Biomedical Documentation Reviewer

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Responsibilities

• Performs reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinates and tracks CAPA, NCR and Deviation records, ensuring tasks are completed on time.
• Coordinates and tracks the site environmental monitoring (EM) testing program.
• Assists teams in coordination of problem solving and root cause analysis for associated quality events.
• Ensures the development, review, and release of quarterly EM trending reports; Assures significant trends are immediately brought to management attention.
• Provides input based on knowledge and experience with batch release requirements.
• Provides QMS Operations related support to all CGMP departments.
• The Quality Analyst will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provides support related to gowning qualification and training.
• Ensures timely issuance, review, and approval of Microbiology and EM testing results.
• Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Assists in the review and approval of equipment qualifications.
• Assists in the review of Calibration and Preventative Maintenance reviews.

Skills & Qualifications

• Bachelor’s Degree in a Life Science discipline and/or in a related field.
• Experience in an FDA-regulated environment, particularly medical device, human tissue or pharmaceutical manufacturing preferred.
• Experience with Microsoft Excel.
• Experience writing Standard Operating Procedures and Work Instructions.