Roles & Responsibilities:
Performs work under general supervision.
Provide quality, technical support and oversight during manufacturing activities.
Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
Review and evaluate QC testing records and any associated OOS investigations.
Review, write, revise, and approve SOP's, technical documents, and reports.
Perform inspection and release of materials used for production and review vendor certificates for completeness / compliance against approved spe...