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Quality associates support the development and implementation of programs to establish and maintain quality standards of existing products and services, as well as developing programs to focus employees on quality improvement. They support the development of policies, procedures, and methods to check product, material, components and/or operational quality and improve same. They are responsible for supporting the development and implementation of a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. The QA Technician is responsible for overseeing and maintaining the in-process and final inspection methods and processes. Recognizes process improvement opportunities and works with teams to implement changes. Drives both department and business objectives.
Job Responsibility:
Consistent application of Quality System standards to assigned area
Develops solutions to routine assigned activities of limited to moderate scope & complexity
Follows applicable Company / Unit procedures and may make updates to procedures and policies
Proactively manages group and/or personal metrics to ensure goals are tracked and met
Works within and across functions for assigned Quality systems
Monitors and plans daily workload in the most efficient/productive manner
Provides guidance to Manufacturing associates to ensure adherence to Quality System Procedures as needed
Communicates the need for standards and process compliance to members of functional area
Effectively collaborates with functional group
Communicates issues related to lack of resources to managers in a proactive manner
Initiates Nonconforming Material reports and/or Planned Deviations as needed
Participates in and contributes to continuous improvement initiatives
Prepares and distributes Quality Metrics related to the result of final inspection
Acts objectively in solving problems
Keeps manager informed of important changes/issues affecting Finished Product release or quality issues arising from the Mfg floor
Work cross-functionally to expedite urgent batches to FGI
Review and write procedures and SOP’s
Initiate ECRs as needed
Assist in troubleshooting inspection process-oriented problems
Assist in the development and evaluation of new processes and procedures
Analyzes existing processes and procedures to suggest continual improvements
Follows BD Biosciences Environmental, Health and Safety (EH&S) policies and procedures
Supports internal customers: Operations, R&D, Production Planning, Quality Engineers, and Logistics
Performs other related duties and assignments as required
Requirements:
High school diploma
Daily working knowledge of SAP
Computer skills required, such as Microsoft Word, Microsoft Excel and the use of email
Pharmaceutical, Biotech, Medical Device, Regulatory, or QA experience preferred
Limited / Basic application of Quality systems principles and concepts ( e.g. Document control, Complaint Mgt or other broad Quality Systems area)
Basic knowledge of ISO 9001, ISO 13485, and other applicable regulatory bodies
Limited/Basic application of Quality Systems principles and applicable Regulatory and/or Business requirements
Self-driven and detail oriented
Able to work independently and with minimal supervision
Demonstrated ability to perform detail-oriented work with high degree of accuracy
Effective time management skills
Ability to handle multiple tasks and meet deadlines
Effective organization, planning, and prioritization skills
Effective analytical and problem-solving skills
Effective written and oral communication skills
Effective interpersonal skills
Demonstrated ability to follow established policies and procedures
Must be able to lift 35 pounds
Must be able to work in different temperature environments (Ambient, 4C, -20C, -80C)
Local drive or transportation may be required between different BD Biosciences San Diego facilities
Nice to have:
Pharmaceutical, Biotech, Medical Device, Regulatory, or QA experience preferred