Piper Companies is seek a QC Microbiologist Analyst in Princeton, NJ to join a clinical stage bio-pharmaceutical company developing innovative therapies for cancer diseases.
The QC Mirco Analyst performs testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
Responsibilities include, but are not limited to, the following:
- Reviews and updates SOPs.
- Performs peer review of data.
- Performs laboratory investigation reports.
- Participates in training of other employees.
- Performs microbial identification procedures.
- Participates in the overtime and weekend schedule as required.
- Performs bioburden and endotoxin testing of products and raw materials.
- Performs microbiological testing of in-process and final product materials.
- Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment.
- Updates microbiological environmental monitoring results database and prepares monthly report.
- Has good Aseptic Technique and knowledge
- Has good Attention to Detail
- Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking.
- Performs all duties relevant to the Quality Control Microbiology Technician position as required.
- Performs routine and specialized evaluations of finished products, stability and special project test samples.
- Applies sound, scientific principles to solve problems.
- Provides technical training support as required.
- Microbiology representation and participation in cross functional site meetings.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
Knowledge, Skills & Abilities:
- Ability to maintain integrity and honesty at all times
- Ability to work independently or as part of a team
- Ability to communicate with transparency
- Continuously drive to improve processes for improved performance
- Demonstrate respectful behavior at all times
- Ability to multi-task
- Ability to analyze and identify trends
- Develops and delivers effective presentations
- Problem-solving skills
- Ability to train others on basic systems and processes
- Strong written communication
- Ability to work in an ever-changing environment
- Critical thinking skills
- Knowledge of aseptic techniques preferred
- Knowledge of bioburden and endotoxin testing preferred
Education and Experience:
- BS/BA in Life Sciences or equivalent and 0-2 years of related experience
- Salary $45,000-$50,000
Please email qualified resumes to Karen Pallone at firstname.lastname@example.org