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:

• Create, revise and/or edit technical documents such as SOPs, work instructions, validation protocols, NCRs, TDNs, change controls, etc.
• Create, stage and report work orders in the ERP system.
• Review inventory quantities in ERP system to determine stock levels and reorder points.
• Conduct monthly inventory of consumables; submit approved purchase orders to Procurement.
• Weigh, prepare and mix raw chemicals in laboratory and/or clean rooms in accordance with standard operating procedures (SOPs) and manufacturing instructions.
• Wash, sanitize and set up manufacturing equipment used in making reagents.
• Prepare samples for testing in laboratory by measuring out appropriate amounts of reagents in labeled containers.
• Store chemicals in designated locations according to chemical classification, temperature, etc.
• Clean equipment and work areas to prevent contamination from previous batches of chemicals upon completion of each assignment.
• Perform necessary functions of Non-Conforming Reports (NCRs) as needed for completion.
• Follow process for filling liquids by referring to work order; Record weights, document means of dispensing and equipment used.
• Identify concerns or discrepancies with all paperwork and quality; communicate situation with urgency to Manufacturing Manager.
• Perform laboratory equipment calibration in accordance with specifications.
• Maintains required logs and other records accurately and completely.
• Train new employees and be able to explain processes and procedures clearly.
• Adhere to current Good Manufacturing Practices (cGMP).
• Comply with Company policies and Standard Operation Procedure (SOPs).

Required Qualifications:

• Bachelor's degree in a science related field.
• Legally authorized to work in the United States.
• Proficient in Microsoft Excel, Word, and Outlook.
• Strong knowledge of biological and/or chemical concepts.
• Prior experience using pipettes.

Preferred Qualifications:

• Laboratory experience in a biology, chemistry, or medical environment.
• Experience in change management, root cause analysis, risk assessment, and out-of-specification (OS) investigations.
• Knowledge of various standards and regulations such as ISO 9001, ISO 13485, the Quality System Regulation (21 CFR Part 820).
• Experience in a cGMP environment.

Basic Skills and Abilities:

• Detail oriented, accurate, efficient, and accountable.
• Proven ability to meet deadlines; work in a fast-paced environment.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
• Ability to work independently and as a member of various teams and committees.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Ability to operate related office equipment, such as computer, calculator, and copier.
• Demonstrated ability to analyze and interpret information.