Qa Specialist

• Monday to Friday, 8:00 AM to 5:00 PM
• Flexible hours may be arranged if needed
• Overtime may be required based on business needs

• Primarily office-based
• Occasional visits to production areas as required
• Collaborative work with cross-functional teams

• Review and audit batch records (electronic and paper) for API and finished products to ensure compliance with GMP and internal procedures
• Identify discrepancies in batch records and recommend corrective actions
• Investigate deviations, exceptions, and nonconformance reports
• Perform product disposition in SAP based on testing results and compliance requirements
• Prepare Certificates of Analysis and Certificates of Compliance
• Enter and verify batch data in internal systems, including lot management tools
• Track and trend batch record discrepancies and collaborate with teams to reduce errors
• Prepare reports related to quality metrics, audit requests, and product quality reviews
• Participate in cross-functional meetings to discuss batch status and release timelines
• Maintain compliance with environmental, health, and safety standards

• Bachelor's degree in Biology, Chemistry, Biotechnology, Engineering, or related science field
• Minimum of 2 years of experience in a pharmaceutical, biotechnology, or chemical manufacturing environment
• Experience with batch record review, deviation investigation, and audit processes
• Knowledge of cGMP, quality systems, and regulatory requirements (such as FDA guidelines)
• Experience working with computerized systems such as SAP, LIMS, or MES
• Strong analytical, problem-solving, and communication skills
• Proficiency in written and spoken English

• Health insurance

• Batch Record Review: 1 year (Preferred)

• Barceloneta, PR (Preferred)

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