Merck KGaA Norristown, PA

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Specialist, Quality Assurance

Your Role

Ensure that all aspects of product and service meet quality standards/ expectations. Support the maintenance, development and improvement of the quality management system supporting site operations and ISO accreditations as well as other customer and/or regulatory requirements. These systems would include auditing (internal, external, and vendor), training/employee development, validation, change control, customer complaint investigation, document control.

In this role you will review completed batch records for compliance; initiate and coordinate the Management of Change for product quality-related changes to documents, equipment, specs, and methods; participate in the internal/supplier auditing programs; issue reports after supplier audits; Maintain database for customer audits, issue corrective actions, follow-up for effectiveness checks.

Represent the company during customer/external audits, Monitor and trend results for critical quality processes, customer complaints, pass rates, etc. Respond to quality related customer complaints/questions, and maintain customer ratings regarding quality.

Write and/or review documentation to ensure compliance to all standards or regulations; coordinate Validation activities; assist with oversight of calibration department; interact with the production and laboratory personnel frequently to ensure adequate communication and feed back for quality related services to internal customers. Lead and participate in root cause and risk assessment activities related to process and product investigations and improvements.

You will also participate in Quality Training/Employee development; review and manage customer requests for product agreements and change control; maintain the quality actions and look for trends; lead and participate in process improvement projects related to the document control process for quality management system to gain efficiencies and to ensure effectiveness in supporting company quality goals. Maintain and continuous improvement of department metrics.

Physical Requirements:

Hearing and vision within normal limits.

Ability to use PC frequently.

Who You Are:

Minimum Qualifications:

Education: BS degree in Chemistry or related science, or Quality Assurance.

2+ years quality experience

1+ years of experience working on or leading process improvement projects

Preferred Qualifications:

Knowledge of ISO quality management system

Excellent interpersonal skills

Excellent problem solving skills

Ability to prioritize and organize

Good computer skills (advanced user of excel and word and relevant databases a plus)

Exceptional ability to learn and apply new concepts

ADDITIONAL LOCAL NEEDS

Office and laboratory environment.

RSRMS

Associated topics: prevent, prevention, quality, quality assurance analyst, quality assurance lead, software quality assurance, software quality engineer, software quality assurance engineer, test, test engineer

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