"Alerted.org

Position Summary

Responsible for ensuring compliance and following all regulations and quality systems within our international distribution centers. Perform time and temperature analysis for shipments within the US and LATAM distribution network. Responsible for creating quality events, obtaining dispositions, and product release for products at US distribution centers.

Primary Duties

+ Evaluate shipments using Time and Temperature out of Range (TTOR) and Mean Kinetic Temperature (MKT) principles.

+ Initiate quality events, liaise with manufacturing sites for dispositions and distribution centers for product release.

+ Execute assigned quality projects, with guidance from technical quality expert (depending on level of experience), using engineering principles, business standards, practices, procedures, and project requirements.

+ Assure proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.

+ Communicate the quality status of materials to internal customers, management, and external suppliers.

+ Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, OSHA, etc.).

+ Make recommendations for improving quality & productivity performance.

+ Contribute continuous product and process improvements in areas related to department.

+ Lead activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, etc.

+ Work with other departments to ensure operational and quality goals are understood and met.

+ Participate and communicate status, business issues, and significant developments in projects.

+ Develop and review procedures (both internal and external).

+ Perform all work in compliance with company quality procedures and standards.

+ Perform other duties as assigned.

Education

+ Bachelor’s degree in a scientific or technical field (biology, chemistry, engineering, statistics), including Pharmaceutical or Medical Device experience, or related field.

Qualifications

+ Minimum 2+ years of professional related experience in scientific or technical field (pharmaceuticals or clinical laboratory, biological, chemical, engineering, or statistical related fields).

+ Experience in data analysis, interpreting laboratory results, and working in a scientific setting.

+ Effective written and oral communication skills.

+ Competence in the selection and use of Quality Engineering tools, techniques, and processes.

+ Strong computer skills including Microsoft Office (Excel, Word, etc.).

+ Flexibility in responding to unexpected demands and ability to work in a team environment, building effective working relationships.

+ Knowledge of GMP, ISO, and FDA compliance.

Knowledge, Skills and Abilities

+ Critical thinking, adaptability, time management, communication, and problem-solving.

+ Technical learning aptitude to quickly acquire new knowledge and skills.

+ Ability to lead without authority through influence and guidance.

+ Effective problem analysis and decision-making.

+ Detail orientation and ability to manage competing deadlines.

+ Technical writing skills; knowledge of bioMérieux reagents and instruments preferred.

Working Conditions

+ Ability to ascend/descend stairs, ladders, ramps, and similar structures.

+ Ability to adjust or move objects up to 50 pounds in all directions.

+ Domestic travel required: approximately 10%.

+ International travel required: 0%.

+ Typical office setting, including sitting and typing; some warehouse tasks required.

#LI-US