Quality Specialist Jobs in New York

Overview

The specialist collaborates closely with overseas manufacturers, internal departments, regulatory partners, and Vita Warehouse to ensure that finished products are accurately documented, properly labeled, compliant with regulatory requirements, and supported by complete quality documentation prior to release and distribution. The role requires a strong understanding of dietary supplement testing, botanical ingredients, product formulations, Supplement Facts requirements, labeling compliance, and documentation control within a cGMP-regulated environment.

Primary Responsibilities

• Develop and maintain a thorough understanding of the Company's products, formulations, ingredients, and quality requirements.
• Collect, organize, review, and maintain quality, regulatory, testing, formulation, labeling, and compliance documentation from suppliers and manufacturers, including Certificates of Analysis (COAs), specifications, batch records, allergen statements, manufacturing declarations, and related quality documents.
• Review documentation for completeness, accuracy, consistency, and compliance with company standards and regulatory requirements.
• Track and resolve missing, incomplete, outdated, or non-conforming documentation.
• Maintain electronic and physical document control systems in accordance with company SOPs and record retention requirements.
• Review and evaluate laboratory reports, COAs, and testing documentation for dietary ingredients, botanical raw materials, and finished dietary supplements.
• Verify that all required testing has been completed and meets approved specifications, including identity, potency, microbiological, heavy metals, contaminants, and stability testing.
• Prepare, package, and submit raw materials, bulk products, finished products, and stability samples to qualified contract laboratories for analysis.
• Maintain testing schedules and records of sample submissions, chain-of-custody documentation, laboratory communications, and final reports.
• Assist with investigations, retesting activities, and resolution of out-of-specification (OOS) or non-conforming results.
• Review stability data and support shelf-life and expiration dating programs.
• Review and verify product formulations, ingredient specifications, ingredient statements, Supplement Facts panels, and label claims for accuracy and compliance.
• Ensure consistency between formulations, specifications, testing results, labels, artwork, and approved product documentation.
• Review botanical ingredient documentationto ensure proper identification, authentication, extract standardization, and compliance with established quality requirements.
• Maintain records supporting label approvals, artwork revisions, specification updates, product changes, and document version control.
• Support supplier qualification activities, audits, inspections, investigations, and continuous improvement initiatives.
• Contribute to the development and improvement of SOPs and quality documentation systems.
• Serve as a key participant in cross-functional efforts involving RV Pharma, Vita Warehouse, overseas manufacturers, suppliers, and contract laboratories to support product quality, compliance, and release activities.
• Collaborate with Vita Warehouse to ensure labels, packaging components, artwork, and finished product documentation accurately reflect approved formulations, specifications, and regulatory requirements.
• Coordinate label, artwork, and packaging reviews with Regulatory Affairs, Quality Assurance, and Product Development teams.
• Work closely with Supply Chain, Operations, and Quality departments to support product releases and inventory movement.
• Communicate documentation deficiencies, testing concerns, corrective actions, and compliance requirements to internal and external stakeholders.
• Coordinate laboratory testing activities, sample submissions, and result follow-up with external laboratories.
• Assist in resolving discrepancies involving formulas, specifications, test results, Supplement Facts panels, labels, artwork, packaging materials, and supplier documentation.
• Support supplier qualification, new product launches, formula revisions, and product change-control activities.
• Ensure effective communication and timely completion of documentation and compliance requirements necessary for product release and distribution.
• Participate in audits, investigations, and continuous improvement initiatives as assigned.

REQUIRED SKILLS

• Strong knowledge of FDA dietary supplement regulations, including 21 CFR Part 111 and 21 CFR Part 117.
• Working knowledge of dietary supplement quality systems, cGMP requirements, and documentation control practices.
• Understanding of dietary supplement testing requirements, including identity, potency, assay, microbiological, heavy metal, contaminant, and stability testing.
• Ability to interpret laboratory reports, Certificates of Analysis, specifications, and manufacturing documentation.
• Knowledge of dietary supplement formulations, ingredient specifications, active and inactive ingredients, vitamin and mineral blends, and specialty ingredients.
• Knowledge of botanical ingredients and plant-derived materials, including roots, leaves, stems, bark, flowers, fruits, seeds, extracts, standardized extracts, botanical authentication, and marker compounds.
• Strong understanding of Supplement Facts panels, FDA labeling requirements, ingredient declarations, serving sizes, daily values, label claims, and formulation verification.
• Knowledge of stability programs, shelf-life determination, and expiration dating requirements.
• Experience coordinating product testing and laboratory submissions.
• Excellent analytical, organizational, problem-solving, and critical-thinking skills.
• Strong attention to detail and ability to identify discrepancies within technical documentation.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities, projects, and deadlines in a fast-paced environment.
• Proficiency in Microsoft Office and electronic document management systems.
• Commitment to quality, accuracy, and regulatory compliance.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Associate's or Bachelor's degree in Chemistry, Biology, Food Science, Quality Assurance, Regulatory Affairs, or related scientific discipline preferred.
• Minimum 2-5 years of experience in dietary supplements, nutraceuticals, food manufacturing, or another cGMP-regulated environment.
• Experience reviewing laboratory testing documentation, Certificates of Analysis, formulations, specifications, labels, and quality records preferred.
• Experience working with botanical ingredients, dietary supplement formulations, and Supplement Facts panels strongly preferred.

Pay: $55,000.00 - $70,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Work Location: In person