Microbiology Laboratory Analyst II/III - Senior Analyst

Description:

Pacific BioLabs is an independent CRO offering cGMP/GLP testing services in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. Founded in 1982, PBL is beginning a new chapter, applying significant investment and energy towards modernizing workflows, upgrading facilities and most importantly, enhancing our employee experience. We are looking for talented, energetic scientists and professionals to share in our passion for our mission to enhance public health through the testing services we provide to our pharma, biotech and medical device clients. If you are up for a challenge, come join our team!

PBL has an immediate opening for a fulltime onsite Microbiology Laboratory Analyst II/III or Senior Analyst, depending on experience, in the Microbiology Services Department. The Microbiology Laboratory Analyst II/III or Senior Analyst will report to the Director of Microbiology and will contribute to general and complex laboratory testing, sample management and laboratory maintenance. The Microbiology Laboratory Analyst or Senior Analyst is expected to participate with the team to meet Microbiology Services Department goals and perform routine and non-routine laboratory duties as directed. As a member of the PBL Microbiology Services team, the Analyst will make contributions to the growth of the department primarily through laboratory testing, training peers, validations, and support of the company's continuous improvement initiatives and client needs. This position is client-facing, and the analyst must be quality focused and work in accordance with the PBL Quality Management System.

PRIMARY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Perform microbiological tests in strict accordance with SOPs, cGMP, cGLP, USP, EP, ISO/IEC 17025, and other applicable regulatory requirements that support client release of intermediates and/or finished products:

-Container Closure Integrity Test (CCIT)

-Package Integrity Evaluation

-Cleaning and disinfection validations (manual and automated)

-Bioburden USP 61, 62

-Heterotrophic plate count (HPC) USP 1231

-Endotoxin USP 85

-Sterility assurance USP 71

-Antimicrobial Preservative Efficacy Testing (APE) USP 51 USP-EP

-Total Organic Carbon (TOC) USP 6643

-Conductivity, pH

• Custom studies and additional testing based on client requests
• Perform environmental monitoring per ISO 14644, water and critical utility sample collection
• Perform method development, modification, verification and assist with method validation testing
• Participate in method transfer activities and suitability studies under guidance from leadership
• Support Quality Management System investigations for non-conformance / out of specification results including but not limited to Environmental Monitoring, Bioburden, Sterility Assurance, Growth Promotion etc.
• Complete assigned CAPA tasks and change controls
• Ensure laboratories are clean, safe, and in compliance with cGMP
• Perform regular inventory of reagents, consumables and materials
• Make in-house reagents, stock solutions, media and microbial suspensions
• Perform dry goods, liquid media and biowaste autoclave sterilization cycles and other laboratory housekeeping tasks
• Maintain accurate and complete test records
• Always be audit ready
• Provide results within pre-determined turnaround time (TAT) and ensure that results are right the first time
• Maintain positive/professional relationships with clients and co-workers
• Stay current with regulatory and industry standards, trends, and advancements as they pertain to testing in the Microbiology Services Department
• Additional responsibilities related to job function

Requirements:

QUALIFICATIONS:

Education/Experience

• MS/PHD in Biology, Pharmaceutical Sciences, Biotechnology or equivalent - Microbiology degree preferred with 1+ years' relevant experience in microbiology or;
• BS/BA in Biology, Pharmaceutical Sciences, Biotechnology or equivalent - Microbiology degree preferred with 4+ years' relevant experience in microbiology or;
• Associate degree in related scientific discipline and 5+ year of experience in Microbiology or related scientific field laboratory or;
• High school diploma and 7+ years of experience in Microbiology or related scientific field laboratory
• 2+ years GMP/GLP laboratory/FDA experience required
• Related training certifications and self-learning are a plus
• Local candidates (San Francisco Bay Area) preferred

Technical Skills

• Excellent documentation and writing skills
• Effectively operate in an evolving, complex and dynamic environment that changes by the hour
• Advanced math skills
• Proficient in aseptic technique
• Clean room experience

Interpersonal Skills

• Organizational skills
• Excellent written, verbal and communication skills
• Ability to work in a multi-cultural environment
• Creative, detail oriented and problem-solving skills
• Goal orientated and eager to learn
• Ability to multitask, time management and efficient
• Self-motivated

Physical Abilities

• Ability to lift 30 pounds and stand for extensive periods of time (up to 6 hours)
• Utilize ergonomics to perform repetitive motion tasks with hands and arms
• Able to work in a BSC/LAF/clean room
• Fully gown to enter the sterility suite which requires balance and coordinated movements
• Capable of working at the lab bench for most of the day (up to 8 hours)

Safety/Hazards Information

• Ability to tolerate the smell of Gram-negative organisms and laboratory disinfectants
• Able to work safely with Biosafety Level II (BSL II) microorganisms and bloodborne pathogens

Additional Information

• Able to effectively navigate computer systems
• Ability to work off shift hours and weekends when needed

The pay range for this position is $70,000 to $110,000 paid on hourly basis excluding overtime. The base pay offered will take into account internal equity and also may vary depending on the candidate's job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.

Pacific BioLabs is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected factors.

PM21

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