08 Nov
|
PRIME NUTRISOURCE
|
Scarborough
08 Nov
PRIME NUTRISOURCE
Scarborough
Job Overview
We are seeking a highly organized and analytical QC Lab Technician and R&D; Associate to join our growing team. This dual-focused role splits responsibilities between ensuring the highest standards of safety, identity, and purity (QC) and driving market-ready innovation through new product development (R&D;). You will own the process from raw material verification and benchtop prototyping to final product release.
All duties are performed in strict adherence to Health Canada and Non-prescription Health Products Directorate (NNHPD) regulations,
FDA cGMPs, and internal Standard Operating Procedures (SOPs).
Detailed Responsibilities
Quality Control (QC)
● Routine Job & Batch Analysis: Conduct routine, day-to-day physical, chemical, and organoleptic testing on incoming raw materials, botanical extracts, active ingredients,
blends, and finished batches. This includes executing timely analysis for moisture content, disintegration, capsule weight variation, HPLC, and friability to ensure every batch meets rigid specifications before moving to the next production phase.
● Instrument Calibration & Verification: Take ownership of the daily calibration and verification protocols for all laboratory equipment (e.g., analytical balances, pH meters,
and moisture analyzers) against certified reference standards before use. Maintain precise instrument logbooks to guarantee audit readiness.
● Environmental & Microbial Monitoring: Conduct routine environmental monitoring of the manufacturing facility (air quality settling plates, surface swabs) and coordinate or perform microbiological limit testing (such as Total Aerobic Microbial Count, yeast, mold,
and pathogens).
● Stability & Shelf-Life Studies: Establish, pull, and test samples for real-time and accelerated stability programs. Analyze data to determine, extend, or justify product expiration dates.
● Documentation & Data Integrity: Review and approve Certificates of Analysis (CoA),
write and update lab-specific SOPs,
and maintain flawless batch and laboratory records to support external regulatory audits.
● OOS & CAPA Management: Lead investigations into Out-of-Specification (OOS) test results, deviation reports, and customer complaints. Draft, execute, and close out
Corrective and Preventive Action (CAPA) plans.
Research & Development (R&D;)
● Innovative Formula Design: Research, design, and formulate next-generation dietary supplements across multiple delivery forms (capsules, tablets, softgels, functional powders, liquids, and gummies).
● Benchtop Prototyping: Formulate and prepare benchtop or pilot-scale batches.
Optimize organoleptic profiles using clean-label masking techniques, natural sweeteners, and flavors.
● Feasibility & Raw Material Sourcing: Evaluate active ingredients and excipients for technical compatibility, stability, cost-efficiency, and regulatory compliance (e.g.,
checking Health Canada NNHPD ingredients database or FDA GRAS status).
● Tech Transfer & Pilot Scale-Up: Partner with the Production team to transition bench formulas to commercial-scale machinery. Troubleshoot manufacturing issues like powder segregation, capping, sticking, or poor flowability.
● Master Records & Product Dossiers: Create Master Formulation sheets, Master Batch
Production Records (MBPRs), and product specifications. Provide technical documentation to support NPN (Natural Product Number) applications or structure-
function claims.
● Competitive Analysis: Monitor industry trends, novel delivery systems, and patented raw materials to suggest line extensions or product improvements.
Requirements & Qualifications
Education
● Minimum Requirement: Bachelor's degree in Chemistry, Pharmaceutical Sciences,
or a related scientific discipline.
Professional Experience
● Required: 1–3 years of hands-on laboratory testing, routine batch analysis, or product formulation experience directly within the nutraceutical, dietary supplement,
pharmaceutical, or functional food industries.
Technical Skills & Competencies
● Instrument Metrology & Calibration: Proven capability to perform routine calibrations,
troubleshoot basic instrument drifts, interpret diagnostic errors, and maintain strict data integrity tracking for laboratory instrumentation.
● Analytical Chemistry: Proven proficiency operating and interpreting data from HPLC,
GCMS, FTIR, and UV-Vis software.
● Powder Mechanics & Galenics: Solid understanding of ingredient solubility,
bulk/tapped density, particle size distribution, and how excipients interact under compression or encapsulation.
● Statistical Quality Control: Familiarity with sampling plans (e.g., ANSI/ASQ Z1.4), data analysis, and trending stability data.
● Software: High proficiency with Microsoft Excel (for data tracking and stability modeling); experience using Simplicity is highly desirable.
Regulatory Acumen
● Strict, working knowledge of Positive Manufacturing Practices for Natural Health Products
(Health Canada or site licensing requirements) or U.S. FDA 21 CFR Part 111
(Dietary Supplements).
● Experience writing technical documentation destined for regulatory review or audit presentation.
Physical & Soft Skills
● Attention to Detail: Meticulous approach to recording data; mistakes in documentation or testing are caught early.
● Problem-Solving: Ability to approach a failed bench batch or a weird QC test result systematically using root-cause analysis.
● Physical Demands: Ability to stand for extended periods in a lab setting, handle chemical reagents safely, and lift pilot-scale in
Pay: $20.00-$25.00 per hour
Expected hours: 40.0 per week
Experience
- QC/R&D; Lab: 1 year (required)
Work Location: In person
📌 QC Laboratory Technician and R&D Associate (Scarborough)
🏢 PRIME NUTRISOURCE
📍 Scarborough