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Scientist, Analytical R&D (Microbiologist) Onsite

Primary Talent Partners

Rahway, NJ

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JOB DETAILS
SALARY
$27–$32 Per Hour
SKILLS
Analysis Skills, Analytical Development, Asepsis, Biology, Biotech and Pharmaceutical, Cleanroom, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Management, Data Quality, Documentation, Environmental Microbiology, Environmental Monitoring, External Audit, GMP (Good Manufacturing Practices), Human Health, Internal Audit, Interpersonal Skills, Inventory Management, Laboratory, Laboratory Information Management System (LIMS), Laboratory Techniques, Laboratory Testing, Maintain Compliance, Manufacturing, Microbiology, Mobile Applications, Operational Support, Organizational Skills, Presentation/Verbal Skills, Problem Solving Skills, Product Testing, Quality Assurance Methodology, Quality Control, Regulatory Compliance, Research & Development (R&D), Root Cause Analysis, SAP, Sales Pipeline, Specimen Collection, Standard Operating Procedures (SOP), Team Player, Testing, Trend Analysis, Virtual System Managers, Water For Injection (WFI), Writing Skills
LOCATION
Rahway, NJ
POSTED
2 days ago
Primary Talent Partners has a new contract opening for a Scientist, Analytical R&D (Microbiologist) – Onsite to join our pharmaceutical client in Rahway, NJ. This is a 12-month contract to start with the potential for extensions. 

Pay:$27.00 - $32.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Schedule: Monday-Friday | Onsite role

Description:
The Analytical Research and Development Microbiology group has an opening for a Scientist - Microbiologist. Join us and experience our culture first-hand one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

In your role as Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory, including finished products testing, utilities, and environmental monitoring. While working within a fast-paced, integrated, multidisciplinary team environment, the candidate is expected to have a strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures.


Primary Responsibilities:
  • Perform routine viable and non viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment.
  • Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements.
  • Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools).
  • Execute aseptic sampling techniques to ensure data integrity and contamination free sample collection.
  • Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.
  • Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
  • Trend, analyze, and interpret EM data; escalate atypical or out of trend (OOT) results and support investigations.
  • Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.
  • Maintain accurate documentation of sampling activities in compliance with ALCOA and data integrity principles. Inventory management.
  • Conduct microbiology finished goods testing and biological indicator (BIs) testing
  • Support of sterile operations within the quality control department including utilizing isolator for sterility testing, conduct suitability testing method, endotoxin, microbial enumeration, media / reagent quality control testing.
  • Experience with testing in clean room environments preferred
  • Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
  • Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations.
  • Perform second scientist review microbiology experiments in line with GMP expectations
  • Support internal and external compliance audit activities.
  • Conduct other job duties as per management assignments/business requirement.


Qualifications:
  • Team fit requires a team player, adaptable, coachable, proactive, quality mindset.
  • Candidates must have GMP experience, environmental monitoring, and MODA/SAP/LIMS familiarity.
  • PhD candidates are overqualified and not targeted for this role.
  • Interviews will be virtual, manager screening, then possible team rounds.
  • Preferred candidate should have GMP industry experience, a minimum bachelor's degree, and skills in microbiological testing and environmental monitoring.
  • Candidates will use MODA, a mobile data acquisition application, for entering test results and managing data.
  • Prior Environmental Monitoring experience is a plus. This position is based at the Rahway, New Jersey site.

Education Minimum Requirements:
  • Minimum 1 years of pharmaceutical industry experience for applicants with a MS degree or 2 years of experiences for BS degree in Microbiology or related Biological Sciences, or equivalent with direct microbiological testing GMP experience.


Required Experience and Skills:
  • A proven record of microbiology laboratory experience.
  • Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
  • Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment.
  • Knowledge of current microbiology industry guidelines and compendia


Preferred Experience:
  • Knowledge in sterile, nonsterile and aseptic manufacturing and associated GMP product testing
  • Experience in supporting quality investigations in microbiology discipline
  • Experience with MODA, SAP, Veeva, and LIMS is a plus.


Required Skills:
  • Adaptability, Biological Sciences, Environmental Monitoring, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Techniques, Microbiological Tests, Aseptic techniques, Standard Operating Procedure (SOP).
  • Interpersonal Relationship, Self-Motivation, Problem Solving, Communications, and Team Player.

Note: Occassional weekend support as needed.


Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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