QC Lead Analyst

Quality Control (QC) Biochemistry Lead Analyst providing front-line leadership for the QC Biochemistry team performing routine testing of raw materials, intermediates, finished goods, and stability samples. The role oversees and may execute testing while ensuring regulatory compliance, accurate documentation, and proper use of validated and calibrated instrumentation. Applies advanced analytical and regulatory expertise to optimize methods and lead high-complexity investigations.

Responsibilities

• Provides front-line leadership for the QC Biochemistry team, serving as backup to the QC Manager and overseeing daily scheduling, shift meetings, accountability for team performance, and Quality decisions.
• Develops, mentors, trains, and motivates employees to achieve high performance, foster internal growth, and maintain alignment with current QC processes and procedures.
• Oversees and may execute routine Biochemistry testing of raw materials, intermediates, finished goods, and stability samples while ensuring regulatory compliance and accurate documentation from the QC Biochemistry team.
• Manages laboratory operations, including scheduling special testing requests, inventory maintenance, and ensuring proper use, maintenance, and troubleshooting of validated and calibrated instrumentation.
• Ensures all testing documentation is thorough, timely, and GDP-compliant, and maintains high standards of data integrity across all QC activities.
• Leads or oversees high-complexity investigations, including OOS, NCMR, CI, and CAPA, and supports audits as a subject matter expert using advanced analytical and regulatory knowledge.
• Recommends and authors SOP revisions and process improvements, supports LIMS data entry, maintenance, and review, and ensures team training remains current and compliant with departmental requirements.
• Enforces safety policies, ensures proper PPE use, and maintains a clean, organized, and cGLP-compliant audit-ready laboratory environment.
• Drives continuous improvement by identifying inefficiencies, adapting workflows, and participating in cross-functional initiatives to enhance productivity, efficiency, testing quality, and departmental culture.
• Supports departmental goal setting, validation activities, and other duties assigned by management to maintain operational readiness and quality standards.
• Performs all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, or Biomedical (highly preferred). In lieu of a Bachelor's degree, 4+ years of additional relevant experience in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing will be accepted.
• Experience working in a regulated Biochemistry or Chemistry laboratory with GxP testing.

Preferred Qualifications

• Proven technical and scientific knowledge working with relevant Chemistry and/or Biochemistry laboratory techniques and quality principles (GMP/GLP).
• Strong knowledge of domestic and international regulations and industry standards (ISO, QSR, UL, CSA, VDE) and experience supporting regulatory audits such as FDA, MDSAP, ISO, OSHA, and EPA.
• Extensive experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
• Strong organizational, leadership, and interpersonal abilities – training and developing staff, prioritizing multiple tasks, planning testing schedules, collaborating across levels, and authoring/redlining SOPs.
• Advanced analytical, problem-solving, documentation, and investigation skills, including data trending, report preparation, GDP compliance, and effective verbal and written communication.
• Ability to prioritize work, manage multiple tasks independently, and effectively collaborate in team-oriented environments.
• Proven ability to interpret, execute, and update SOPs, lead improvement initiatives, assess safety and environmental risks, and independently problem-solve with minimal supervision.

Skills

• Consistently upholds and reflects core ethical principles and values.
• Written communications – ability to communicate technical data in written form.
• Effective presentation skills – ability to present technical data.
• Leading without authority through influence and guidance of others towards a common goal.
• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.
• Inspires and energizes individuals to achieve their best performance.
• Skilled in MS Office tools including Outlook, Teams, Word, and Excel.
• Expert in applying technology; innovates, optimizes processes, and trains others.

Working Conditions & Physical Requirements

• Ability to remain in a stationary position, either sitting or standing, for prolonged periods.
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• No ability to adjust or move objects up to 50 pounds in all directions.

Additional Information

This position is in a fast-paced, FDA-regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Lead Analyst performs testing including Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, pO2 Headspace Analysis, and HPLC.

Reports to QC Manager, Biochemistry/BCID.

Pay

The salary range for this role in the state of North Carolina is $58,700 to $88,000 annually. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMérieux’s bonus program.

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.