API/QCI Supervisor
Job brief
- Responsible for the release of raw materials, components, and finished products from QCI in a timely manner.
- Responsible for the release of in process and finished product results from API in a timely manner
- Owner of equipment within QCI and API Microbiology, perform OOT investigations as needed
- Perform or delegate BMS investigations
- Perform or delegate OOT investigations for equipment
- Review and Approve API Microbiology OOS investigations
- Owner of DMR system and support for Change notification process
- Perform or delegate DMR investigations
- RMA review and approval
- Oversight of all specification for receiving items/materials at site
- Supervise a group of 6 individuals that are in 3 different categories that are intertwined: API Microbiology, QCI, QC Material specialist.
- Organize and coordinate day to day operation such as work planning and workload prioritization.
- Coordinate time off to ensure coverage for workload.
- Work in cross departmental teams to assist with projects and high priorities for the business (on average week con
- This individual will also supervise API Microbiology Laboratory and QCI personnel, conduct performance evaluation and ensure personnel training.
- Responsible for keeping track of Key Performance indicators
Requirements
- Minimum of five years of experience in a laboratory environment
- Must demonstrate understanding in microbiology laboratory techniques such as bioburden testing, identification of fungal and bacterial organisms, identification of pollens, identification of mites/insects, purity checks for products, environmental monitoring, and aseptic technique.
- 2-3 years of document review for release of data, materials or products
- 2-3 years of Supervisor experience or direct oversight of a minimum of 6 individuals
- Familiar with Good documentation practices
- Familiar with Quality System forms-Deviation Investigations, Event Investigations, Management of Changes, Building Management System Out of Specifications, Out of Tolerance Investigations, Microbiology Out of Specifications
- Should have experience with Documentation Revision in a quality system
- Knowledge of JDE database
- Mastercontrol
- Any experience with Return Material Authorization (RMA)
- Discrepant Material Investigations
Education Requirements
This position requires the following minimum education:
- Baccalaureate degree in Science/ Preferably in Microbiology
About STALLERGENES GREER International AG
Stallergenes Greer is an international biopharmaceutical company specialized in the research, diagnosis and treatment of respiratory, food and venom allergies through the development and marketing of Allergenic Immunotherapy treatments.
Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.
Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.
With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 44 countries.
Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment?
Join our Stallergenes Greer teams!
- Job category : Other
- Job type : Full time
- Contract type : Permanent contract (CDI)
- Job location : United States
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