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Quality Specialist I

hace 1 mes

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Warehouse

**Responsibilities**:

- Verify and ensure operational processes at FCS Argentina facilities, encompassing reception, storage, preparation, packing of shipments, return, secondary conditioning, reconciliation, destruction, and inventories of medicines and clinical supplies. Ensure flawless communication between Operations, Customer Services, Quality Assurance, and other departments. Successfully meet deadlines and complete supporting documentation for all associated tasks.
- Perform physical inspection, verify related documentation, and strictly control the release of incoming drug/material receipts entering the warehouse in the operational management computer system(s).
- Complete pre, during, and post controls in secondary packaging processes (labeled/relabeled/other) to ensure world-class standards.
- Control the rejection process of medicines/materials by verifying movements, quantities, and corresponding documentation to determine accuracy.
- Generate necessary reports or documentation related to the verification and execution of the different processes.
- Verify and approve records and reports showcasing the accurate performance of GxP building maintenance and in-process controls. Adhere to timelines in approved site Work Plans or Schedules.
- Participate in the detection, prevention, and reporting of deviations and non-conformities related to warehouse operational processes. Actively engage in investigations of deviations, providing truthful information.
- Successfully implement corrective/preventive actions for deviations/customer complaints/observations found during customer audits, self-inspections, or regulatory inspections.
- Contribute to the design and review of existing and new processes for continuous improvement and aid in drafting and training of approved procedures and instructions.
- Support the preparation, review, execution, and documentation of Qualification, Validation, and Thermal Mapping processes of GxP areas and equipment.
- Assist in the preparation of Area Reports and Metrics.
- Ensure that industry records are filed in a secure and orderly manner.
- Align with company quality policies based on good manufacturing, distribution, documentation, and clinical practices, as well as regulatory and customer requirements.
- Perform all activities in an efficient and safe manner.
- Assist in other tasks as necessary to meet Area and business requirements.

**Job Requirements**:

- Bachelor's degree in Engineering or related field, or equivalent experience (graduated or in process)
- Proven experience in quality assurance within a GxP environment.
- Availability to work evening shift (Monday to Thursday 1:00pm to 10:00pm and Friday 1:00pm to 8:00pm)
- Intermediate English
- Outstanding attention to detail and strong analytical skills.
- Ability to compete and thrive in a fast-paced, ambitious team environment.
- Excellent communication and teamwork skills.
- Ability to strictly adhere to deadlines and regulatory requirements.
- Proficiency in operational management computer systems.