Chemist I

• The Chemist I is responsible for supporting laboratory manufacturing and testing operations in a GMP-regulated environment.
• This role performs reagent and solution preparation, in-process analytical testing, equipment maintenance, documentation, and quality compliance activities while contributing to manufacturing goals and continuous improvement initiatives.

Requirement/Must Have:

• Bachelor s degree in Chemistry, Biological Sciences, or a related scientific discipline.
• 0 2 years of experience in a laboratory environment.
• Knowledge of Good Manufacturing Practices (GMP).
• Ability to follow Standard Operating Procedures (SOPs) and batch records.
• Strong verbal and written communication skills.
• Ability to maintain accurate records, laboratory notebooks, and documentation.
• Proficiency with Microsoft Office and manufacturing systems.
• Strong attention to detail and organizational skills.
• Ability to work independently and collaboratively in a team environment.

Experience:

• Experience working in laboratory or manufacturing environments.
• Experience performing analytical testing and laboratory procedures.
• Experience preparing solutions, reagents, or chemical formulations.
• Experience maintaining laboratory equipment and documentation.
• Experience following quality systems and compliance requirements.
• Experience with data entry and laboratory record management.
• Experience working in regulated environments is preferred.

Responsibilities:

• Adhere to laboratory safety procedures and established safety regulations.
• Read, understand, and follow Standard Operating Procedures (SOPs).
• Perform daily, weekly, monthly, and annual maintenance of laboratory equipment and maintain maintenance logs.
• Manufacture products according to batch records and SOPs in compliance with GMP and quality system requirements.
• Prepare antibody solutions, drug positive solutions, enzyme-conjugate solutions, EIA calibrators, controls, and reagents.
• Perform analytical EIA in-process testing and document results.
• Conduct daily temperature monitoring and maintain related records.
• Support manufacturing goals through production and laboratory activities.
• Participate in Lean and continuous improvement initiatives.
• Operate laboratory equipment safely and effectively.
• Maintain accurate laboratory records, notebooks, and documentation.
• Perform data entry into planning and materials management systems.
• Report testing and production results to supervisors.
• Maintain a clean, organized, and compliant work environment.
• Verify materials are properly labeled, approved, and available for production activities.
• Recommend and participate in revisions to documentation, BOMs, process descriptions, NCMRs, and deviation records.
• Perform formulations, material evaluations, equipment calibrations, and maintenance activities.
• Support overtime and weekend operations as business needs require.
• Ensure compliance with quality requirements and identify potential product or process defects.
• Build productive working relationships with internal and external stakeholders.
• Perform duties in compliance with company policies, procedures, and quality standards.
• Complete additional responsibilities as assigned.

Should Have:

• Knowledge of laboratory instrumentation and equipment operation.
• Experience with immunoassay or EIA testing techniques.
• Problem-solving and troubleshooting abilities.
• Experience in regulated manufacturing or medical device environments.
• Understanding of Lean manufacturing principles and continuous improvement practices.

Skills:

• Laboratory testing.
• Analytical chemistry.
• GMP compliance.
• SOP adherence.
• EIA testing.
• Solution and reagent preparation.
• Equipment calibration and maintenance.
• Documentation and record keeping.
• Data entry and reporting.
• Quality systems.
• Troubleshooting.
• Process improvement.
• Microsoft Office.
• Manufacturing systems.
• Attention to detail.
• Team collaboration.
• Time management.
• Problem-solving.

Qualification And Education:

• Bachelor of Arts (BA) or Bachelor of Science (BS) in Chemistry, Biological Sciences, or a related field required.
• 1 2 years of laboratory experience preferred.
• Experience in GMP-regulated laboratory or manufacturing environments preferred.