Senior QA Validation Lead for GMP/OTC Systems

LNK International, Inc.; Town of Smithtown (NY); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

LNK International, a leading OTC pharmaceutical manufacturer in Hauppauge, NY, seeks an experienced Quality Assurance Validation Manager to join a fast-paced team. The role reports to the Director of Quality Assurance and involves comprehensive QA oversight of validation activities for solid and liquid OTC products in a cGMP environment.

Candidates should demonstrate 5+ years of validation experience, 2+ years in leadership, and strong expertise in regulatory compliance, IQ/OQ/PQ, and computer

Qualifications

• Bachelor's degree in a scientific field as listed.
• 5+ years of validation experience in FDA-regulated pharma/OTC.
• 2+ years of supervisory or managerial experience.
• Experience with QA batch record auditing, compliance or validation.
• Experience in software configuration, installation and/or system integration.

Responsibilities

• Leads QA input to validation projects for solid and liquid OTC products.
• Maintains the site Master Validation Plan (MVP) aligned with FDA/OTC expectations.
• Advises on compliance/technical issues to achieve company policy compliance.
• Reviews validation docs (specs, protocols, reports) focusing on cGMP, IQ/OQ/PQ.
• Reviews commissioning/validation docs for manufacturing equipment (e.g., tablet presses, mixers).
• Guides project teams on regulatory compliance and validation strategies.
• Provides QA input to Computer validation in a cGMP environment.

Skills

QA Validation

Regulatory Compliance

Team Leadership

Software Validation

Education

Bachelor's degree in Engineering, Chemistry, Biology, Pharmacy

Tools

IQ/OQ/PQ

Computer Validation

Job description

LNK International, a leading OTC pharmaceutical manufacturer in Hauppauge, NY, seeks an experienced Quality Assurance Validation Manager to join a fast-paced team. The role reports to the Director of Quality Assurance and involves comprehensive QA oversight of validation activities for solid and liquid OTC products in a cGMP environment.

Candidates should demonstrate 5+ years of validation experience, 2+ years in leadership, and strong expertise in regulatory compliance, IQ/OQ/PQ, and computer