Batch Auditor Technician

Description

Purpose :

• The Audit Technician reviews the batch records data from production areas to ensure the documentation complies with the Good Manufacturing Practices (cGMPs), documentation practices and applicable regulations.
• Maintain custody of batch records and supporting data audited in the document control area. Facilitate batch record documentation during internal and external inspections.
• The Audit Technician is responsible for the approval and release of manufactured/packaged products.

Responsibilities :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Review and audit the batch records for production areas. The audit process includes checking material consumption, environmental conditions, evaluation of critical parameters, cleaning, printed material usage, expiration dates.
• The review and audit may be conducted at the production areas on-line based according to business needs.
• Identify and address timely correction of discrepancies observed during the batch record review following cGMPs and documentation practices.
• The auditor is responsible for evaluating the discrepancies and to contact the SME for resolution.
• Evaluate and approve the exceptions generated during the manufacturing and/or packaging process.
• Also, responsible for obtaining the supporting data to approve and close Hold documents.
• Provide final disposition of drug products, components, raw materials, and finish products as applicable.
• Create or verify certificates of analysis, compliance or manufacture for products as required.
• Keep manual or electronic tracking of documents processed and those pending review. Be the custodian for documents in a controlled area and facilitate internal or external requests. Prepare applicable documentation packages for record retention.
• Has the knowledge and utilize electronic systems to review inventory transactions and provide disposition (e.g. SAP), exception documents (e.g. Soltraqs), and electronic manufacturing batch records (e.g. POMsNet) among others.
• Generate and provide reports to area supervisor or management upon request. File batch record documentation after receiving and/or approval and generate the associated documentation of this process.
• Responsible for performing tasks assigned based on identified business area needs.
• May be required to perform quality control inspections, verifications and documentation review for manufacturing or finishing areas as required.

Qualifications :

• List required and preferred qualifications up to 10). Include education, skills and experience.
• Associate Degree – Science or Business Administration
• 4 years minimum experience in Quality Control in a pharma related industry. 3 year experience in batch records audit (preferred)
• Knowledge of GMPs, DEA controlled substances handling (preferred)
• Able to perform basic math operations and to handle documentation using electronic systems
• Good verbal and written communication skills (English and Spanish)