Description:
Summary of Position:
Perform mixing and in-process testing of chemicals and reagents to be used in clinical diagnostic and research kits. Create, prepare, and maintain documentation for Manufacturing Department.
Essential Functions, included but not limited to:
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Create, revise and/or edit technical documents such as SOPs, work instructions, validation protocols, NCRs, TDNs, change controls, etc.
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Create, stage and report work orders in the ERP system.
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Review inventory quantities in ERP system to determine stock levels and reorder points.
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Conduct monthly inventory of consumables; submit approved purchase orders to Procurement.
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Weigh, prepare and mix raw chemicals in laboratory and/or clean rooms in accordance with standard operating procedures (SOPs) and manufacturing instructions.
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Wash, sanitize and set up manufacturing equipment used in making reagents.
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Prepare samples for testing in laboratory by measuring out appropriate amounts of reagents in labeled containers.
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Store chemicals in designated locations according to chemical classification, temperature, etc.
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Clean equipment and work areas to prevent contamination from previous batches of chemicals upon completion of each assignment.
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Perform necessary functions of Non-Conforming Reports (NCRs) as needed for completion.
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Follow process for filling liquids by referring to work order; Record weights, document means of dispensing and equipment used.
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Identify concerns or discrepancies with all paperwork and quality; communicate situation with urgency to Manufacturing Manager.
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Perform laboratory equipment calibration in accordance with specifications.
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Maintains required logs and other records accurately and completely.
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Train new employees and be able to explain processes and procedures clearly.
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Adhere to current Good Manufacturing Practices (cGMP).
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Comply with Company policies and Standard Operation Procedure (SOPs).
Requirements:
Required Qualifications:
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Bachelor's degree in a science related field.
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Legally authorized to work in the United States.
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Proficient in Microsoft Excel, Word, and Outlook.
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Strong knowledge of biological and/or chemical concepts.
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Prior experience using pipettes.
Preferred Qualifications:
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Laboratory experience in a biology, chemistry, or medical environment.
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Experience in change management, root cause analysis, risk assessment, and out-of-specification (OS) investigations.
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Knowledge of various standards and regulations such as ISO 9001, ISO 13485, the Quality System Regulation (21 CFR Part 820).
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Experience in a cGMP environment.
Basic Skills and Abilities:
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Detail oriented, accurate, efficient, and accountable.
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Proven ability to meet deadlines; work in a fast-paced environment.
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Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
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Ability to work independently and as a member of various teams and committees.
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Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
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Ability to operate related office equipment, such as computer, calculator, and copier.
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Demonstrated ability to analyze and interpret information.
