Responsible for performing routine testing of in-process and finished product samples. Summarizes environmental monitoring and product test results. Provides project support to Scientist, Lead Scientist, and Senior Scientist, as needed. Performs AQL visual inspection.
• Performs routine testing of in-process and finished products and provides support for protocols for product validation and environmental monitoring.
• Performs AQL visual inspection.
• Performs microbial enumeration and gram staining, and growth promotion testing, as needed.
• Performs duties related to sample receipt, shipping to contract laboratories, and disposal of sample retains
• Must be able to understand and follow good documentation practices
• Assists Scientist / Lead Scientist / Senior Scientist with test method validations and special projects related to environmental monitoring or sterility testing.
• Monitors and tracks microbiological test results.
• Conducts routine entries for summaries of test results for trend analysis.
• Promptly reports data discrepancies and out of limits conditions to supervision.
• Provides edits for standard operating procedures for microbiology test procedures as well as other Quality Control documentation.
• Carries out documentation, investigation, author incident reports, and conducts corrective actions under management supervision.
• Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.
• Maintains knowledge of cGMP and is required to keep current on training and training assignments.
• Follow safety requirements, maintain good housekeeping of laboratory areas, orders laboratory supplies to maintain inventory and prepares test media and reagents as assigned.
• Participates in any and all reasonable work activities as assigned by management.
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· Bachelor of Science degree in a biological science with 3-5 years progressive laboratory experience. Equivalent combination of education and experience accepted.
· Excellent verbal and written communication skills are essential.
· Planning and organizational skills necessary for primary responsibilities.
· Must successfully execute requirements to achieve ISO 5 environment gown certification as required by supervision.
· Trained in cGMP.
· Ability to work interdepartmentally and communicate effectively with various departments.
· Excellent attention to detail.
· Ability to excel in in a fast pace environment.
· Excellent organization skills.
· Ability to prioritize tasks.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.