Quality Control Technician II Analytical
Quality Control Technician II Analytical
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Job Description
Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day our colleagues are challenging whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
SUMMARY
The Quality Control Technician II will be responsible for performing Quality Control Analytical laboratory testing of inprocess finished goods validation studies and adherence to all applicable regulations policies and procedures purchased components manufactured subassemblies and final product. Must have working knowledge of U.S. Food and Drug Administration regulations ISO 13485 and other applicable regulatory agencies as they pertain to laboratory testing.
RESPONSIBILITIES
Responsible for performing Analytical testing such as TOC Conductivity Osmometry and pH testing.
Perform mechanical testing DSC (Differential scanning calorimeter) and DBT (Burst testing).
Inspection and testing of raw materials inprocess and final product testing.
Monitors equipment and instrumentation used daily to ensure proper operation and calibration.
Assists in the writing and updating of analytical test procedures protocol logbooks and checklists.
Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.
Develops and revises SOPs and trains appropriate new hires.
Maintains a working inventory of all components and archived materials and solutions as needed.
Assist as needed in test method validation investigation studies or other product development studies.
Provides database support generates reports and analyzes the data as needed.
Assist in Out of Specification (OOS) Investigations Nonconformances and Corrective Action/Preventive Actions (CAPAs).
Assist in preparing for and participating in FDA audits customer audits etc.
All other duties as assigned.
QUALIFICATIONS
The requirements listed below are representative of the knowledge skill and/or ability required for this position.
Bachelors Degree in the biological or chemical sciences or equivalent with related work experience is required.
A minimum of 24 years experience in a medical device pharmaceuticals Quality/Regulatory Compliance or other cGMP regulated product preferred environment.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g. CQE CQA Six Sigma) preferred.
Proficient computer competence including experience with database and Microsoft Office software to create reports spreadsheets analyze data and prepare presentations.
Experience with performing Instron DSC and DBT testing preferred. Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely recognize deviations and recommend corrective action.
Experience working in ISO Class 7 cleanrooms preferred.
Experience with Microsoft Office software to create reports spreadsheets analyze data and prepare presentations.
Working knowledge and understanding of instruments including pH Conductivity Total Organic Carbon Water Osmometry Instron Deferential Scanning Calorimeter Identification of Raw Materials and the visual inspection of raw material inprocess and final product samples.
Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If youd like more information on your rights under the law please see the following notices:
EEO Is the Law EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation please email us at or call us at.
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Required Experience:
IC
Employment Type
Full-Time
