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Quality Control Scientist - Microbiology

Aditi Consulting

Princeton, NJ

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JOB DETAILS
SALARY
$45–$48 Per Hour
SKILLS
Analysis Skills, Analysis Software, Analytical Chemistry, Artificial Intelligence (AI), Asepsis, Assays, Automotive Automation, Biochemistry, Biotech and Pharmaceutical, Calibration, Cell Cultures, Change Control, Communication Skills, Consulting, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Detail Oriented, Documentation, Droplet Digital PCR (ddPCR), Drug Manufacturing, Environmental Monitoring, External Audit, FDA (Food and Drug Administration), Industry/Trade Analysis, Internal Audit, Laboratory Equipment, Laboratory Operations, Manufacturing, Materials Testing, Mentoring, Messaging Technology, Microbiology, Molecular Biology, Presentation/Verbal Skills, Problem Solving Skills, Product Positioning, Purchasing/Procurement, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Risk Analysis, Safety/Work Safety, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Statistics, Team Player, Telephony, Testing, Trend Analysis, Writing Skills
LOCATION
Princeton, NJ
POSTED
10 days ago
Payrate: $45.00 - $48.00/hr.
 
Summary:
The QC Scientist – Microbiology, Bio-Analytical and Raw Material is responsible for performing microbiological, bio-analytical and raw material testing to ensure the quality and safety of products. The position involves routine testing of raw materials, in-process samples, and finished products, as well as environmental monitoring and support for aseptic control. The QC Scientist will collaborate with cross-functional teams, participate in investigations of deviations and non-conformances, and contribute to continuous improvement initiatives. This role demands a thorough understanding of regulatory requirements and compliance with standard operating procedures (SOPs). Additionally, the QC Scientist will mentor junior staff, support audits, and ensure proper maintenance and calibration of laboratory equipment, playing a key role in upholding the laboratory’s operational excellence.
The Quality Control scientist must be able to help the team with Raw material work by being responsible for ensuring the quality and compliance of raw materials used in pharmaceutical manufacturing. This role involves creating material specifications, conducting identification tests, and performing assays and impurity analyses according to established protocols and regulatory requirements.
 
Responsibilities:
  • Perform sterility testing, endotoxin testing, microbial identification, and routine microbiological testing on raw materials, in-process samples, and finished products.
  • Conduct compendial tests including BacT assay, Endotoxin, and Mycoplasma assay.
  • Support ongoing EMPQ, cleaning and disinfection, and improvement of aseptic control. Conduct environmental monitoring of manufacturing and laboratory areas.
  • Execute trend analysis of EM and sterility data and write monitoring reports. Suggest/initiate resolution plan based on risks identified.
  • Participate in investigations related to microbiological deviations, out-of-specification results, and non-conformances. Support CAPA, Change Control, and change action.
  • Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Research & Development.
  • Support developing and implementing the site Microbial Control Strategy from incoming raw materials through final product release. Perform growth promotion as release testing.
  • Analyze and interpret test results, documenting findings in compliance with SOPs and regulatory requirements.
  • Ensure laboratory equipment is calibrated, maintained, and functioning properly. Perform monthly and quarterly cleaning of refrigerators, incubators, and BSCs.
  • Stay current with industry trends, regulatory changes, and advancements in microbiological techniques.
  • Support internal and external audits by providing data and documentation related to microbiological activities.
  • Train and mentor other staff and new hires in microbiological techniques, laboratory procedures, and growth promotion.
  • Maintain the QC microbiological lab, ordering reagents, and logbook. Perform other duties as assigned.
 
Qualifications:
  • Bachelor’s or master’s degree in microbiology, Biochemistry, Analytical Chemistry, Molecular Biology, or a related field.
  • Minimum of 4-7 years of experience in a microbiology and/or bio-analytical laboratory, preferably in a pharmaceutical, biotechnology, or related industry.
  • Or in place of a degree, 10+ years of relevant experience.
  • Strong understanding of microbiological and bio-analytical techniques and principles, including aseptic techniques, ddPCR, Flow Cytometry, ELISA, Viability assay, and cell culture.
  • Experience with method development and validation in a regulated environment.
  • Familiarity with regulatory requirements (e.g., FDA, EMA) and cGMP guidelines.
  • Proficiency in using laboratory equipment and software for data analysis.
  • Excellent attention to detail and strong analytical skills.
  • Ability to troubleshoot and solve technical problems related to microbiological and bio-analytical testing.
  • Strong communication skills, both written and verbal.
  • Ability to work independently and as part of a team in a fast-paced environment.
  • Knowledge of statistical analysis and data interpretation.
  • Familiarity with quality management systems and continuous improvement processes.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $45.00 - $48.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
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