Analytical and Quality Control Lab Manager

SMC Ltd.•Concord, NC

About The Position

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people. Job Summary: The Analytical and Quality Control Lab Manager will set up and maintain the analytical lab, oversee daily lab operations, ensure compliance with quality and safety standards, own specifications and material release, develop and transfer methods and troubleshoot technical issues, maintain data integrity, and drive continuous improvement, and focus on accurate testing of materials, processes, and finished products.

Requirements

Bachelor’s degree in chemistry with at least 10 years’ experience.
5-7+ years of relevant laboratory experience, with at least 1–3 years in a supervisory or management capacity.
Proven experience in QC/QA, especially in regulated environments.
Knowledge of GMP, GDP, ISO, USP/NF, EU, JP, etc. relevant regulations.
Hands-on expertise with specific analytical techniques (e.g., GC, HPLC, etc.)
Strong leadership, communication, and organizational skills are critical for managing cross-functional teams and external stakeholders.
Ability to read, write and communicate in English.

Nice To Haves

Master’s or PhD in Chemistry.

Responsibilities

Operations Management: Oversee day-to-day activities, coordinate testing schedules, and manage sample throughput and result reviews for accuracy and trends to meet project deadlines.
Equipment, Method, & System Validation: Support procurement and validation of equipment as well as transfer and validation of analytical methods to ensure compliance with USP/NF, EU, JP, and other compendial testing requirements.
Technical Expertise: Provide technical guidance, troubleshoot complex issues, validate and ensure proper calibration and maintenance of instruments (HPLC, GC-MS, etc.). Develop a constant lifecycle of equipment. Develop methods and testing including releasing incoming material testing, in process testing, and final product.
Quality Systems and Management: Implement and manage Quality Management Systems (QMS) and SOPs, ensure data integrity and that all laboratory records are auditable, accurate. Author and support material specifications as well as SOPs.
Compliance & Compliance: Ensure adherence to regulatory standards (CLIA, ISO, FDA, ICH, etc.) and function as a subject matter expert during internal/external audits.
Deviation & CAPA: Lead investigations for out-of-specification (OOS) results, implement Corrective and Preventive Actions (CAPAs).
Reporting & Communication: Analyze results, prepare detailed reports (Certificates of Analysis [https://www.google.com/search?q=Certificates+of+Analysis&sca_esv=8aae2c49ac4789b3&source=hp&ei=1LJnacLHN_iP8L0PhZObkQY&iflsig=AFdpzrgAAAAAaWfA5K2Mh6offlC-CMbHypbqVUwA7Yn5&oq=Analytical+lab+manager&gs_lp=Egdnd3Mtd2l6IhZBbmFseXRpY2FsIGxhYiBtYW5hZ2VyKgIIAzIFEAAYgAQyBRAAGIAEMgYQABgWGB4yBhAAGBYYHjIGEAAYFhgeMgYQABgWGB4yBhAAGBYYHjIGEAAYFhgeMgYQABgWGB4yBhAAGBYYHkjVVVCtB1jnRnABeACQAQCYAbICoAGaFqoBCDMuMTguMC4xuAEByAEA-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&sclient=gws-wiz&mstk=AUtExfBM3pa6QX_HTlCj_a2w6FJ31ihBPTNSYv5OIF8Id07egwGwUrD0WTxRKNIkokZImaX6q3D0S4F-0x4M8fZoF__9AIplnVBTWyGIfhPZ-4brnrH7aD2TWBjTjHohvYG68hw&csui=3&ved=2ahUKEwi31ZuKqYuSAxXZGtAFHXk1K6kQgK4QegQIBBAK]), and communicate findings to management, clients, and collaborators. Track KPIs, and report on performance, issues, and improvements to management.
Resource & Budget Management: Manage lab inventory, supplies, equipment procurement, and laboratory budgets effectively. Negotiate with vendors for supplies and service contracts.
Personnel Management: Recruit, hire, and mentor a team of scientists and technicians. Schedule staff and manage performance through training and career development.
Safety Oversight: Enforce strict safety protocols, including proper PPE usage and hazardous waste disposal according to OSHA and EPA guidelines.
Other duties as assigned.