QC Testing Inspector II

2 Days ago • 2 Years +

Job Summary

Job Description

This position in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry involves sample and material inspection, result review and communication, and testing continuity. The Quality Control Testing Inspector II will perform routine inspection on material received and samples submitted to Quality Control laboratories, verify the results and communication of testing. Ensuring accurate, thorough, and timely inspection and documentation, reviewing Quality Control documentation in compliance with SOPs, and maintaining compliance with SOPs, GLP, GMP, and HSE requirements are key responsibilities. Additionally, the role includes preparing for audits, providing input for laboratory investigations, and entering data into the LIMS and applicable data sheets.
Must have:
  • Ensures accurate and timely inspection and documentation
  • Reviews QC documentation per SOPs
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements
  • Enters data into LIMS
  • Maintains training on procedures
Good to have:
  • Prior laboratory experience
  • Experience with GMP documentation

Job Details

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.
 

Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at recruitment@biomerieux.com.

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).

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