What are the responsibilities and job description for the Quality Control Manager – Dietary Supplements (Powders, Capsules, Tablets) position at SMK Global?
Company Overview
We are a fast-growing manufacturing company based in New Jersey. Our operations include dietary supplement manufacturing across powder products as well as solid dose products (tablets and capsules). As we expand our manufacturing and quality systems, we are seeking an experienced Quality Control Manager to lead laboratory operations, in-process quality oversight, and testing programs.
Role Overview
This role is responsible for leading day-to-day Quality Control laboratory operations for dietary supplements, including in-house testing, stability monitoring, method oversight, team management, and coordination of outsourced active analytical testing.
This is a hands-on management role. The position will directly oversee and strengthen in-house capabilities for raw material identification, botanical ID, microbiological testing, physical testing, stability monitoring, and the implementation of ICP-MS testing for minerals and heavy metals.
A significant portion of active ingredient testing (~65%) is conducted through qualified third-party laboratories using HPLC, UHPLC, and related methodologies. This role will serve as the internal supervisory lead for these activities, including vendor qualification, coordination, data review, and final quality assessment.
Key Responsibilities
QC Laboratory Management
- Lead and manage all QC laboratory operations for raw materials, in-process materials, and finished products
- Supervise, train, and develop a QC lab team (4 staff) and warehouse/IPQC personnel (2 staff)
- Manage lab scheduling, workload prioritization, and turnaround times
- Ensure strong documentation, data integrity, and compliance practices
In-House Testing Oversight
- Oversee and perform in-house testing including:
- Botanical ID testing (HPTLC)
- Raw material identity testing (FTIR)
- Microbiological testing (3M methods)
- Physical testing (particle size, swab testing, etc.)
- Stability testing programs and monitoring
- Maintain SOPs, methods, and training for in-house lab operations
ICP-MS Implementation
- Lead implementation of ICP-MS testing for heavy metals and minerals
- Coordinate instrument selection, setup, qualification, and workflow integration
- Work with internal teams and external experts as needed
Third-Party Active Analytics Oversight
- Manage outsourced testing (~65% workload) for active ingredient analysis using HPLC, UHPLC, and related methods
- Qualify and manage external laboratories
- Coordinate sample submission and testing timelines
- Review COAs, chromatographic data, and analytical reports
- Investigate OOS or atypical results and ensure timely resolution
- Ensure third-party testing supports product release and compliance
Compliance and Quality Systems
- Ensure compliance with 21 CFR Part 111 and applicable FDA requirements
- Maintain and improve QC SOPs, documentation, and lab systems
- Support audits (internal, customer, regulatory)
- Lead or support investigations, deviations, CAPA, and OOS/OOT processes
IPQC and Warehouse Quality
- Oversee in-process quality control activities in warehouse and production
- Ensure proper sampling, material status control, and release procedures
- Coordinate closely with production and operations teams
Contract Manufacturing & Vendor Quality
- Support quality oversight of contract manufacturing partners
- Review supplier and CMO documentation, COAs, and specifications
- Ensure external partners meet quality and regulatory standards
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field
- 10 years of experience in dietary supplements, nutraceuticals, or similar regulated manufacturing
- Hands-on experience with:
- HPTLC
- FTIR
- Microbiological testing (3M methods)
- Physical testing
- Stability programs
- Experience managing QC lab teams
- Experience overseeing outsourced analytical testing
- Familiarity with HPLC/UHPLC-based testing (review/oversight level)
- Experience with ICP-MS (implementation or oversight preferred)
- Knowledge of cGMP (21 CFR Part 111)
- Contract manufacturing experience is a plus
Ideal Candidate Profile
- Hands-on QC leader with strong technical and supervisory capabilities
- Strong analytical data review and decision-making skills
- Experience balancing in-house testing and outsourced lab management
- Practical, organized, and business-oriented mindset
- Strong cross-functional communication skills
Work Location: In person