- Performs Autoimmune Immunofluorescent (IFA) Quality Control testing in the department.
- Testing includes Slide substrate testing (HEp-2, MSK and Crithidia slides), component bulks, fills, raw materials and finished kits testing according to FDA/ISO regulated manufacturing and per documented methods employing Good Laboratory Practices.
- Follows and interprets standard procedures.
- Assists in maintaining accurate inventory by reporting usage and reviewing discrepancies.
- Performs labor transactions using manufacturing system software.
- Enters labor into ERP system. Records indirect labor tracking.
- Experienced in the safe handling of chemical and biological hazards.
- Completes batch records and equipment logs following SOPs.
- Initiates deviation reports or non-conformance reports as required.
- Maintains and updates procedures.
- Operates clinical lab equipment, performs preventative maintenance and equipment calibrations and assures quality of output.
- Proficient in all processes.
- Trouble shoots minor equipment problems and production problems following standard procedures.
- Cleans and maintains work area and equipment.
- Our company is a global leader providing a broad array of clinical diagnostics and life science research products.
- With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
- Our company was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
- To all recruitment agencies: Our company does not accept agency resumes, unless the agency has been authorized by a company Staffing Representative.
- Ability to set up, operate and troubleshoot testing equipment.
- Proven Ability to be a team player as well as able to work independently.
- Able to effectively communicate orally and in writing and follow written and verbal instructions.
- High attention to detail. Good visual acuity.
- Able to monitor multiple functions simultaneously.
- Able to understand and comply with a variety of policies of moderate complexity.
- Able to work in a clean room environment with appropriate gowning restrictions.
- Tolerance to varying noise levels. Good manual dexterity, eye and hand coordination.
- Basic math and computer skills are needed.
- Working knowledge computer software such as Microsoft Excel and Word.
- Ability to use manufacturing software for labor transactions and results entry.
- Demonstrated ability to lift up to 25 lbs.
- AA/AS or equivalent combination of education and experience
- Experience: 2-5 years experience in general laboratory or regulated industry or clinical laboratory, or equivalent combination of education and experience to meet the minimum requirements of the job.
- Understanding of Good Manufacturing Practices and Good Lab Practices.
- Microscope experience preferred.