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SUMMARY
The Microbiology Technician II will be responsible for performing environmental monitoring, 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
RESPONSIBILITIES
Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Gram staining, Growth promotion testing, TOC & Conductivity testing, sending samples for Microbial ID testing and other micro testing.
Perform Environmental monitoring of clean rooms including Viables and Non-viables testing and responsible of water samples collection and testing.
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, materials and solutions as needed.
Develops and revises SOPs & Forms.
Training of new hires.
Responsible for identifying and alerting supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.
Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
Assists in the writing and updating of Microbiological test procedures, protocol, logbooks, and checklists.
Assist as needed in test method validation, investigation studies or other product development studies.
Assist in preparing for and participating in FDA audits, customer audits, etc.
All other duties as assigned
DESIRED MINIMUM 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.
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 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 & 8 cleanrooms preferred.
Salary Pay Range:
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
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 Total Rewards | Integra LifeSciences
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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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 careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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