Location
Type
Status
Open
Devens, MA
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 products.
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.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Assist Operations by providing quality oversight and guidance for atypical events, and assessing complex biologics manufacturing issues for forwarding processing.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing audit 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.
Reviews approve and provide guidance for quality master data.
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.
May support the Quality approval of Master Batch Records.
Supports the Quality review and closure of manufacturing deviations.
Other duties as assigned.
Experience and Qualifications:
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 is preferred.
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 products.
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.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Assist Operations by providing quality oversight and guidance for atypical events, and assessing complex biologics manufacturing issues for forwarding processing.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing audit 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.
Reviews approve and provide guidance for quality master data.
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.
May support the Quality approval of Master Batch Records.
Supports the Quality review and closure of manufacturing deviations.
Other duties as assigned.
Experience and Qualifications:
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 is preferred.
Devens, MA
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 products.
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.
Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Assist Operations by providing quality oversight and guidance for atypical events, and assessing complex biologics manufacturing issues for forwarding processing.
Perform walkthroughs of GMP areas documenting observations and areas of concern to support audit readiness of the manufacturing facility and support areas.
Supports return to service walkthroughs and Manufacturing audit 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.
Reviews approve and provide guidance for quality master data.
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.
May support the Quality approval of Master Batch Records.
Supports the Quality review and closure of manufacturing deviations.
Other duties as assigned.
Experience and Qualifications:
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 is preferred.
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