Quality Control Technician II, Analytical

Integra LifeSciences Corporation; Boston (MA); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Control Technician II to join their team in Boston. This role is pivotal in ensuring the quality and compliance of products through rigorous analytical testing and adherence to FDA and ISO regulations. The successful candidate will perform a variety of tests, maintain equipment, and assist in audits, contributing to the advancement of healthcare solutions. If you are passionate about quality assurance and eager to make a difference in the medical field, this opportunity is for you. Join a forward-thinking company dedicated to innovation and excellence in patient care.

Qualifications

• 2-4 years experience in medical device or pharmaceuticals preferred.
• Familiarity with FDA and ISO quality standards required.

Responsibilities

• Perform Analytical testing such as TOC, Conductivity, Osmometry, and pH.
• Assist in writing and updating analytical test procedures and protocols.

Skills

Analytical Testing

Problem Solving

Attention to Detail

Quality Compliance

Data Analysis

Communication Skills

Education

Bachelor’s Degree in Biological or Chemical Sciences

Tools

Microsoft Office

Instron

Differential Scanning Calorimeter (DSC)

Burst Testing Equipment (DBT)

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 what’s 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 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.

RESPONSIBILITIES

1. Responsible for performing Analytical testing such as TOC, Conductivity, Osmometry and pH testing.
2. Perform mechanical testing, DSC (Differential scanning calorimeter) and DBT (Burst testing).
3. Inspection and testing of raw materials, in-process, and final product testing.
4. Monitors equipment and instrumentation used daily to ensure proper operation and calibration.
5. Assists in the writing and updating of analytical test procedures, protocol, logbooks, and checklists.
6. 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.
7. Develops and revises SOPs and trains appropriate new hires.
8. Maintains a working inventory of all components and archived materials and solutions as needed.
9. Assist as needed in test method validation, investigation studies or other product development studies.
10. Provides database support, generates reports, and analyzes the data as needed.
11. Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
12. Assist in preparing for and participating in FDA audits, customer audits, etc.
13. All other duties as assigned.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

1. Bachelor’s Degree in the biological or chemical sciences or equivalent with related work experience is required.
2. A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.
3. Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.
4. Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
5. Experience with performing Instron, DSC and DBT testing preferred. Working knowledge of standard laboratory practices and safety.
6. Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
7. Experience working in ISO Class 7 cleanrooms preferred.
8. Working knowledge and understanding of instruments including pH, Conductivity, Total Organic Carbon Water, Osmometry, Instron, Differential Scanning Calorimeter, Identification of Raw Materials, and the visual inspection of raw material in-process and final product samples.