Overview
Quality Assurance Analyst – Safety Emphasis Jobs in Lawton, OK at Leidos
Job Description
Quality Control Associate (IVD Medical Device, Immunoassay Manufacturing)
Biomerica Inc, Irvine, CA, USA
Description
NASDAQ publicly traded In Vitro Diagnostic (IVD) medical device company seeks an outstanding Quality Control Associate. Support manufacturing process control to ensure compliance with national and international quality management system requirements. Continuously monitor incoming raw materials, components, and finished products in conformance with CE, ISO-13485, FDA’s QSR/cGMP requirements, and any other applicable regional IVD regulations for product or service to meet the established standards of quality including reliability, usability and performance. The Quality Control Associate entry level position will report directly to the Quality Control Manager.
Essential Duties and Responsibilities
Support the implementation of, and performs QC ELISA assay and Rapid Tests according to established Quality Control Procedures (QCPs) for testing and releasing incoming raw materials, components, and finish products.
Completes records for test results accurately and meticulously on Quality Control Specification Reports and Certificate of Analysis.
Ensures timely completion of Stability testing tasks and meet tight deadlines to support on-going annual testing and shipping studies of products.
Environmental monitoring and trending of facility work area
Receiving and logging retention samples from manufacturing.
Assists in any calibration and maintenance needed for equipment.
Collecting water samples for testing and send to approved contracted lab.
Maintaining and cleaning QC lab, lab-wares and equipment.
Approve non-critical incoming materials after confirming specification.
Collecting and scheduling pick up for biohazard waste.
Ordering Lab supplies.
Monitoring and maintaining log for QC sample panels.
Performs other duties assigned by Supervisor of Quality Control to support the organization and manufacturing departments for process control.
Qualifications and Requirements
BS/BA degree in science discipline (Biology, Biochemistry, Microbiology, Chemistry, etc.)
1 year of lab or diagnostic manufacturer environment experience. Newly graduates are welcome to apply.
Ability to test ELISA or equivalent combination of education and experience.
Job Type: Full-time
Pay: From $23.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
Dental insurance
Flexible schedule
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Experience:
Lab work: 1 year (Required)
Shift availability:
Day Shift (Preferred)
Work Location: In person
Title: Quality Assurance Analyst – Safety Emphasis
Company: Leidos
Location: Lawton, OK
