Customer Compliant Specialist

Proclinical is currently recruiting for a Customer Compliant Specialist with a pharmaceutical company located in Cambridge, MA.

Job Responsibilities:

• Manage and document complaint records while ensuring they are processed in a uniform and timely manner.
• Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP).
• Responsible for assuring all product quality complaints are appropriately initiated in the Veeva Quality Management System (QMS).
• Interface with Medical Information Call Center to obtain information regarding product feedback and complaints.
• When necessary, call and/or write the complainant to obtain additional information such as lot number and expiry date.
• Prepare customer communication (response letters, acknowledgement letters) as appropriate.
• Provide metrics on post market data.
• Participates in Customer Service and process improvement initiatives.
• Perform other duties as requested by management.

Skills and Requirements:

• Bachelor's Degree, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.
• At least 2-5 years' experience in Quality Assurance / Quality Systems in a current Good Manufacturing Practices (cGMP) role.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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