DESCRIPTION

The QC System Support Specialist will be responsible for the deployment, management, and support of Laboratory Information Management Systems (LIMS). They are responsible for various tasks within the LIMS application lifecycle (commissioning, validation, administration, decommissioning). They also provide technical leadership in configuring, customizing, and deploying LIMS implementation and enhancements.

Primary Duties:

• Participates and provides appropriate team support in cross-function activities (e.g., method transfers, method validations, and cross-functional projects)
• Utilize and troubleshoot LIMS (LabVantage); participate and/or led LIMS (Labvantage) maintenance and validation activities. Collaborate with the Global LIMS team, IT department, and LIMS (LabVantage) users to ensure new functionality meets user requirements. Leads and write test scripts for new LIMS (Labvantage) functionality and participate in the validation of new functionality releases.
• Support the expansion of the LIMS (Labvantage) platform through the preparation and execution of test cases for system validation. Revise or develop LIMS (Labvantage) functional requirement specifications and user requirement specifications as well as other relevant documentation with guidance.
• Perform and document laboratory testing to evaluate compliance of products to release specifications. Monitor environmental monitoring contamination through daily testing and trending. Coordination and implementation of corrective actions/preventative measures.
• Supports GMP documents including procedure revisions, change requests, failure and complaint investigations, protocols and reports.
• Manage Stability program.
• Displays critical/logical thinking and collaborates across departments in designing and completing continuous improvement projects.
• Supports Internal/External audits, as needed.
• Conducts or supports nonconformance investigations for product/process/facility issues. Reviews and approves non-conformance investigations. Ensures appropriate use of quality management tools (5 Why’s, Pareto Analysis, 5M+E, Is/Is Not, etc.) in determining root cause.
• Conducts or supports CAPA investigations that result from nonconformance investigations, complaint investigations internal quality audits and other relevant functions. Completes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness and root cause analysis.

Minimum Qualifications:

• BS/BA in Engineering, Microbiology, Biology, Chemistry, Biochemistry or scientific field with a minimum of 3 years relevant laboratory technique and quality experience required

• • OR Master degree with 2 years of relevant laboratory technique and quality principles.
• Minimum 2 years’ experience in the use of software tools for data entry and analysis; advanced technical writing skills.
• Minimum 2 years’ experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Technical writing experience preferred

Knowledge, Skills, and Abilities

• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, USP, EP, JP, etc.).
• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
• Excellent and effective verbal and written communication skills.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Good leadership and communication skills; Teamwork orientation.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
• Good knowledge in the interpretation and analysis of QC test results.
• Competence in the selection and use of Quality Testing techniques.
• Excellent and effective written communication and technical writing skills. Clearly demonstrates competence in the selection and use of quality management tools and techniques (5 Whys, Pareto Analysis, 5M +E).
• Displays strong interpersonal skills and ability to work with all levels of an organization. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing tasks.
• Demonstrates the ability to read, understand, author, redline and execute standard operating procedures (SOPs).
• Exhibits both analytical and problem-solving skills

The estimated salary range for this role based in Illinios is between $75,500 – 98,900. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

• A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
• Company-Provided Life and Accidental Death Insurance
• Short and Long-Term Disability Insurance
• Retirement Plan including a generous non-discretionary employer contribution and employer match.
• Adoption Assistance
• Wellness Programs
• Employee Assistance Program
• Commuter Benefits
• Various voluntary benefit offerings
• Discount programs
• Parental leaves

• Participates and provides appropriate team support in cross-function activities (e.g., method transfers, method validations, and cross-functional projects)
• Utilize and troubleshoot LIMS (LabVantage); participate and/or led LIMS (Labvantage) maintenance and validation activities. Collaborate with the Global LIMS team, IT department, and LIMS (LabVantage) users to ensure new functionality meets user requirements. Leads and write test scripts for new LIMS (Labvantage) functionality and participate in the validation of new functionality releases.
• Support the expansion of the LIMS (Labvantage) platform through the preparation and execution of test cases for system validation. Revise or develop LIMS (Labvantage) functional requirement specifications and user requirement specifications as well as other relevant documentation with guidance.
• Perform and document laboratory testing to evaluate compliance of products to release specifications. Monitor environmental monitoring contamination through daily testing and trending. Coordination and implementation of corrective actions/preventative measures.
• Supports GMP documents including procedure revisions, change requests, failure and complaint investigations, protocols and reports.
• Manage Stability program.
• Displays critical/logical thinking and collaborates across departments in designing and completing continuous improvement projects.
• Supports Internal/External audits, as needed.
• Conducts or supports nonconformance investigations for product/process/facility issues. Reviews and approves non-conformance investigations. Ensures appropriate use of quality management tools (5 Why’s, Pareto Analysis, 5M+E, Is/Is Not, etc.) in determining root cause.
• Conducts or supports CAPA investigations that result from nonconformance investigations, complaint investigations internal quality audits and other relevant functions. Completes CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness and root cause analysis