Amber Bloss-Annis
Granger,IN
Summary
Experienced Senior Chemist and Laboratory Manager with great team leadership skills. Demonstrated success in Medical Device product management. Experienced Supply Chain and Logistics Manager. Independently formulates medical diagnostic liquid reagents. Sound judgment, strong work ethic and upholds integrity standards. Specializing in Medical Device and Pharmaceutical industry.
Overview
27
27
years of professional experience
Work History
Biochemist
Siemens Healthineers
Elkhart, In
10.2024 - Current
- Quality control testing of antibodies and antigens for IVDD Medical Devices
- Conducted biochemical analysis to support diagnostic product development.
- Evaluated experimental data to refine research methodologies effectively.
- Monitored inventory levels of reagents, chemicals, and supplies used in the lab.
- Analyzed data from biochemical experiments to identify patterns and correlations.
- Test procedure review.
- Participated in Lean projects.
- HPS Structured Problem Solving Level II Practitioner certification.
- Internal auditing.
Liquid Chemistry Supervisor
EKF Life Sciences
Elkhart, Indiana
11.2010 - 07.2024
- Manage Liquid Chemistry department and formulate medical diagnostic reagents from raw materials to finished Medical Device
- Set production schedule according to customer’s annual forecast
- Work with critical suppliers to produce custom materials for medical devices. Order, receive, release materials, and maintain inventory par levels
- Perform assays and analyze data
- Maintain excellent communication with domestic and international customers
- Shipping and Receiving Manager
- Member of company’s safety committee
Manager
Octapharma Plasma Center
08.2009 - 11.2010
- Manage over 50 employees.
- Proficient in all departments including being certified as a medical screener, laboratory plasma processing technician and phlebotomist to perform plasmapheresis.
- Passing regulated audits including CLIA/COLA, IQPP, FDA, and EU.
- Order, receive, release and maintain inventory par levels for medical supplies.
- Operating under strict guidelines and SOP's regulated by the FDA.
- Utilize cGMP/ISO requirements.
Pharmacy Technician
Elkhart General Hospital
05.1999 - 08.2009
- Pharmaceutical compounding including antibiotics, syringes, irrigations, epidurals, and immunoglobulins, etc.
- Enter physician orders and fill prescriptions
- Work in the open-heart/critical and surgery satellite pharmacies
- Maintaining sufficient quantities of medications and gases for anesthesiologists
- Use medical coding to document patient’s medications and dosages used during surgery
- Utilizing ResQ, STAR, EGOR, and McKesson software systems
- Worked on 5S and lean teams
Education
B.S. - Bio-Medical Science and Chemistry
Western Michigan University
Kalamazoo, MISkills
- 14 years Medical Device liquid reagent manufacturing and managing experience
- 14 years Supply Chain, Logistics, and Inventory management experience
- Experience in Process Improvement, Product & Project management
- 10 years pharmaceutical compounding experience
- SME for Medical Device reagents
- FDA, ISO, CLIA/COLA, EU, and medical device customer audit experience
- Logistics representative for current employer
- IATA DGR 63rd Certified
- 5S and lean manufacturing experience
- Determined and driven when completing tasks
- Excellent communication skills
Timeline
Biochemist
Siemens Healthineers
10.2024 - Current
Liquid Chemistry Supervisor
EKF Life Sciences
11.2010 - 07.2024
Manager
Octapharma Plasma Center
08.2009 - 11.2010
Pharmacy Technician
Elkhart General Hospital
05.1999 - 08.2009
B.S. - Bio-Medical Science and Chemistry
Western Michigan University