bioMerieux

Description

Position Summary:

The Quality Assurance (QA) department provides Quality support across various company departments. The department is organized into distinct subunits, consisting of Metrology, Document Control, Reagent Quality, Instrument Quality, Servicing Quality, and Incoming Material QC.

This is an entry-level position. Depending on the sub-unit, this individual may review quality records, inspect manufactured products and raw materials, perform calibration and preventive maintenance on tools and equipment, and/or maintain Quality system documents. Timely and accurate work is expected. This position regularly interacts and collaborates with other departments within the company.

Primary Duties:

1. Perform all work in compliance with company policy and within the guidelines of its Quality System.
2. Responsible for reviewing, assessing and monitoring process and product to ensure compliance to requirements.
3. May contribute to other Quality Assurance subunits that are outside of their primary Quality Assurance subunit, as assigned.
4. Perform inspection of incoming materials using basic and advanced measurement tools
5. Perform quarantine activities including physical and electronic segregation, labeling, physical and electronic release
6. Perform second person verifications
7. Initiate NCRs with a thorough description of the nonconformance including target as well as discrepancy, quantity and standard used for rejection
8. Perform rework activities to completion
9. Identify need for WID updates
10. Support validation testing, e.g. GR&R and program validations
11. Comparison of defined aspects of physical materials to written specifications to determine compliance.
12. Determine suitability of manufactured materials for release to manufacturing.
13. Determine compliance of equipment with calibration requirements.

Supplemental Data:

Minimal domestic travel may be required for training purposes

Training, Education and Experience:

1. High school diploma or equivalent is required.
2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and/or 21 CFR 820 is required.
3. Minimum 1-year previous on-the-job experience requiring professional communication and interactions utilizing skills outlined below.
4. Minimum 1-year previous on-the-job experience in a Quality Inspection position using simple and advanced metrology tools.
5. Experience in a Quality Assurance, Quality Control, laboratory or life science or other manufacturing setting that has a formal quality system is preferred.

Knowledge, Skills and Abilities:

1. Effective written and verbal communication skills.
2. Proficiency in MS Office tools, including Outlook, Word, and Excel.
3. General computer operation.
4. Attention to detail is fundamental to this position.
5. Ability to accurately follow written and verbal instructions.
6. Organization skills as needed to maintain paperwork and task schedule.
7. Proficiency in internet navigation.
8. Basic math proficiency.

Physical Requirements:

1. Must be able to lift at least 25 lbs and may be required to lift up to 50 lbs.
2. Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation. Must be able to travel (if necessary).
3. Must be able to wear PPE correctly for most of the day.
4. Must be able to distinguish colors.

1. Enter data into the CAL/PM software 2. Scan calibration certificates into the Cal/PM software 3. Perform Level 1 Calibrations (Pipette, Pressure, Calipers) 4. Perform second person verification of calibration 5. Escort suppliers into restricted areas to perform on-site calibration 6. Review and approve calibration and preventative maintenance forms 7. Perform contamination swabbing 8. Schedule vendor calibrations 9. Create NCR's for out of calibration events 10. Respond to "out of tolerance" events 11. Respond to temperature monitoring alarms 12. Alert manager of equipment outside of its calibrated state 13. Alert manager of incomplete and inaccurate documents 14. Review and determine compliance of equipment within calibration requirements. 15. Review quality documents for completeness and accuracy

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).