About the Role:

• We are seeking a detail-oriented and proactive Quality Assurance Specialist to support key QA functions, including batch record management, product release, SOP oversight, and regulatory compliance.
• This individual will play a critical role in ensuring Good Manufacturing Practices (GMP) and maintaining quality standards in pharmaceutical manufacturing.

Pay Range: $40 - $45 an hr.

Key Responsibilities:

• Perform batch record management tasks, including retrieval, archiving, scanning, and filing.

• Complete batch record reviews and support release of intermediate and finished products for domestic markets.

• Generate and provide Certificates of Compliance (CoC) and Certificates of Analysis (CoA) as needed.

• Support internal and external audits by compiling relevant data and documentation.

• Participate in investigations and quality issue resolutions.

• Review and develop Standard Operating Procedures (SOPs) in compliance with GMP.

• Provide Quality Assurance review and approval of GMP-related SOPs.

• Manage Supplier Quality and additional QA-related documentation processes.

• Oversee proper allocation and maintenance of the Document Retention room.

• Assist with reconciliation of controlled print documents.

• Track and process Registered Country Table (RCT) tender requests within SAP.

• Contribute to continuous improvement initiatives and ensure adherence to regulatory expectations.

Qualifications:

• Education:

  • Bachelor’s degree (B.A./B.S.) in Science, Engineering, or a related field.

• Experience:

  • Minimum of 3 years of experience in a GMP-compliant pharmaceutical manufacturing facility.

  • Hands-on experience in batch record reviews, documentation, product release, and quality systems.

• Technical Skills:

  • Proficiency in SAP and Veeva Systems.

  • Knowledge of QA tools and compliance standards.

• Soft Skills:

  • Excellent communication (written and verbal) and teamwork abilities.

  • Strong attention to detail and time management.

  • Ability to manage multiple tasks under pressure and meet project deadlines.

  • Skilled in identifying issues and implementing standard procedures for resolution.

  • Capable of working independently and making informed decisions using data and trending analysis.