Microbiologist

LanceSoft Inc

Princeton, NJ

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Analysis Skills, Analysis Software, Analytical Chemistry, Asepsis, Assays, Biochemistry, Biotech and Pharmaceutical, Calibration, Cell Cultures, Change Control, Communication Skills, 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, Microbiology, Molecular Biology, Presentation/Verbal Skills, Problem Solving Skills, Product Positioning, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Risk Analysis, Safety/Work Safety, Standard Operating Procedures (SOP), Statistics, Team Player, Testing, Trend Analysis, Writing Skills

LOCATION

Princeton, NJ

POSTED

2 days ago

Title: Quality Control Scientist - Microbiology Location: Princeton, NJ 08540 Duration: 4 Months SHIFT MON-FRI 8AM - 4:30PM With Some Flex for OT or Weekends. Position 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 laboratorys 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. The Quality Control Scientist - Microbiology, Bioanalytical will report to the Supervisor, Quality Control. Key Responsibilities: Microbiology 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. Position requirements: Bachelors or masters 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.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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