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Qc Analyst Ii, Microbiology

3 months ago

Boston, United States Integra LifeSciences Full time

Changing lives. Building Careers.

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Quality Control Analyst II, Microbiology, will be responsible for performing quality control microbiological 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- Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Gram staining, Growth promotion testing, sending samples to Microbial ID testing and other micro testing.- Perform Environmental monitoring of clean rooms including Viables and Non-viables testing and responsible of collecting and performing water samples.- Working knowledge of aseptic techniques and provides database support, generates reports, and analyzes the data as needed.- Inspection and testing of raw materials, in-process, and final product testing.- Assist in trending environmental monitoring data, Report and investigate any monitoring excursions.- Monitors equipment and instrumentation used daily to ensure proper operation and calibration.- Maintains a working inventory of all components and archived materials and solutions as needed.- Assists in the writing and updating of Microbiological test procedures, protocol, logbooks, and checklists.- Develops and revises SOPs and trains appropriate new hires.- 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.- Assist as needed in test method validation, investigation studies or other product development studies.- 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

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.- Bachelor’s degree in microbiology, Biology, or a relevant scientific discipline.- A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.-
- Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.- Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques.- 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.

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.

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