Overview
Quality Engineer Jobs in Worcester, MA at The Fountain Group
Title: Quality Engineer
Company: The Fountain Group
Location: Worcester, MA
100% ONSITE WORCESTER MA
Pay: $63 – $68/HR
REQUIRED:
BS Degree in Bioengineering, Biomedical Engineering, Biological Engineering, Biotechnology, Pharmaceutical Sciences etc and 5+ years relevant experience in pharmaceutical/biologics manufacturing
PPQ: process qualification PPQ support and review activities on range of topics from process controls to raw material controls.
Quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. T
Product QA, Manufacturing QA, Supplier/Incoming QA, Process Qualification/Validation, Compendia management and CAPA.
Ability to ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with local, Corporate, and governmental regulations.
Job Description:
Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products. Assist project teams in planning, preparation, review and approval of quality documentation. Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures. Apply effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits. Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs. Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates. Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
