Batch Record Review Specialist
Raleigh Metro Area, NC
Manufacturing and packaging batch records for compliance with all applicable internal procedures and policies and state and federal regulations. Perform review of each batch record and certificate of analysis for accurate and completeness of data. Provides batch disposition to QA Management.
In addition to successful performing all tasks required for review and release of outside vendor products.
Provides disposition for quality issues identified and the appropriateness of action(s) taken for resolution in relation to manufacturing and packaging record documentation issues
Provides QA Management with finished product disposition (reject/release). Conducts reviews of development batches. Is responsible for finished product release when necessary.
May be involved in special assignments and higher level quality activities as needed.
Assures control of finished products prior to FDA approval. Audits product record files for all manufacturing and packaging records
Demonstrated ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position.
Develops training material and trains manufacturing and packaging personnel on Batch Record documentation.
Applies advanced concepts and techniques while performing the most complex or sensitive tasks of the position.
Interacts with other departments to resolve documentation issues.
Performs other duties as assigned.
Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E etc.)
4-6 years Batch Record Review experience