The Quality Control Technician will be responsible for performing quality inspections and testing according to established procedures.
Inspection and testing activities will cover incoming, work-in-process, and finished goods. Selects random samples for tests at specified stages such as incoming or in production process, and tests products for variety of qualities, such as dimensions, performance, appearance, correct assembly, and other testing outputs.
Records test data, applying statistical quality control procedures.
Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities.
Consults with management to resolve quality, production, and efficiency problems.
Functions in conjunction with manager and functional experts on special department projects.
Performs the essential duties and responsibilities as listed in section below.
Essential Duties And Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
Perform chemical assay of solutions as well as general laboratory maintenance
Inspection and testing of raw materials, intermediates and final product
Environmental monitoring of clean rooms and water system
Maintains a working inventory of all components and archived materials and solutions
Assist as needed in test method validation, implementation, and execution
Provides database support, generate reports and analyze process data
Assist in Out of Specification (OOS) and non-conformance (NC) investigations
Assist in preparing for and participating in FDA audits, customer audits, etc.
Demonstrate excellent organizational and time management skills
Perform other duties as required
Desired Minimum Qualifications
Education: An Associate s Degree in the biological or chemical sciences or equivalent with related work experience is required.
Experience: A minimum of 0 1-year experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated product preferred environment.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action. Detail-oriented.
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