Temporary QA Manufacturing Associate (21-01126)
Job Description
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. Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.
3. Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
4. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.
5. Reviews, approves and provides guidance for quality master data
6. Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
7. 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.
8. Assist Operations by providing quality oversight and guidance for atypical events.
9. May provide guidance to less experienced staff.
10. May support the Quality approval of Master Batch Records.
11. Supports the Quality review and closure manufacturing deviations.
12. May support release of incoming or manufactured products.
13. 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 4 years of relevant experience in a regulated environment with 2 years focused on product quality preferred
• 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.
Additional Job Requirements:
None
How to Apply
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