Sr. Customer Complaints Specialist

7/22/20

Langhorne, PA 18940

1012

FullTimeRegular

QA System Clerk

BASIC FUNCTION: The QA System Clerk ensures quality and compliance of the facility with applicable regulatory requirements.

JOB RESPONSIBILITIES:

  • Monitoring the site change control program, approving documentation, and tracking change controls to closure.
  • Administering the site investigation program, CAPA system and market complaints including documentation, assisting in the investigation of planned and unplanned deviations.
  • Participating and monitoring Return drug products.
  • Participating and monitoring of Recall products.
  • Writing investigation reports, tracking, and trending of all the investigations and complaints (ADEs and non ADEs).
  • Contact to customers and medical advisor related to complaints and investigations.
  • Generating the Quality Events Trend Reports.
  • Organizing and participating in the Quality council meetings.
  • Monitoring Vendor qualification, Quality agreements and vendor questioner. Tracking of internal and external audits.
  • Preparation and submission of the annual reports and adverse drug reports (ADR).
  • Assigning Product codes intermediates Item identification number, Equipment identification numbers, QA document numbers and Raw Material Identification codes.
  • Participating in the SOP preparation, training and make it effective.
  • Coordination with other departments in relation to forwarding the required information.

ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:

  • Assist with development/writing of SOPs or other quality documents and/or reports as needed.
  • Effectively performs a variety of duties, on schedule, with accuracy and competency.
  • Serves as an effective member of the Quality team and may serve as a team trainer to other Quality employees.
  • Complies with company polices and SOPs.
  • High School degree or equivalent required, AS or BS degree preferred.
  • Minimum of 2 years of experience in the Pharmaceutical industry
  • Good written and oral communication skills
  • Excellent interpersonal, verbal and written communication skills
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