Microbiology Analyst III

Epicur; Mount Laurel Township (NJ); On-site; USD 38,572 - 46,838; Full time

Job summary

Epicur in Mount Laurel, NJ is seeking a Microbiology Analyst III to develop procedures, perform investigations, and conduct routine analysis of raw materials and finished products on-site. Starting at $30 hourly, with two annual bonuses, the role involves method development for sterility, bioburden, endotoxin, and AET, along with other QC activities.

The position requires strong lab skills, attention to detail, and adherence to cGMP documentation practices to support audits and regulatory

Responsibilities

• Develop and validate sterility, bioburden, endotoxin, and particle size distribution methods.
• Support rapid sterility and bioburden testing using ATP bioluminescence techniques.
• Perform and review QC testing of finished products, raw materials, and components against specs.
• Lead data review, ensure cGMP compliance, and maintain documentation traceability.
• Prepare, review, and approve SOPs, work instructions, and test reports for clients.
• Train new staff on aseptic technique and lab safety protocols.

Skills

Sterility testing

Bioburden testing

Endotoxin testing

AET (Antimicrobial Effectiveness)

Aseptic technique

Membrane filtration

GxP knowledge

Job description

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

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