Manufacturing - Biomanufacturing Quality Assurance Floor Support

Biomanufacturing Quality Assurance Floor Support

This role is 100% Onsite. Work schedule is: 5AM - 5PM, 12 hour shift. Working B1 Crew. Weekends are included. Holidays included as the needs of the business warrant. Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

1. Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

2. Assist Operations by providing quality oversight and guidance for atypical events, assessing complex biologics manufacturing issues for forward processing.

3. Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas.

4. Supports return to service walkthroughs and Manufacturing audit readiness walkthroughs per procedures as needed.

5. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.

6. Reviews, approves and provides guidance for quality master data

7. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.

8. Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data

9. May support the Quality approval of Master Batch Records.

10. Supports the Quality review and closure manufacturing deviations.

11. Other duties as assigned.

Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 6-10years of relevant experience in a regulated environment with 2-4 years focused on product quality preferred. Demonstrated ability to independently assess complex manufacturing and automation issues. Knowledge of biotech cell culture, protein purification, bulk and finished product manufacturing is required. Knowledge of US and EU cGMP regulations and guidance. Knowledge of manufacturing batch record execution and review, maintenance execution approval, inventory management, and deviation management and approval is desirable.