Current jobs related to Microbiologist - Concord - Prime Analytical Laboratories, LLC

Job DescriptionJob Description

Prime Analytical Laboratories, LLC (PAL) is a fast-growing contract testing laboratory located in Concord, California. PAL provides analytical and microbiology testing services to cosmetics, nutraceuticals, medical devices, BioPharma, and dietary supplements. We are seeking a Microbiologist with excellent microbiology knowledge to perform microbial testing of different product and design microbiology studies. The person must provide excellent organization and works to ensure the lab complies with FDA GMP, ISO 17025 requirements, and safety practices. You will promote teamwork to ensure lab production meets the company goals. You will lead by example by working hard and with great attention to detail. This is a great opportunity for professional growth.  We offer competitive pay, annual bonus, and health benefits.

Duties

The Microbiologist duties include the following activities:

• Ensure lab complies with FDA GMP, ISO 17025 requirements, and safety practices.
• Prepares study protocols, SOP’s, COA’s and reports
• Reviews and approved test records
• Follows protocols and procedures as needed
• Oversee lab technicians performing different tests:
• Performs testing such as:
  • Aerobic and yeast and mold count based on AOAC, EU, USP, and FDA BAM methods.
  • Testing for presence or absence of pathogen such as E. coli, Staph. Aureus, Candida, Listeria, and other pathogens based on AOAC, EU, USP, and FDA BAM methods.
  • Disinfectant studies
  • Container closure microbial studies
  • USP , , , , , , , , and
  • Antimicrobial product efficacy studies
  • Coordinate field environmental monitoring sampling at client facilities (clean rooms, water systems and compressed air systems).
  • Custom microbial studies
  • DNA based pathogen screening tests
• Set-up Q-PCR pathogen screening laboratory
• Perform testing indicated above as needed
• Coordinate EM technicians traveling to client facilities to perform microbial sampling of compressed gases, manufacturing swabs, water systems, and clean rooms.
• Provides input and suggestions as part of the company’s continuous improvement process.
• Prepare lab metrics reports documenting lab performance.
• Work with clients to develop protocols that meet client needs
• Other duties as assigned

Requirements

Minimum BS degree in science with a concentration in microbiology, graduate degree in microbiology is a plus.  The position requires at least 5years of hands-on experience in microbiology testing in an FDA GMP regulated. Hands on experience in endotoxin, sterility, cleanroom EM, EM validations, water testing, disinfectant studies, and USP microbial methods. Experience performing USP, FDA BAM, AOAC, and ISO microbiology test procedures for biotech, pharmaceutical, and other FDA regulated products.

Other requirements:

• Excellent organizational skills along with good written and verbal communication skills in English.
• Excellent math skills.
• Ability to follow instructions and work as a team member.
• Valid driver’s license required.
• Ability to work overtime and weekends as needed to complete projects.
• Ability to work in a fast-paced environment.
• Must be able to work legally in the US
• Physical requirements – the ability to work and perform repetitive movements such as typing or pipetting, lift 25 pounds, ability to count colonies with normal lab equipment, stand for a long period of time, be able to gown to enter clean room areas and discern color.

 

Company Descriptionrime Analytical Laboratories, LLC (PAL) provides analytical chemistry, cleanroom EM monitoring, and microbiology lab testing services for Biotech, Pharma, compounding pharmacies, peptide products, cosmetics, dietary supplements, and other types of productsCompany Descriptionrime Analytical Laboratories, LLC (PAL) provides analytical chemistry, cleanroom EM monitoring, and microbiology lab testing services for Biotech, Pharma, compounding pharmacies, peptide products, cosmetics, dietary supplements, and other types of products

---