Paga 18.72 p/h debe tener experiencia en Batch Records y Quality Minimo asociado o educacion en ciencias

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 :

• Review and audit the batch records for production areas. The audit process includes checking materialconsumption, 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 tobusiness needs.
• Identify and address timely correction of discrepancies observed during the batch record review followingcGMPs and documentation practices. The auditor is responsible for evaluating the discrepancies and tocontact 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 :

• 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)