QC Analyst 2 - Night Shift

bioMerieux; Cary (NC); On-site; USD 33,000 - 50,000; Full time

Benefits offered by this job

Medical, dental, vision plans

Life Insurance

Disability Insurance

Retirement Plan

Job summary

bioMérieux is seeking a QC Biochemistry Analyst 2 for night shifts in North Carolina. The role involves routine testing of raw materials, intermediates, and finished products, with responsibilities including data entry in LIMS, ensuring GDP-compliant documentation, and supporting investigations and audits.

The candidate will train others and maintain equipment as needed. The position requires 4+ years in a regulated Biochemistry/Chemistry lab, with a preference for a Bachelor's in

Qualifications

• High School Diploma or equivalent required.
• 4+ years in a regulated Biochemistry or Chemistry lab with GxP testing.
• Experience with data entry and analysis using laboratory software (LIMS) is preferred.

Responsibilities

• Participates as a trainer for Quality Control testing and instrument maintenance.
• Troubleshoots basic Biochemistry lab equipment issues.
• Ensures documentation and test results are accurate and timely per SOPs and GDP.
• Maintains compliance with SOPs, GLP, GMP and HSE requirements.
• Prepares for regulatory audits and supports investigations as needed.

Skills

Written communication

Verbal communication

MS Office

Technical writing

Problem solving

Quality documentation

Education

High School Diploma or equivalent

Bachelor’s degree in Chemistry/Biochemistry (preferred)

Tools

LIMS

Job description

The normal working hours for this role is NIGHT SHIFT 7:00pm - 7:30am working a 2-2-3 rotation schedule.

Generic Summary

Quality Control is responsible for testing and confirming product safety and efficacy through laboratory. Execute, raw material, intermediate products, final product and stability testing as defined to ensure product meets the established acceptance criteria prior to the product's release for commercial sale.

Local Specific Summary

“The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing.

The responsibilities of this position include:

• Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.
• Investigational writing of INVALID reports.
• Provide input and support for Out of Specification reports.
• Serve as a certified trainer for laboratory testing as applicable.

Local Primary Duties

• Participates as a trainer for Quality Control testing and instrument maintenance.
• Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.
• Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
• Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
• Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
• Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
• Executes laboratory investigations as assigned by management in compliance with procedures.
• Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
• 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.
• Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.
• Ensures personal training is maintained to current department processes and procedures.
• Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
• Participate in improvement initiatives as directed by management.
• Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Education, Training, and Experience

• High School Diploma, GED or equivalent
• 4+ years of related experience – Experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing

Preferred Education, Training, and Experience

• Bachelor's degree highly preferred in Chemistry, Biochemistry, or Biomedical
• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
• Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods.
• Ability to wear PPE correctly most of the day.
• No ability required for ascending/descending stairs, ladders, ramps, etc.
• No ability required to operate heavy machinery.
• No requirement to adjust or move objects up to 50 pounds in all directions.
• Domestic travel required: 0%

Key Skills (from KSAs)

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Written Communications – including the ability to communicate technical data in written form
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel – Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance
• Excellent and effective verbal and written communication skills.
• Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.

The estimated salary range for this role in the state of North Carolina is between $24 and $36.30/hr. 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.

• 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.