Description

The GMP Microbiology Lab Analyst will perform microbiological assays, related to bioburden testing, utility monitoring, raw material, and finished product testing in accordance with cGMP/FDA regulations as they apply to the pharmaceutical industry. Responsibilities may include, but not limited to, environmental monitoring of controlled environments, cleaning and equipment maintenance, logging in samples, receiving laboratory supplies, microbiological testing and analysis (bioburden testing, plate enumeration, growth promotion, Gram-stain, microbiological identification) on a variety of sample types related to pharmaceutical production. Schedule will be Mon-Fri and rotational weekends.

SPECIFIC DUTIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Conduct analyses on raw materials, in-process samples, final product samples and other samples collected from manufacturing areas. 
• Follow all PPE requirements and guidelines to maintain the cleanliness and integrity of the controlled environment including lab coat, hairnets, glasses/googles, booties, and arm sleeves.
• Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Perform daily work assignments aseptically, accurately, and in a timely and safe manner.
• Use laboratory instrumentation including analytical equipment, autoclaves, and incubators.
• Maintain a laboratory notebook and complete all laboratory documentation in clear and accurate language according to applicable SOPs and cGMP guidelines.
• Uphold data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, cGMP's, FDA, USP, and GxP regulations.
• Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QC and issuance to customers.
• Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Supports the department in ensuring continuous test operation, good performance, maintenance, and housekeeping of laboratory equipment and facilities.
• Investigate nonconformances and write exception documents.
• Work on multiple tasks concurrently including routine monitoring, sample testing, special project, protocol testing in a timely and appropriate manner.
• Participate in functions involving teams, which impact production, increase efficiency, generate cost savings, and improve quality.
• May prepare monthly quality trend reports. Trend analytical data, create trending reports, and maintain notebooks/ logbooks.
• Perform equipment cleaning, maintenance, and calibration. Maintain equipment logbooks for traceability of all use and maintenance activities. 
• Remain up-to-date on all required training.

Requirements

Education and Training:

• BS in Microbiology or related sciences including, but not limited to Chemistry, Biology, Biochemistry, Biophysics, Molecular Biology, Pharmacology.
• Knowledge of GMP and ISO standards preferred
• Knowledge of Environmental Monitoring, including, but not limited to, viable air sampling, contact sampling, surface sampling.

Knowledge and Skills:

• Advanced laboratory skills
• Good analytical, writing (GDP), interpersonal and organizational skills.
• Proven technical writing skills (SOPs, protocols, deviations/ nonconformances, OOS investigations).
• Strong computer skills including software packages supporting data analysis, word processing, and project management programs.
• Strong analytical problem-solving skills
• Ability to follow established procedures and guidelines.
• Ability to meet deadlines.
• Strong ability to multi-task and prioritize.
• Exceptional attention to detail
• Self-motivated, with the ability to work independently and as part of a team.
• Ability to exhibit punctuality and low absenteeism.
• Service oriented attitude.

Experience:

• A minimum of 3-4 years of relevant experience within the pharmaceutical industry in an FDA registered cGMP microbiology laboratory. 
• Firsthand experience with USP 61 and USP 62 Microbial Limits Testing for finished drug products.
• Knowledge of USP 1115 Bioburden Testing; USP 1111 Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical use. 
• Understanding of cGMP's, FDA, USP, and GxP regulations as they apply to the pharmaceutical industry.

Physical Requirements:

• Physical dexterity sufficient to use hands, arms and shoulders repetitively to operate a keyboard and other office equipment
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure accurate exchange of information in normal conversational distance, over the phone and in group setting
• Ability to stand for extended periods of time as necessary in the laboratory (6 or more hours)
• Ability to lift and move items weighing up to 15 pounds
• Physical dexterity sufficient to move body frequently around laboratory equipment and instrumentation
• Ability to continuously operate a personal computer for extended periods of time (2 or more hours)
• Mental acuity sufficient to collect and interpret data, evaluate reason, define problems, establish facts, draw valid conclusions, make valid judgement and decisions

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.