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Scientific. Clinical. Software Engineering

Senior QA Associate

Fort Worth Metro Area, TX

Job Type: Scientific Job Number: JN -042020-26753 Region: Fort Worth Metro Area

Job Description

Duties:

Review/Write/Revise Standard Operating Procedures, Forms and other relevant documentation related to departmental activities

Enhance MBR review process

Provide necessary incoming material inspection and release activities

Facilitate sit training activities/training administrative tasks along with other QA tasks deemed necessary

Works with functional departments in collecting data trends of critical operations within these departments to generate trending reports for cross functional review and to update management of various department on GMP Compliance status

Supports preparation and maintenance of inspection readiness

May participate in internal and external audits and work with vendors / internal departments to evaluate and ensure that appropriate responses to audit observations are received and closed in a timely.

Handles and tracks audit corrective actions and works with departments on completing them on time

Skills:

A minimum of 5-7 years in a global pharmaceutical manufacturing environment with exposure to Quality Assurance, Quality Control, Manufacturing, Facilities, IT and Supply Chain

Knowledge of cGMP and ability to organize and implement cGMP procedures based on regulatory / compliance regulations

Experience in regulatory inspections / Experience in Pharmaceutical experience


Education:

BA/BS in scientific discipline required or equivalent work experience

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