The Microbiologist position must understand and follow Quality Manual and Methods relevant to the responsibilities to ensure integrity of test results. Must have the ability to read, understand and apply established protocols and Standard Operating Procedures to perform daily objectives. This position must demonstrate proficiency in aseptic technique, test method validation with a strong background in understanding and utilization of pharmaceutical cGMP as practical laboratory experience and knowledge to microbiological testing. The candidate will have excellent attention to detail, written and effective verbal communication skills with excellent problem-solving and ability to work in a fast-paced environment.
Role and Responsibilities
· Perform and document routine work assigned which includes operating analytical instruments in compliance with all applicable standard operation procedures, compendial monographs, policies, and regulations.
· Abide by ALOCA (Attributable, legible, contemporaneous, original and accurate).
· Able to comply and follow CGMP/GLP laboratory practice and documentation relevant to the duties and responsibilities assigned as well as able to comply with company’s requirements and regulations.
· Record in concise and detailed documentation in a laboratory notebook accordance with GMP.
· Document all observations in a laboratory notebook accordance with GMP.
· Perform calibration on basic and complex instruments as needed.
· Perform troubleshooting and maintenance on all analytical instruments.
· Required to accommodate business needs by executing time management skills and prioritizing tasks.
· Required to adjust workload based upon changing priorities.
· Able to adapt to changes with company’s policies and regulations.
· Maintain assigned instruments or assigned equipment as required/needed.
· Ensure testing and results are conducted and reporting without comprising quality and released in a timely manner to meet the deadline set, such as urgent, rush or standard turnaround time.
· Performs method development, verifications, and validations.
· Participates in writing, reviewing, and establishing methods, SOPs, deviations, out of specification investigations, change controls, and protocols.
· Works closely with QA and RA departments.
· Participates in audits and assists in improving laboratory procedures.
· Reviews data as required.
· Perform independently basic microbiological procedures, USP, FDA/BAM, Modified FDA/BAM, and Standard Methods testing.
· Duties include but are not limited to:
· USP <60> Microbiological examination of nonsterile products: Burkholderia cepacia complex (Bcc)
· USP <61> Microbiological examination of nonsterile products: microbial enumeration tests
· USP <62> Microbiological examination of nonsterile products: tests for specified microorganisms
· USP <2021> Microbial enumeration test – nutritional and dietary supplements
· USP <2022> Microbiological procedures for absence of specified microorganisms-nutritional and dietary supplements
· USP <51> Antimicrobial Effectiveness Testing
· USP <55> Biological Indicator Viable Spore Counts
· USP <1113> Microbial identifications
· USP <1116> Monthly lab monitoring
· USP Suitability of Test Methods in the Presence of Product <60>, <61> and <62>
· USP Preparatory Testing <2021> and <2022>
· USP <71> Sterility Test
· USP <85> Bacterial Endotoxins Testing (Gel Clot, Turbidimetric, Chromagenic)
· USP Growth Promotion Testing
· Toxicity testing
· Listeria testing (in-house method)
· Participate in Validation/Equivalency study of the Soleris NG system
· Assist in investigations and deviations.
· Conduct microbiological testing including gram stain, microbial identification, growth promotion and microbial limits.
· Conduct environmental monitoring activities including air and surface areas within the microbiology laboratory and as requested for clients’ manufacturing areas according to quality and microbiology requirements.
· Performs identification of microorganisms.
· Test USP water and perform basic maintenance of water purification system on scheduled basis.
· Record and maintain accurate, up to date logs, notebooks, and equipment records.
· Perform experiments, make observations, and interprets results obtained and reports data directly into notebooks in accordance with Good Manufacturing
· Perform trending observations and notify quality assurance unit if counts are atypical based on history of previous results.
· Compare results to specifications and immediately reports any out of specification results to Laboratory Manager and Quality Assurance team.
· Support any corrective actions when required.
· Conduct test large volume of work both efficiently and accurately.
· Correctly uses aseptic technique, and other culture-based microbiology procedures while working in the microbiology laboratory.
· Execute multiple projects and meet timelines.
· Organize inventory of chemicals, media and supplies used in laboratory when needed.
· Perform administrative functions such as filling paperwork, photocopying, reviewing of data as needed to maintain efficient operation of laboratory.
· Maintain cleanliness of laboratory and being aware of health and safety issues.
· Work as a team: The collaboration of all departments to achieve a common goal or to complete a task in the most effective and efficient way.
· To accommodate business needs, which includes understanding how to prioritize daily tasks and be efficient with managing your time.
· Ability to accommodate urgent or rush projects.
The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.
· Bachelor’s Degree in microbiology, biology, or other relevant scientific discipline.
· At least 2 to 3 years of experience in the pharmaceutical/dietary industry.
· Experience in a cGMP environment.
· Strong verbal, written and organizational communication skills.
· Ability to work independently, take initiative and collaborate on team projects.
· Excellent understanding of laboratory safety practices.
· Exceptional work ethic and thrives in fast paced conditions.
The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.
WORK CONDITIONS AND PHYSICAL REQUIREMENTS
This position must work a minimum of 40 hours a week over a period of 5 days a week and may require additional hours to meet project deadlines. This position does not require traveling.
· Wear proper protective equipment.
· Sometimes exposed to loud sounds or distracting noise levels.
· Are often exposed to contaminants or hazardous conditions while conducting analyses.
· Work within several feet of others in the laboratory.
· Sit or stand for an extended period.
· Be able to lift objects up to 25 pounds.
· May have to crawl or climb to perform certain tasks like maintenance of an instrument.
· Repetitive tasks with few breaks.
This position has no supervisory responsibilities.
Special consideration will be given to applicants with experience related to the validation/USP Equivalency Study for the Soleris NG Rapid Micro system or its predecessors (BioLumix or Soleris).