Job DescriptionAre you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a Microbiologist I
to join their New Brunswick, New Jersey team
. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.Direct Hire
Pay Rate : DoE
Under the direction of Senior Associate or Manager - Quality Control Microbiology Laboratory (QCML), this individual performs microbiological analysis of stability samples, raw materials, environmental monitoring samples, water samples, Cleaning Validation and Verification swabs, in-process samples and finished products in the QCML. Write analytical reports and investigatory documents, as needed, using appropriate technical terminology and with scientifically sound explanations and justification of any conclusion(s). Conduct method validations per established procedures and methodology.Area of Responsibility
- Coordinate receipt of raw material, in-process and final product samples for testing.
- Acts QCML liaison with outside contract services laboratories.
- Accountable for microbiological analysis of Cleaning Validation and Verification swabs, stability samples, raw materials, in-process samples and finished products in the QCML.
- Perform and review growth promotion testing data for qualification of microbial culture media.
- Provides microbiological testing for new product validations and launches when necessary.
- Ensure that QCML is cGMP compliant at all time.
- Calibration of laboratory equipment and instruments as needed.
- Equipment validation (IQ, OQ, PQ) and troubleshooting.
- Environmental monitoring of production facilities.
- Microbiological testing of the water system.
- Perform development, maintenance, review, reporting and verification of documents.
- Maintain/source laboratory equipment, inventory and supplies.
- Interpretation of complex data and analysis.
- Investigation of OOS (Out of Specification) and OOT (Out of Trend) results and other associated discrepancies.
- Maintain records in paper based or computer-based systems
- Performs other duties as assigned by Departmental Manager. Act as a subject matter expert in absence of another Microbiologist (s)/ Manager.
Environmental related to manufacturing/production environments:Required Qualifications:
- Bachelors in Microbiology (Masters' preferred).
- Minimum 4 years in a Pharmaceutical Industry or in a cGMP laboratory environment.
- Strong technical knowledge of microbial testing methodologies e.g. (USP, EP, JP etc.).
- Basic Knowledge of computer systems (MS word, Excel, power point etc.).
- Microbiology problem solving skills.
- cGMP, Environmental Monitoring.
- Identification of Isolates.
- Strong Interpersonal skills.
- Strong written and verbal communication skills.
- Meeting deadlines and tasks
- Knowledge of ICH and FDA regulatory guidance.
- Must be familiar with cGMP/GLP concept or practices for microbiology laboratories and EHS/OSHA safety regulations.
- People based qualities: Good communication and writing skills, respect to others, positive attitude, team work, quick learner.
Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.