QC002-11
The Quality Control Associate I is responsible for executing Quality Control (QC) processes associated with production, purchased product, reagent stability program, retention program, controlled storage monitoring, and departmental calibration and maintenance.
The Quality Control Associate I also participates in QC processes associated with test method development, product development, equipment and method validations. The position will monitor and prepare laboratory reagents for internal use. The position is also responsible for maintaining QC laboratory supplies as well as maintaining the integrity and cleanliness of QC work areas.
The position entails frequent intra-department interaction as well as frequent inter-department interfaces with Quality Assurance, Reagent Manufacturing, Production Planning, Purchasing, and Document Control.
Responsibilities:
Assist in establishing annual CAPP objectives; fulfill individual CAPP objectives
Log-in incoming samples for testing and retention
Process purchased materials for release
Process intermediate and finished products for release
Complete QC sections of process documentation
Prepare Certificates of Quality
Document non-conformances
Schedule outsource testing and services
Respond to environmental monitoring notifications of specialized storage areas
Coordinate and/or conduct maintenance and calibration of local measuring and monitoring devices
Monitor section supplies, maintain focused supplies and generate Purchase Orders as needed
Prepare laboratory reagents for internal use
Maintain cleanliness and integrity of QC laboratory and storage areas
Participate in applicable departmental and interdepartmental training
Assist in validations of test methods, equipment, and processes
Assist in planning, sample scheduling, sample processing, and conclusion of product stability studies
Assist in compilation of technical deliverables
Assist in investigations initiated through non-conformances, corrective/preventive actions, or customer complaints
Assist in development of assays and test methods
Interface with other departments as required.
Ensure personal compliance with Quality System
Participate in additional quality activities as required
Skills and Experience:
Bachelors of Science degree in a Life Sciences, Chemistry, or Medical Technology field.
And, at least 1 year of experience in quality control or laboratory experience in a Life Sciences, Chemistry or Medical Technology field.
Mathematical aptitude.
Effective oral and written communication skills.
Relevant combinations of education, experience, training, and merit may be considered upon the review of Quality Control Director.
Location: Austin, TX
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