Microbiology Analyst II

Stokes Pharmacy•Mount Laurel Township, NJ

13d•Onsite

About The Position

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. This role requires the ability to work on-site in Mount Laurel, NJ.

Requirements

B.S. degree in Microbiology, Biology or related scientific field
Minimum 3 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
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)
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.
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.
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.

Nice To Haves

May be necessary to work extended hours as needed.
May be require weekend work.

Responsibilities

Assist in method 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
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 product
Prepare and review final validation summary reports for clients
Perform and/or assist in investigations
Perform 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 media qualification (Sterility and Growth promotion)
Support microbiological testing on facility water (WFI, CS, etc.) and biological indicators
Record and review data following GDP
Support writing and review of protocol, standard operating procedure and work instructions
Performs technical review of test results for completeness and compliance to GDP to ensure that documentation, controls and traceability are in place to maintain integrity
Prepares and reviews in-house media, reagents, and test samples as required
Prepare microorganisms for identification, perform Gram staining. Perform and interpret microbial identification results
Performs sample receipt, manages and disposes analyzed samples as needed
Perform and maintain laboratory and equipment cleanliness
Perform and maintain inventory of microbiology supplies and lab stocking
Perform and assist with microbiological trend reports as required
Must be proficient in training new and existing employees
Assist in regulatory audits
Understand and demonstrate aseptic technique
Proficient in membrane filtration in relation to sterility and bioburden testing
Familiar with GxP (Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice)