QA Associate – Batch Records & Formulation Review (Part-Time, Remote – Evening Shift)

Location: Remote (India-based)

Shift Timing: 7:00 PM – 11:00 PM IST (4 hours/day, Monday–Friday) — overlaps with North American business hours (9:30 AM–1:30 PM ET / 6:30 AM–10:30 AM PT)

Employment Type: Part-time / Contract

Industry: Pharmaceuticals / Nutraceuticals / Natural Health Products (US & Canada markets)

About the Role

We're looking for a QA Associate with a pharma or natural health products background and working knowledge of US FDA and Health Canada regulatory frameworks to remotely review batch manufacturing records, formulation documentation, and quality certificates. This role ensures our products meet regulatory standards for the North American market before release, working a fixed evening shift that overlaps with our US/Canada team's morning hours.

Key Responsibilities

• Review Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) for completeness, accuracy, and compliance with cGMP
• Cross-check formulation sheets against approved master formulas and product specifications
• Review Certificates of Analysis (COAs) from suppliers/labs for raw materials and finished products
• Verify documentation aligns with US FDA 21 CFR Part 111 (dietary supplement cGMP) or 21 CFR Part 210/211 (pharmaceutical cGMP), as applicable
• Verify documentation aligns with Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) requirements, including Site Licence (SL) and Product Licence (NPN) documentation standards
• Flag deviations, missing entries, out-of-spec (OOS) results, or documentation gaps for follow-up
• Support preparation of documentation for FDA inspections or Health Canada audits
• Maintain accurate logs of reviewed records and escalate discrepancies to the QA lead
• Coordinate with production, formulation, and regulatory affairs teams (async) on clarifications

Requirements

• Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, or related field
• 1–3 years of experience in pharma/nutraceutical QA, QC, or regulatory affairs
• Working knowledge of cGMP documentation practices under US FDA (21 CFR 111 or 210/211) and/or Health Canada NNHPD frameworks
• Familiarity with NPN (Natural Product Number) licensing documentation and/or FDA dietary supplement labeling/claims requirements
• Strong attention to detail and ability to spot inconsistencies in technical/regulatory documents
• Comfortable working independently and reviewing documents digitally (PDFs, ERP/QMS software)
• Strong written English for documentation and communicating with a North American team

Nice to Have

• Experience with QMS software (MasterControl, TrackWise, Veeva Vault, or similar)
• Prior work supporting FDA 483 responses or Health Canada compliance audits
• Exposure to herbal/natural health formulations, dietary supplements, or OTC monograph products
• Understanding of stability testing, shelf-life documentation, and structure/function claims review

What We Offer

• Fully remote, fixed 4-hour evening shift aligned with North American mornings (no weekend work)
• Flexible part-time role — good fit for experienced professionals seeking supplemental work
• Exposure to US/Canada regulatory and quality processes in a growing natural health products company