QUALITY ASSURANCE RELEASE SPECIALIST

Primary Responsibility:

• Accountable for providing operational and GMP compliance knowledge to support the manufacturing operations.
• Responsible for the execution and completion of investigation task items related to customer complaints and corresponding Corrective Action Preventive Action (CAPA's).
• Responsible for technical assistance in identifying, recommending and implementing process and equipment modifications to improve process performance.
• Identify and assist in the implementation of cost reduction projects and assure the manufacturing area is in cGMP's compliance.
• Responsible for quality auditor functions to support manufacturing operations.
• Responsible for providing QA support to process validation activities.
• Position has the authority to shut down a manufacturing area and have the product reworked if it is found out of compliance with GMP's and applicable procedures and specifications.
• Review and approve laboratory testing data, release documentation of raw materials, cleaning agents, labeling and packaging components.
• Verify and review final product release documentation including test results, QC data sheets, and Certificate of Analysis information.
• Review and approve laboratory documentation to support the USP/Ph Eur water system, stability program, and retention sample process.
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Essential Job Functions:

• Ensures that all investigations in the manufacturing and warehouse operations are carried out correctly in order to identify the root cause and assures any resulting Change Controls and CAPA's are completed / closed within the established timeframe, utilizing the right tools to prevent reoccurrence.
• Responsible for the investigating complaints and formulating a response for the complainant in a expedited manner. Coordinates proper corrective actions with operations to avoid recurrence of complaints.
• Participates in the new product introduction process to determine requirements for documentation, materials, training, equipment modifications, and document revisions.
• Conducts routine scheduled inspections of equipment and personnel in plant areas to ensure cGMP compliance. If discrepancies in cGMP, procedures, systems and techniques are observed an Auditor initiates an area inspection report, documents the incident, forwards the report to the department manager, and the facility supervisor.
• Monitors all work in process for proper use of materials, correct recordings and possible sources of cross-contamination and reports all deviations to the facility supervisor.
• Collects samples, as called for by protocol requirements, to assist with validation sampling as appropriate.
• Reviews product manufacturing records and analytical physical results to assure that all product requirements have been met prior to shipment from the appropriate processing facility.
• Assists with generation and execution of validation protocols and reports.
• Participates in regulatory inspections when necessary.
• Supports all site initiatives and any other assignments based on business needs.