QC Analyst 2 - Night Shift

bioMérieux; Durham (NC); On-site; USD 68,770,000 - 104,014,000; Full time

Benefits offered by this job

Medical (Rx) plans

Dental & Vision

Retirement Plan

Disability Insurance

Wellness Programs

Employee Assistance Program

Commuter Benefits

Parental leaves

Job summary

bioMérieux in Durham, North Carolina seeks a QC Analyst 2 to perform routine Biochemistry testing of raw materials, intermediates, finished products, and stability samples. This 3rd shift role runs Monday–Friday from 11:00 pm to 7:30 am and requires adherence to established acceptance criteria prior to product release.

The role includes training of QC testing staff, instrument troubleshooting, and meticulous documentation in LIMS and SOPs, with emphasis on GMP/GLP, GDP, and regulatory readiness.

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 highly preferred in Chemistry, Biochemistry, or Biomedical.

Responsibilities

• 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 LIMS and paper-based data sheets as applicable.
• Assists with revisions to QC SOPs as directed by management.

Skills

Written communications

MS Office

Problem solving

SOP compliance

QC testing

Documentation

Education

High School Diploma

Bachelor’s degree (preferred)

Tools

LIMS

Excel

Job description

Position Summary – QC Analyst 2

This is a 3rd shift role working Monday - Friday from 11:00 pm - 7:30 am.

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.

Description

Position Summary – QC Analyst 2

This is a 3rd shift role working Monday - Friday from 11:00 pm - 7:30 am.

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.

Education

• High School Diploma, GED or equivalent
• Education substitution option: N/A
• Bachelor’s degree highly preferred in Chemistry, Biochemistry, or Biomedical

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%
• International 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.

Benefits

• 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

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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 [phone], by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).