Sr. Quality Engineer
West Pharmaceutical Services, Inc. Scottsdale
DUTIES: Review and approve product / process deviations or rework documentation. Provide quality reports and review trending on assigned areas of responsibility. Work with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and quality records including but not limited to nonconformance reports, issue reviews, deviation reports, corrective and preventive actions.
Participate in development and maintenance of product risk and hazard analysis in accordance with ISO 14971. Meet company and departmental goals in the continuous improvement of all products, services, and processes. Support quality assurance improvement activities by evaluating products, processes, or materials in order to develop control or improvement strategies intended to improve the customer's experience.
Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. May require to travel/telecommute.
REQUIREMENTS: Employer requires a Masters degree in Chemistry, Pharmacy or related technical field plus 6 months experience in job offered, Validation Engineer, Quality Analyst, related occupation. Experience must include: 1) Root Cause Analysis, 2) Risk Assessments, 3) Technical Documentation, 4) Validation/Qualification, 5) Change Controls, 6) Investigations, 7) Quality Assurance, and 8) FDA regulations that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.
WORKSITE: West Pharmaceutical Services, Inc., 14677 N 74th St, Scottsdale, AZ 85260.
CONTACT: Mail CV/Cov ltr: Attn: Juliana Davis, West Pharmaceutical Services, Inc. 530 Herman O West Drive, Exton, PA, 19341. Must use Job Code G7205-00087. EOE.
Participate in development and maintenance of product risk and hazard analysis in accordance with ISO 14971. Meet company and departmental goals in the continuous improvement of all products, services, and processes. Support quality assurance improvement activities by evaluating products, processes, or materials in order to develop control or improvement strategies intended to improve the customer's experience.
Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence. May require to travel/telecommute.
REQUIREMENTS: Employer requires a Masters degree in Chemistry, Pharmacy or related technical field plus 6 months experience in job offered, Validation Engineer, Quality Analyst, related occupation. Experience must include: 1) Root Cause Analysis, 2) Risk Assessments, 3) Technical Documentation, 4) Validation/Qualification, 5) Change Controls, 6) Investigations, 7) Quality Assurance, and 8) FDA regulations that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products.
WORKSITE: West Pharmaceutical Services, Inc., 14677 N 74th St, Scottsdale, AZ 85260.
CONTACT: Mail CV/Cov ltr: Attn: Juliana Davis, West Pharmaceutical Services, Inc. 530 Herman O West Drive, Exton, PA, 19341. Must use Job Code G7205-00087. EOE.
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