GMP Microbiology Lab Analyst

4 weeks ago

Omaha, United States Midwest Laboratories Full time
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.

  • Lab Support Assistant

    4 weeks ago

    Omaha, United States Nebraska Medical Center Full time

    Serious Medicine is what we do. Being extraordinary is who we are. Every colleague plays a key role in upholding this promise to our patients and their families. Shift: Third Shift (United States of America) Lab Support Assistant - Microbiology Position Highlights: Nebraska Medicine is now taking applications for a talented individual to join us as a...

  • Lab Support Assistant

    3 weeks ago

    Omaha, United States Nebraska Medical Center Full time

    Serious Medicine is what we do. Being extraordinary is who we are. Every colleague plays a key role in upholding this promise to our patients and their families. Shift: Third Shift (United States of America) Lab Support Assistant - Microbiology Position Highlights: Nebraska Medicine is now taking applications for a talented individual to join us as a...

  • Microbiology Lab Tech Trainee

    2 weeks ago

    Omaha, United States Nebraska Medicine Full time

    Serious Medicine is what we do. Being extraordinary is who we are. Every colleague plays a key role in upholding this promise to our patients and their families. Shift: Third Shift (United States of America) Microbiology Lab Tech Trainee Position Highlights: Nebraska Medicine is now taking applications for a talented individual to join us as a ...

  • Pathogen Lab Analyst

    1 week ago

    Omaha, United States Certified Laboratories Full time

    Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro...

  • Biological Technician

    2 days ago

    Omaha, United States Food Safety Net Services Full time

    Job DescriptionJob DescriptionCertified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group...

  • Pathogen Lab Analyst

    3 weeks ago

    Omaha, United States Certified Laboratories Inc Full time

    Job DescriptionJob DescriptionCertified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.),...

  • Pathogen Lab Analyst

    4 weeks ago

    Omaha, United States Certified Laboratories Inc Full time

    Job DescriptionJob DescriptionCertified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.),...

  • Path Lab Analyst

    7 days ago

    Omaha, United States Food Safety Net Services Full time

    Job DescriptionJob DescriptionCertified Group is committed to delivering expert solutions and quality testing our customers can feel confident in – on time, every time – so the world can trust in what it consumes. As a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services, Certified Group...

  • Microbiology Technician- Overnight

    3 weeks ago

    Omaha, United States Food Safety Net Services Full time

    Job DescriptionJob DescriptionCertified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.),...

  • Microbiology Technician- Overnight

    4 weeks ago

    Omaha, United States Food Safety Net Services Full time

    Job DescriptionJob DescriptionCertified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.),...

  • Lab Technician

    4 weeks ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionHIRING IMMEDIATELY!! Multiple Lab Technicians Needed!! Are you a science minded candidate looking for a FUN position working with GREAT people? If so, keep reading!Work for one of the largest laboratories in the Midwest. Gain or grow your science knowledge with valuable, real world laboratory experience! Competitive pay and...

  • Lab Technician

    3 weeks ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionHIRING IMMEDIATELY!! Multiple Lab Technicians Needed!! Are you a science minded candidate looking for a FUN position working with GREAT people? If so, keep reading!Work for one of the largest laboratories in the Midwest. Gain or grow your science knowledge with valuable, real world laboratory experience! Competitive pay and...

  • Chemistry/Biology Laboratory Analyst

    1 month ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionHIRING IMMEDIATELY!! Chemistry/Biology Laboratory Analysts Needed!! Quickly growing organization looking to add multiple career-minded CHEMISTS and BIOLOGISTS to their team. Opportunities available for various levels of experience. Pay depending on experience. Endless opportunities to grow and use new instruments!Benefits of a...

  • Biology/Chemistry Laboratory Analyst

    4 weeks ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionHIRING IMMEDIATELY!! Biology/Chemistry Laboratory Analysts Needed!! Quickly growing organization looking to add multiple career-minded BIOLOGISTS and CHEMISTS to their team. Opportunities available for various levels of experience. Pay depending on experience. Endless opportunities to grow and use new instruments!Benefits of a...

  • Biology/Chemistry Laboratory Analyst

    3 weeks ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionHIRING IMMEDIATELY!! Biology/Chemistry Laboratory Analysts Needed!! Quickly growing organization looking to add multiple career-minded BIOLOGISTS and CHEMISTS to their team. Opportunities available for various levels of experience. Pay depending on experience. Endless opportunities to grow and use new instruments!Benefits of a...

  • Lab Manager

    2 weeks ago

    Omaha, United States Noll Human Resource Services Full time

    Job DescriptionJob DescriptionLab Manager Needed NOW!!HIRING IMMEDIATELY!! Are you experienced in Virus Production with proven ability to manage a team and looking for a GREAT company to continue your career?Work for a global animal health producer with a small company feel. AWESOME benefits if hired. Interested? Apply now!APPLY NOW!! Email your resume to...

  • Lab Tech- 2nd shift

    3 weeks ago

    Omaha, United States Food Safety Net Services Full time

    Job DescriptionJob DescriptionCertified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services. Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.),...

  • Lead Lab Tech

    4 weeks ago

    Omaha, United States Blue Bully Recruiting Full time

    Job DescriptionJob DescriptionCalling all experienced Lab Techs with virus production experience! We are a small but growing Animal Health Care company that specializes in the development and manufacture of vaccines for herd animals, primarily pigs and cows.  If you have a couple of years of experience working in a lab with mammalian cell culture and virus...

  • Quality Control Technician

    4 weeks ago

    Omaha, United States Actalent Full time

    JOB DESCRIPTION Description: Performs the following testing: 1.Purity testing, viscosity, appearance, pH and specific gravity on adjuvant samples2.Bacterial and viral inactivation testing3.Formaldehyde assays on vaccines and adjuvants4.Mycoplasma detection 5.Agglutination Testing6.Growth promotion 7.Preservative interference8.Protein binding9.Adjuvant...

  • Quality Control Technician

    3 weeks ago

    Omaha, United States Actalent Full time

    JOB DESCRIPTION Description: Performs the following testing: 1.Purity testing, viscosity, appearance, pH and specific gravity on adjuvant samples2.Bacterial and viral inactivation testing3.Formaldehyde assays on vaccines and adjuvants4.Mycoplasma detection 5.Agglutination Testing6.Growth promotion 7.Preservative interference8.Protein binding9.Adjuvant...