Quality Control Technician II, Analytical

Integra LifeSciences Holdings Corp.-posted about 2 months ago
$26 - $35/Yr
Full-time • Mid Level
Braintree, MA
1,001-5,000 employees
Miscellaneous Manufacturing
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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 what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. ESSENTIAL DUTIES AND RESPONSIBILITIES: The Quality Control Technician II will be responsible for performing quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and procedures purchased components, manufactured sub-assemblies 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.

  • 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, in-process, 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, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
  • Assist in preparing for and participating in FDA audits, customer audits, etc.
  • All other duties as assigned.
  • Bachelor's Degree in the biological or chemical sciences or equivalent with related work experience is required.
  • A minimum of 2-4 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.
  • 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.
  • Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.
  • Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
  • Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/
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