Quality Assurance Floor Support Lead, 2nd Shift

Summary:

Provide Quality assistance and oversight during manufacturing of in-process intermediates and drug substance, and other GMP processes as required. Assists in the identification, generation and quality approval of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities:

• Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
• Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
• Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
• Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
• Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
• 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.
• Contributes to driving innovation through continuous improvement of quality processes as well as supporting manufacturing continuous improvement initiatives.
• May provide guidance to less experienced staff.
• Supports the Quality review and closure of manufacturing investigations.
• Other duties as assigned.

Knowledge/Skill:

• 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 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
• Knowledge of US and EU cGMP regulations and guidance.
• Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking and maintenance is desirable.