Job Details

  • Title: Quality Specialist
  • Code: RCI-53605
  • Location: Lititz Pennsylvania (PA) 17543
  • Posted Date: 01/14/2020
  • Duration: 11 Months
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  Job Description

? Apply quality assurance processes, procedures, and activities.
? Documentation is clear and grammatically correct in accordance with GMP and site procedures
? Perform quality review of production records including manufacturing, packaging, and laboratory documents.
? Review compliance records, specifications, procedures and other documents, as required.
? Assists in document preparation for regulatory agency visits and Corporate/internal audits.
? Prepare and send certificates of analysis for foreign affiliates
? Review batch records for complaint investigations
? File completed batch records appropriately
? Responsible for quality releases of finished product based on conformance to established standards
? Under direction from management, participate in continuous improvement projects.
? Report improvements to management
? Other tasks as determined by management
? Ensure quality and compliance in all my actions by:

a. Attend GMP training on the schedule designated for my role and as appropriate for my role.
b. Adhere to strict compliance with procedures applicable to my role.
c. Exercise the highest level of integrity in the tasks that I perform.
d. In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
e. Embrace a behavior of employee involvement and commitment to doing the job right the first time.

Support batch record release team by reviewing/compiling supporting documentation and preparation of foreign affiliates certificates of analysis (60%)
Review compliance records, specifications, procedures and other documents, as required by procedure. (20%)
Review batch records for complaint investigations (20%)