SMC Ltd · 10 hours ago
Analytical and Quality Control Lab Manager
Concord, NC
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expSMC Ltd. is a globally recognized premium supplier to the medical market, seeking an Analytical and Quality Control Lab Manager. The role involves overseeing lab operations, ensuring compliance with quality standards, and managing a team of scientists and technicians.
ManufacturingMedical Device
Responsibilities
Oversee day-to-day activities, coordinate testing schedules, and manage sample throughput and result reviews for accuracy and trends to meet project deadlines
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
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
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
Ensure adherence to regulatory standards (CLIA, ISO, FDA, ICH, etc.) and function as a subject matter expert during internal/external audits
Lead investigations for out-of-specification (OOS) results, implement Corrective and Preventive Actions (CAPAs)
Analyze results, prepare detailed reports (Certificates of Analysis), and communicate findings to management, clients, and collaborators. Track KPIs, and report on performance, issues, and improvements to management
Manage lab inventory, supplies, equipment procurement, and laboratory budgets effectively. Negotiate with vendors for supplies and service contracts
Recruit, hire, and mentor a team of scientists and technicians. Schedule staff and manage performance through training and career development
Enforce strict safety protocols, including proper PPE usage and hazardous waste disposal according to OSHA and EPA guidelines
Other duties as assigned
Qualification
Required
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
Preferred
Master's or PhD in Chemistry
Benefits
Clean, Climate-Controlled Environment
Stable schedule
Paid holiday and PTO
Health, dental, and vision insurance
401(k) retirement savings
Life and disability insurance
Promotional opportunities
Training and career growth programs
Amazing co-workers
Tuition reimbursement
Employee Assistance Program
Company
SMC Ltd
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries.
501-1000 employees
H1B Sponsorship
SMC Ltd has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Carlos Castro
Talent Acquisition Partner
Jeff Burke
Human Resource Partner
Company data provided by crunchbase