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IFA Controls Chemist
2 months ago
Location: United States
Shift: 1st
Company Overview: Werfen is a global leader in the development, manufacturing, and distribution of specialized diagnostic instruments and related solutions. Established in 1966, our focus is on providing advanced diagnostic tools primarily for hospitals and independent clinical laboratories. Our product lines encompass Hemostasis, Acute Care, and Autoimmunity diagnostics, alongside Original Equipment Manufacturing. Our commitment to innovation and quality drives our success in these dynamic diagnostic fields.
Position Summary: The IFA Controls Chemist plays a crucial role in the preparation of autoimmune diagnostic Immunofluorescence Assay (IFA) slides, controls, and conjugate products, adhering to established protocols. Key responsibilities include:
- Assisting in the manufacturing processes of IFA control and conjugate products, following detailed instructions and schedules.
- Supporting the maintenance and cultivation of insect cells and harvesting cloned antigens as per established guidelines.
- Conducting tests on IFA slide products to ensure acceptable titer and pattern reactivity in accordance with manufacturing documents.
- Evaluating raw materials, in-process materials, and finished reagents related to IFA products.
- Maintaining comprehensive Device History Records and laboratory notebooks, ensuring compliance with current Quality Systems Regulations (QSRs).
- Preparing, calibrating, operating, and cleaning equipment used in the production of IFA slide products according to Standard Operating Procedures (SOPs).
- Assisting in experimental activities related to process validation and nonconformance investigations as directed by supervisors.
- Communicating equipment needs and supply requirements to prevent production interruptions.
- Maintaining a clean and organized work area, adhering to safety and environmental protocols.
Qualifications:
Candidates should possess a Bachelor’s degree in biological, chemical, or related sciences, along with 0-2 years of relevant laboratory experience. A solid understanding of biological and chemical laboratory procedures, basic laboratory equipment operation, and knowledge of FDA and ISO regulations is essential. Proficiency in Microsoft Word and Excel is also required.
Compensation: The salary range for this position is $23/hr - $29/hr, commensurate with experience and qualifications.
Werfen is an Equal Opportunity employer, dedicated to fostering a diverse workplace and strictly prohibits discrimination based on any protected characteristic.
