Associate Manager, Final QC Laboratory

2 Months ago • 3 Years + • Quality Assurance

Job Summary

Job Description

Manage the personnel, material resources, and operations of the Final Quality Control Reagent Laboratory. Responsible for ensuring departmental compliance with all regulations, quality systems, and customer requirements. Develop, implement, and monitor laboratory processes, metrics, personnel, and testing methods to ensure reagent conformance. Provide coaching, feedback, guidance, and training to employees. Develop and maintain quality performance metrics for the laboratory, oversee performance testing, and assist technicians in prioritizing tasks. Implement departmental operational procedures for regulatory compliance (FDA, GMP, ISO, CLIA, OSHA). Make recommendations for improving quality and productivity, offer troubleshooting expertise, and lead efforts for continuous product and process improvement. Ensure the quality of finished goods and materials, oversee QC testing, and support environmental monitoring.
Must have:
  • Bachelor's degree in a scientific or technical field
  • 3+ years of experience in a laboratory or quality inspection area
  • Excellent verbal and written communication skills
  • Advanced knowledge of QC systems, practices, and procedures
  • Strong computer skills including Microsoft Office Suite
  • Strong knowledge of GMP, ISO, and FDA compliance
Good to have:
  • 1+ year supervisory experience
  • Ability to lead others, provide coaching, and delegate assignments
  • Technical writing skills
  • Knowledge of VITEK2 cards and instrument operation

Job Details

Description

Position Summary & Responsibilities:
Manage the personnel, material resources, and operations of the Final Quality Control Reagent Laboratory.  Responsible for ensuring departmental compliance with all regulations, quality systems, internal and external customer requirements.   Develop, implement, and monitor the performance of Final Quality laboratory processes, metrics, personnel, and testing methods to ensure reagents conformance.  Provide coaching, feedback, guidance, and training to employees, ensuring an engaged and skilled staff.

  • Develop and maintain quality performance metrics for the laboratory to provide management a method of assessing defect patterns/trending and associated lot set-up issues.
  • Oversees the performance testing functions, ensuring efficiency to meet production demands and continuous improvement of laboratory performance.  As applicable, oversee the physical inspection of production cards, cartons, and pouches.
  • Assists Lab Technicians in prioritizing to ensure schedule is met.
  • Develop and implement departmental operational procedures to ensure regulatory compliance within the laboratory (FDA, GMP, ISO, CLIA, OSHA, etc.).
  • Make recommendations for improving quality & productivity performance, offer troubleshooting expertise, and conduct quality improvement studies where appropriate.
  • Lead efforts to ensure continuous product and process improvement in areas of responsibility.
  • Ensure the quality of finished goods and materials to maximize the utilization of resources to meet goals.  Ensure timeliness and efficiency of goods and material testing.
  • Oversee and monitor QC testing that is part of the site instrument release program.
  • Support and collaborate on environmental monitoring with the QC Micro team.
  • Works with other departments to ensure operational and quality goals are understood and met.  
  • Provide methods to communicate the quality status of materials and processes to internal customers, management, and external suppliers.
  • Monitor and maintain departmental personnel meet commitments / deadlines.  Lead team members by establishing performance criteria, providing training and resources, giving regular coaching, feedback, and guidance. Ensures an engaged and skilled workforce through active listening and communication.
  • Collaborate with the QC Micro group, Quality on Floor, and Quality Release team.
  • Support QC and other projects and participates on special teams as requested by management.
  • Performs testing and physical inspections per product procedure, as needed

Education, Skills, & Experience:

  • Bachelor's degree required, in a scientific or technical field preferred, with 3+ years of progressively responsible experience in a laboratory or quality inspection area, performing varied testing and troubleshooting activities in high volume environment.
  • 1+ year supervisory experience is highly preferred.  
    • At a minimum, must demonstrate the ability to lead others by building relationships, provide coaching and feedback to employees, and delegate assignments as needed to ensure efficient work production. 
  • Proven excellent verbal and written communication skills are a must as this position interacts at all levels of the organization and acts as immediate back-up to the Sr. QC Manager as needed
  • Requires advanced knowledge of QC systems, practices, and procedures including microbiological, testing, and inspection processes.
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). 
  • Must have a strong knowledge of GMP, ISO, and FDA compliance
  • Technical writing skills preferred
  • Knowledge of VITEK2 cards and instrument operation and troubleshooting preferred

#LI-US

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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