Scientist II (4:00pm - 12:30am) - #1405359
Fagron
Date: 2 weeks ago
City: Canton, MI
Contract type: Full time

Who We Are
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally. About the job
The Scientist II is responsible for performing routine Microbiology testing of in-process and finished product samples. Summarizes environmental monitoring and product test results. Provides project support to other Scientist, Lead Scientist, and Senior Scientist, as needed. Role Responsibilities:
Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally. About the job
The Scientist II is responsible for performing routine Microbiology testing of in-process and finished product samples. Summarizes environmental monitoring and product test results. Provides project support to other Scientist, Lead Scientist, and Senior Scientist, as needed. Role Responsibilities:
- Performs routine testing of in-process and finished products and provides support for protocols for product validation and environmental monitoring.
- Performs microbial enumeration and gram staining, and growth promotion testing, as needed.
- 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.
- Generates standard test solutions as required.
- 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.
- Review work done by department staff for accuracy, completeness and conformance to specifications.
- 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 with primary support of management.
- Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department.
- Supports multiple projects or is a lead for one project within the Quality Control Group
- Willing to be a Qualified Trainer for any aspect of QC Microbiology
- 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. Set yourself apart
- Bachelor of Science degree in a biological science with 6-9 years progressive laboratory experience. Equivalent combination of education and experience accepted.
- 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 for at least 2 years.
- Experience reading SOP, PBR, MBR, Job Aids and Training Modules is a plus.
- Excellent attention to detail.
- Superb verbal and written communication skills.
- Proficiency in planning, organization, communicative, and teamwork skills are necessary for primary responsibilities and amongst coworkers.
- Ability to work with minimal supervision and to take initiative is preferred.
- Ability to excel in a fast-paced environment. What's on offer?
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