What are the responsibilities and job description for the Manufacturing Chemist position at EKF Diagnostics USA (Stanbio Laboratory)?
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
Required Qualifications:
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.
- 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.
- 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.