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QM Associate ScientistApply Now Job ID R-21551 Date posted 10/12/2017
Job Description SummaryThe QM Associate Scientist is responsible for applying basic scientific principles to routine laboratory work and for gaining experience in the application and interpretation of the department procedures.
- Will perform assigned routine laboratory tasks and learn the application of Quality procedures to ensure compliance. Works with SAP enterprise system to enter laboratory data and release material. Typically involved in routine testing of products and supplier materials and/or stability testing. Implements tasks and participates on teams.
- Ensures documentation compliance and process documentation. Interaction limited to areas such as Operations and other Quality groups.
- Performs a variety of assignments within the QC lab in support of assigned plant operations to ensure the highest standards are met for products. This includes testing of raw materials, work-in-progress and finished goods using a variety of testing techniques.
- Performs general laboratory duties (i.e. management of product retentions, lab cleaning, etc.) as directed by departmental SOPs.
- Handles hazardous materials, including chemicals and infectious agents, in the proper manner as established by safety and company policy.
- Assists in documentation writing & revising including test methods, final product specifications, SOPs, etc. as required.
- Assists in completing tasks in project protocols, change notifications, deviation waivers and Quality Notifications with supervision.
- Will work as member of ID/AST Quality Control team to perform bench-top testing of primarily Phoenix system disposables including panels, broths, and indicators. Other testing may involve Crystal, MicroCount, and/or "RMT" product lines. Other lab duties as assigned, including management of product retentions, streaking of microbial culture plates used in daily testing, and pH testing.
KNOWLEDGE AND SKILLS:
- Experience working in laboratory setting, prior experience working with microbial cultures and general microbiology techniques preferred.
- Knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR (Quality System Regulation), ISO (International Organization of Standardization).
- Knowledge of PC spreadsheet, word processing, and database applications.
- Excellent verbal and written communication skills.
- Good problem solving skills with the ability to make independent decisions.
Bachelor's Degree in Biology, Microbiology or other related field.
1-2 years' related experience preferred.
Primary Work LocationUSA MD - Baltimore
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