Associate I, Quality Control Compliance/Data Review

job summary :

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responsibilities :

The Quality Control Microbiology Compliance Data Review Associate I is responsible for the review and verification of microbiological data to ensure accuracy, compliance with regulatory standards, and adherence to company policies.

This role plays a crucial part in maintaining the integrity of the quality control process and ensuring the safety and efficacy of products.

Data Review :

• Review microbiological test data for accuracy, completeness, and compliance with GMP (Good Manufacturing Practices) and company SOPs (Standard Operating Procedures).
• Verify calculations, data entries, and test results for microbiological assays including but not limited to bioburden, endotoxin, sterility, and environmental monitoring.
• Ensure that all data is recorded and reported according to regulatory requirements and company standards.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Documentation :

• Maintain accurate and detailed records of all data reviews.
• Prepare and review Certificates of Analysis (CoA) and other quality documentation.
• Ensure all documentation is audit-ready and complies with regulatory standards.

Compliance :

• Ensure compliance with FDA, EMA, and other regulatory agencies’ guidelines.
• Participate in internal and external audits and inspections as needed.
• Identify and report any deviations or non-conformances in the data and collaborate with the QC team to resolve them.

Continuous Improvement :

• Assist in the development and implementation of quality control procedures and policies.
• Participate in continuous improvement initiatives to enhance data review processes and overall quality control.

Collaboration :

• Work closely with the Quality Assurance, Production, and R&D teams to ensure seamless communication and coordination.
• Collaborate with the QC Microbiology team to ensure timely and accurate data review.

Physical Requirements :

• Ability to sit or stand for extended periods.
• Ability to work in a laboratory environment with exposure to biological and chemical hazards.

qualifications :

• High School Diploma
• Previous experience in the biotechnology / biopharmaceutical industry, or other regulated industry a plus
• Experience in biopharmaceutical & GMP.
• Strong attention to detail and analytical skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and as part of a team.
• Strong organizational and time management skills.

skills :

Quality control, SOP, MS-WORD, MS-EXCEL, MS-Powerpoint, Microbiology, GMP (Good Manufacturing Practice)