Position Summary & Responsibilities:
This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The Quality Control Testing Inspector II will be in a key position in the Quality Control department by facilitating sample and material inspection, result review and communication, and testing continuity. Perform routine inspection on material received and samples submitted to Quality Control laboratories, and verify the results and communication of testing.
- Quality
- Ensures all inspection and documentation is completed in an accurate, thorough, and timely manner.
- Ensures review of Quality Control documentation is done in compliance with SOPs and is completed in an accurate and timely manner.
- Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
- Prepares for regulatory, customer, and internal audits of Quality Control areas.
- Preparation includes review of logbooks, material expirations, component storage, etc.
- Provides input for laboratory investigations.
- Documentation/Training
- Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
- Ensures personal training is maintained to current department processes and procedures.
- Safety
- Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine duties.
- Continuous Improvement
- Participate in continuous improvement activities.
- 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
- Other Duties
- Performs additional job-related duties as assigned by management.
Education, Skills, & Experience:
- High School Diploma with 2+ years of experience working in a laboratory or regulated environment, GMP preferred
- Bachelor's degree with 0 years of relevant experience also accepted. Degree in a Life Science field preferred.
- Prior laboratory experience preferred.
- Experience with GMP documentation preferred.
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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at recruitment@biomerieux.com, or by dialing 711 for access to Telecommunications Relay Services (TRS).