US ~ Boothwyn, PA
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- Analytical method development, validation, and transfer activities.
- API/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testing.
- Notebook/report review, training, technical writing activities.
- Implementing, testing, using, or administrating LIMS.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Independently perform routine microbiological testing procedures in support of clinical manufacturing (API/raw materials, and drug products) according to SOPs, USP/NF, EP, and JP compendia guidelines, and standard test methods
- Environmental Monitoring of manufacturing facility including viable surface sampling, viable air sampling, non-viable air sampling and compressed air testing
- Author semi-annual and annual reports for Environmental Monitoring
- Evaluate limits and industry expectations for Environmental Monitoring as needed and justify procedure, limits, etc., as required.
- Document test results in laboratory notebook, in real-time, and communicates status of test results to supervisor.
- Maintain control of all project related samples submitted to the laboratory.
- Write and review analytical reports and author technical reports.
- Communicate with Clients regarding project timelines, data and ongoing studies.
- Review peer notebooks and analytical reports.
- Develop and identify training for other personnel
- Implement, test, use, or administrate LIMS
- Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
- Comply with all company and site policies and procedures.
- Manage responsibilities and works in an efficient manner to assure accurate and timely data reports.
- Order and maintain adequate supply of chemicals and general lab supplies to support microbiological testing.
- Independently resolve any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy.
- Remain current in profession and industry trends
- Make a positive contribution as demonstrated by making suggestions for improvement
- Learn new skills, procedures and processes including aspects of formulation development
- Is available for other duties as required
- Is available for overtime as needed
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Requires B.S. in Microbiology, Chemistry, Pharmacy or equivalent with at least 5 years of industrial pharmaceutical microbial laboratory experience.
- Full knowledge of fundamental microbiology procedures and techniques including aseptic technique, plate count procedures, and organism identification procedures is required.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.