Location: Barceloneta, PR

Responsibilities:

• Audit API and finished drug product electronic and manual (paper) batch records to ensure compliance with applicable CGMPs, internal policies, procedures, and regulatory guidelines.
• Document and assess deviations from approved procedures and specifications, making recommendations to ensure product quality requirements are met prior to release.
• Evaluate deviations in batch records and determine whether corrective actions are required.
• Participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies or other issues that may impact batch release.
• Review the manufacturing process, related equipment, and facilities to ensure compliance with procedures, specifications, and policies.
• Prepare batch record review packages and labels per approved retention procedures.
• Demonstrate accountability for Environmental, Health, and Safety (EHS) performance and compliance, promoting continuous improvement in all aspects of quality and safety management.
• Act as the contact person for projects as required, ensuring that project objectives are met in compliance with quality standards and timelines.
• Create lot lists for the Product Quality Review.
• Generate and prepare reports such as Right the First Time, Release Cycle Time, and delay reports.
• Enter required batch information into the lot restriction management system.
• Prepare Certificates of Analysis (COA) and Certificates of Compliance for API and finished drug products.
• Provide timely disposition to materials in the SAP system based on testing results and compliance with regulatory agency requirements.
• Track and trend batch record discrepancies per procedural requirements and collaborate with other departments (e.g., Manufacturing, Tech Ops, MS&T, MQA) to address discrepancies and reduce errors.

Requirements:

• Bachelor’s Degree in Science (preferably in Biology, Chemistry, Biotechnology), or Engineering.
• 2 years of experience working in a Biotechnology Manufacturing Plant in manufacturing or quality assurance roles.
• 1 year of experience working in highly computerized operations environments (e.g., MES systems, SAP).
• Knowledge and experience in the manufacturing of biotechnology products and understanding of CGMPs is required.

Qualifications:

• Strong understanding of the audit process and the ability to assess compliance with industry standards.
• Familiarity with aseptic processes and best practices in biotechnology manufacturing.
• Excellent written and verbal communication skills for documentation and cross-departmental collaboration.
• High level of accuracy and attention to detail in batch record review and compliance assessments.
• Ability to identify deviations, assess their impact, and recommend corrective actions to ensure product quality.
• Routine interaction with various departments, including Quality Control, Manufacturing, Materials, and Documentation.
• Review documentation and batch records regularly.
• Adhere to all Environmental, Health, and Safety requirements and work to continuously improve quality and safety standards in all areas of responsibility.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 28.90/hr.