Quality Control Microbiology Data Review

Responsibilities

• Review executed QC test records for product release (including Environmental Monitoring Data).
• Review Logbooks and Laboratory Notebooks.
• Supports authoring and revision of laboratory procedures, test record forms and reports.
• Participate in quality systems records such as deviations, change controls, CAPAs, and non-conformance investigations.
• 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.
• Ensure compliance with cGMP documentation and regulatory guidelines.
• Establish and maintain a safe laboratory working environment.
• Provide support during internal and vendor audits and collaborate on continuous improvement initiatives.

Qualifications

• STEM degree
• Experience in a cGMP laboratory setting, with hands-on experience in microbiology techniques is preferred, but not required.
• Experience with microbiology test methods (growth promotion, bioburden, culture purity, endotoxin).
• Experience with environmental monitoring
• Experience in technical writing
• Familiarity with electronic databases (e.g. LIMS, MODA, SAP).
• Understanding of relevant and current FDA, EU, ICH guidelines and regulations.
• Experience with laboratory equipment calibration and maintenance.

Skills

• Laboratory Information Management Systems (LIMS)
• Electronic Laboratory Notebook (ELN)
• Good Manufacturing Practices (GMP)

Pay

Salary offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

Schedule

Work hours: 3 to 11

Benefits

Comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).