Microbiology Analyst III

Stokes Pharmacy•Mount Laurel Township, NJ

13d•Onsite

About The Position

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. This role requires the ability to work on-site in Mount Laurel, NJ. The position offers a starting salary of $30 hourly, depending on experience, plus two bonuses per year.

Requirements

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
Develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
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)

Nice To Haves

Experience with LIMS preferred

Responsibilities

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