cGMP QA Document Control & Compliance Specialist

BINJU PATEL

732-***-**** ********@*****.***

PROFESSIONAL SUMMARY

Detail-oriented Quality Assurance professional with 5+ years of pharmaceutical industry experience in QA, document control, stability programs, manufacturing, and packaging operations. Experienced in cGMP compliance, SOPs, controlled documentation, batch records, change control, and quality systems. Strong background collaborating with QA, QC, Manufacturing, Regulatory Affairs, and R&D to maintain accurate, compliant documentation and support quality operations. PROFESSIONAL EXPERIENCE

Strive Pharmaceutical - East Brunswick, NJ

QA Associate

• Maintained master and controlled documents, including SOPs, batch records, logbooks, and forms, supporting compliant document control and GxP recordkeeping.

• Reviewed packaging batch records and quality documentation for accuracy, completeness, compliance, and discrepancies.

• Performed QA oversight of manufacturing and packaging operations, including line clearance, room/equipment release, in-process sampling, labeling verification, and documentation review.

• Maintained retained samples, completed annual retained sample inspections, and documented activities in accordance with established procedures.

• Reviewed artwork and supported warehouse documentation, labeling, material inspection, and incoming/outgoing packaging material compliance.

Apnar Pharma LLP - East Windsor, NJ

QA Associate Apr. 2022 - Mar. 2026

• Managed the lifecycle of controlled GxP documents, including SOPs, batch records, MMRs, MPRs, protocols, specifications, forms, and quality manuals in compliance with cGMP requirements.

• Issued, reviewed, tracked, revised, approved, archived, and maintained version control of quality documents and Excel-based tracking logs to ensure accuracy and traceability.

• Reviewed manufacturing and packaging records and supported change control, deviations, CAPAs, audit observations, and training documentation.

• Collaborated with QA, QC, Manufacturing, Regulatory Affairs, and R&D to resolve documentation issues and implement document changes in a timely, compliant manner.

• Managed stability program activities, including protocol review, study initiation, pull schedule management, and documentation tracking.

• Supported internal, customer, and regulatory audits by retrieving and organizing controlled quality records; trained employees on cGMP documentation, data integrity, and document control procedures. Sun Pharma - New Jersey, USA

Packaging Coordinator Jul. 2021 - Apr. 2022

• Operated and monitored packaging equipment while performing in-process checks in accordance with SOPs.

• Reviewed packaging batch records, material reconciliation, and batch closing documentation for completeness and accuracy. Aurobindo Pharma - East Windsor, NJ

Packaging Machine Operator Sep. 2019 - Jul. 2021

• Operated packaging line equipment including labelers, unscramblers, desiccant inserters, tablet counters, cottoners, and cappers.

• Maintained accurate packaging batch records, reconciled materials, and documented rejected material disposition. SKILLS

• cGMP & SOP Compliance • Change Control

• GxP Documentation • Data Review & Discrepancy Identification

• Document Control & Archiving • Cross-Functional Collaboration

• Batch & Manufacturing Records • Microsoft Excel & Word

• Stability Documentation • Adobe PDF Tools

EDUCATION

Sahajanand College - Gujarat, India Bachelor of Commerce (B.Com.)

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