QC Lead Analyst

Position Summary

The Quality Control (QC) Biochemistry Lead Analyst provides 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. The Lead Analyst applies advanced analytical and regulatory expertise to optimize methods and lead high-complexity OOS, NCMR, CI, and CAPA investigations. They are responsible for developing employees, managing projects, maintaining laboratory operations, driving accountability for team performance, and leading quality initiatives that improve testing processes. This position enhances departmental productivity, efficiency, testing quality, and culture by identifying inefficiencies, adapting workflows, and collaborating across the organization to drive productivity and continuous improvement.

Primary Duties

• 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 and 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.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications

Required Education, Training and Experience

• Bachelor's degree and no previous experience required. Bachelor’s degree highly preferred in Chemistry, Biochemistry, or Biomedical.
• Education Substitution: In lieu of a Bachelor's degree, 4+ years of additional relevant experience, defined below, will be accepted.
• Experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing.

Preferred Education, Training and Experience

• Proven technical and scientific knowledge working with relevant Chemistry and/or Biochemistry laboratory techniques and quality principles (GMP/GLP) preferred.
• Demonstrates strong knowledge of domestic and international regulations and industry standards (ISO, QSR, UL, CSA, VDE) and has 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.
• Shows strong organizational, leadership, and interpersonal abilities – training and developing staff, prioritizing multiple tasks, planning testing schedules, collaborating across levels, and authoring/redlining SOPs.
• Exhibits advanced analytical, problem-solving, documentation, and investigation skills, including data trending, report preparation, GDP compliance, and effective verbal and written communication.
• Strong organizational, communication, and leadership skills with the 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 and provide solutions with minimal supervision.

Key Skills (Knowledge, Skills & Abilities)

• 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.
• Effective Presentation Skills – including the ability to present technical data.
• Leading without authority through influence and guidance of others towards a common goal by using expertise, persuasion, and personal qualities to inspire action.
• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.
• Inspire and energize individuals to achieve their best performance.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.
  • Expert: leads in applying technology; innovates, optimizes processes, and trains others.

Working Conditions & Physical Requirements

Physical Requirements

• Ability to remain in 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.

Travel Requirements

• Domestic travel required: 0%
• International travel required: 0%
• Total travel: 0%

Additional Position Information

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

Reports To

QC Manager, Biochemistry/BCID

Supervisory Responsibilities

• Direct supervision: 0 (Not applicable)
• Indirect supervision: 0 (Not applicable)