approval of protocol, standard operating procedure, work instructions, and reports for client
- Support developing new projects and methods
- 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
- Interprets and applies specifications and operating procedures when carrying out and reviewing testing responsibilities
- Prepare, review, and approve inhouse media, reagents, and test samples as required
- Prepare microorganisms for identification, perform/review Gram staining. Perform and interpret microbial identification results
- Performs/reviews sample receipt, manages and disposes analyzed samples as needed
- Perform/review and maintain laboratory and equipment cleanliness
- Must be proficient in training new and existing employees
- Understand and demonstrate aseptic technique
- Proficient in membrane filtration in relation to sterility and bioburden testing
- Maintains laboratory supply inventory and re-order as needed
- Perform root cause analysis and determines and implements corrective actions for errors and issues as necessary
- Maintains all equipment properly and co-ordinates servicing of all equipment used in the laboratory as needed
- Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)
- Support audits by regulatory agencies, such as FDA, BOP and DEA
Required Education and Experience
- B.S. degree in Microbiology, Biology or related scientific field
- Minimum 5 years of experience in a microbiology laboratory or pharmaceutical industry
- Knowledge and understanding of USP <71>, USP <61>, USP <62>, USP <1111>, USP <51>, USP <788>, USP <789>, USP <85>, and USP <429>
- 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 customer service and verbal communication skills
- 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
- Experience with LIMS preferred
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.