Quality Systems and Compliance

Quality Systems and Compliance - Contract - Cambridge, MA

Proclinical is seeking a dedicated and detail-oriented individual for the role of Quality Systems and Compliance Specialist. This is a contract position located in Cambridge, MA.

Primary Responsibilities:

This role will primarily focus on managing product complaint handling and supporting regulatory inspection preparation. The successful candidate will also act as a document control back-up support. This is a hybrid role, offering both remote and onsite work flexibility.

Skills & Requirements:

• Experience in managing product complaints and/or adverse event process, intake, reconciliations.
• Familiarity with GxP regulations including product complaint handling, patient privacy principles, document control.
• Experience with Veeva QualityDocs and Veeva eQMS is a plus.

The Quality Systems and Compliance Specialist will:

• Manage product complaint handling, including intake from secured access mailbox, weekly and monthly reconciliations with vendors, partners, affiliates, and Drug Safety & Pharmacovigilance.
• Assist in providing product complaint metrics reports.
• Develop training on product complaint handling.
• Assist with revision of product complaint SOPs/WI.
• Archive product complaints in accordance with company policies.
• Act as a document control back-up support.
• Support regulatory inspection preparation and be onsite during inspections as required.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

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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