About the Role:

• We are seeking a Specialist, Quality Assurance to join our team.
• The ideal candidate will be responsible for supporting batch record management, generating batch conformance documentation, completing batch record reviews, supporting investigations, compiling data for audits and inspections, developing SOPs, and other Quality Assurance functions as needed.
• The Specialist must demonstrate leadership, critical thinking, and the ability to work independently to ensure timely and reliable completion of job responsibilities.

Pay Range: $40 - $45

Responsibilities: -

• Retrieve and track site Batch Records
• Prepare Certificate of Compliance (CoC) and Certificate of Analysis (CoA) 
• Assist with document retention and reconciliation
• Support tracking and processing of tender request forms
• Review batch records and release products for distribution
• Provide Quality Assurance review of SOPs

Education Qualification:

• Must possess a B.A. /B.S. degree, preferably in Science or Engineering.

Required Skills: -

• Advanced knowledge of information systems (SAP and Veeva Systems preferred)
• Minimum of three (3) years’ experience in GMP pharmaceutical manufacturing
• Strong written and oral communication skills
• Attention to detail and problem-solving abilities
• Proficient in time management
• Ability to analyze problems and identify solutions
• Flexible, able to multitask, and work under pressure
• Proactive in utilizing data trends for process improvement