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QC Support Analyst 2 - 1st Shift

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Location: Durham, United States
Position Type: Unfixed Term
Job Function: Quality

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

 

Position Summary:

Provide laboratory support for execution and process of routine tests for raw materials, intermediates, environmental samples, finished goods, or stability samples submitted to the laboratory. Participate in and support projects that enhance quality support in key department processes.

 

Responsibilities:

  • Responsible for receipt of samples submitted for testing in the laboratory.
  • May support routine testing as assigned by management. Documents all test results in compliance with procedures and GDP requirements.
  • May assist with LIMS data entry to support product testing, LIMS maintenance and validation activities as assigned by management.
  • Participate in and support of the stability program.
  • Participate in and support with improvement projects.
  • Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
  • Maintains personal training file.
  • Assist with maintaining laboratory scheduling for raw materials, intermediates, environmental samples, finished goods, and stability samples.
  • Assist in the stocking of laboratory supplies.
  • Perform any additional job related duties as requested

 

Supplemental Information:

This position is in a fast-paced, FDA regulated environment in the Medical Device/Diagnostics Industry. The QC Support Analyst 2 is in a key position providing support on different projects defined by the QC department. The projects can be related to: microbiology laboratory, biochemistry laboratory, environmental monitoring, LIMS system, stability process program and/or document control.

 

Studies and Experience:

  • BS with 2 years of relevant experience preferred.
  • High school diploma/GED with a minimum of ≥ 6 years of progressively responsible experience or an Associate’s Degree with a minimum of ≥ 4 years of progressively responsible experience working in a regulated, GMP environment required.
  • Industrial experience preferred
  • Experience and scientific knowledge working with relevant microbiology laboratory techniques and quality principles (GMP/GLP).
  • Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.

 

Skills and Qualifications:

  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
  • Excellent and effective verbal and written communication skills.
  • Theoretical knowledge of relevant laboratory techniques and quality principles.
  • Knowledge of software tools for data entry and analysis.
  • Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
  • Ability to assess safety and environmental risks to ensure tasks adhere to HSE Management System
  • Teamwork orientation. 
  • Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
  • Ability to wear PPE correctly most of the day.

 

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 [email protected].

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 [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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