Sr. Customer Complaints Specialist
Langhorne, PA 18940
QA System Clerk
BASIC FUNCTION: The QA System Clerk ensures quality and compliance of the facility with applicable regulatory requirements.
- 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