Scientific - Quality Control Scientist - Microbiology

Ampcus Inc.•Princeton, NJ

7d•Onsite

About The Position

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.

Requirements

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.

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.