Quality Specialist - Operation Support

BD

78d

About The Position

This position is responsible for the Quality Incoming sampling and physical inspection of raw materials and components in accordance with approved drawings and specifications and contributes in the maintenance of records on vendor performance. Performs evaluation of Device History Records for completeness and compliance to specifications during manufacturing processes and prior to final product release as needed. Performs usage decisions in SAP for Raw Materials, In-process and Finished Goods. Verify that line clearance is performed after manufacturing and packaging activities. Actively participates on the analysis and resolution of supplier quality problems. Ensures that work performed conforms to QSR, ISO and OSHA standards and regulations.

Requirements

• Knowledge of current regulatory requirements for pharmaceutical/medical devices industry.
• Knowledge in material sampling techniques and use of applicable ANSI/ASQ sampling standards.
• Experience in Incoming Quality Assurance inspection and product disposition in SAP.
• Effective skills on analytical thinking, problem solving, interpersonal relationships, written and oral communication, planning/organization, and meeting’s development and participation.
• Computer literate (MS Windows and MS Office).
• Bilingual (English and Spanish).

Nice To Haves

• Preferred a Bachelor Degree in a related scientific discipline (such as Chemistry, Biochemistry, Microbiology, Biology, and Engineering) and a minimum of one (1) year of quality assurance/regulatory affairs experience in a pharmaceutical/medical device environment or equivalent combination of related education and experience.
• Or as a minimum an Associate Degree with five years of Quality Assurance experience in a pharmaceutical/medical device environment.

Responsibilities

• Responsible for the inspection and timely disposition of raw materials and packaging components, following approved procedures and specifications.
• Documents inspection performed in SAP system and required forms in a timely manner.
• Responsible for the timely disposition of In-Process material following approved procedures and specifications.
• Documents usage decision in SAP.
• Ensures that all testing and documentation of manufacturing data is complete and accurate.
• Responsible for the timely disposition of Finished Goods following approved procedures and specifications.
• Documents product disposition in SAP.
• Ensures that all testing and documentation of manufacturing data is complete and accurate.
• Assures that Quality Notifications for non-conforming materials are created, investigated, completed and closed in accordance to the established Standard Operating Procedures.
• Evaluate that line clearances are performed in a timely and effective manner per established standard operating procedures.
• Stays up to date on the fundamental requirements for alignment in own area of work and aligns with those requirements.
• Participates as required in training on regulatory issues affecting own area of work.
• Brings regulatory compliance questions/issues to the attention of management.
• Promotes a safe environment.
• May provide recommendations on maintaining the safety of the work environment.
• Participates in Environmental Health and Safety (EH&S) programs.
• Address corrective actions whenever a hazard is identified.
• Provide recommendations to support systems that continuously improve product/process quality and product availability, reduce cost, and increase production capability.
• Performs other related duties and assignments as required.

What This Job Offers

• Education Level: Bachelor's degree