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.
INDCQA
.png)