QC Analyst 2 - Night Shift

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

Benefits offered by this job

Medical, dental, and vision plans

Telemedicine options

Life and Accidental Death Insurance

Disability insurance

Retirement plan with employer match

Job summary

bioMérieux in North Carolina is seeking a Quality Control Biochemistry Analyst 2 to perform routine Biochemistry testing and ensure product safety and efficacy prior to release. The role involves testing raw materials, intermediates, and finished products, training staff, troubleshooting equipment, and maintaining documentation in accordance with SOPs, GLP, GMP and GDP.

Candidates typically have a High School diploma with 4+ years of related biochemistry lab experience; a Bachelor's degree is

Qualifications

• 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.
• Bachelor's degree in Chemistry, Biochemistry, or Biomedical preferred.
• Experience with LIMS and data entry/analysis.
• Experience participating in regulatory audits (FDA, ISO, OSHA, etc.).
• Knowledge of ISO/QSR/Quality principles.

Responsibilities

• Train QC testing and instrument maintenance.
• Troubleshoot Biochemistry lab equipment.
• Ensure testing documentation is accurate and compliant with GDP.
• Review laboratory testing per SOPs and complete timely.
• Maintain SOP, GLP, GMP, and HSE compliance.
• Prepare for regulatory audits and support investigations.
• Enter data into LIMS and support validation activities.
• Assist with revisions to QC SOPs as directed.
• Maintain personal training on processes.
• Use PPE as required.
• Support improvement initiatives.
• Collaborate with other departments on validation protocols.

Skills

Written Communications

MS Office

Verbal Communication

Problem Solving

Education

High School Diploma

Bachelor's degree in Chemistry/Biochemistry

Tools

LIMS

Excel

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.

Primary Duties

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.