ProStaff Workforce Solutions is seeking a Compliance Associate for one of the largest pharmaceutical companies in Billerica, MA. Our client is one of the leading pharmaceutical companies in the region and specializes in the production and sale of radiopharmaceuticals and formulation, analytical methods development and production of parenteral drugs. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.
Full-time Onsite Contract
Job Summary:
The Temporary- Associate Compliance provides support in the evaluation and investigation of product quality complaints.Ensures compliance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and Quality Management System Standard Operating Procedures related to product complaint handling.
Area Of Responsibility
Support and assist the QA Complaint Coordinator and the QA Compliance Head on the evaluation and investigation of product quality complaints.
Work directly on technical investigations relating to Product Quality Complaints.
Document the evaluation and investigation of Product Quality Complaints within the Trackwise system.
Other duties as assigned
Qualifications
BS in a scientific field a plus
Minimum 2-4 years related experience in a pharmaceutical/medical device manufacturing regulated environment
Working knowledge of cGMPs (current Good Manufacturing Practices) and GDP’s (Good Documentation Practices)
Strong working knowledge of MS Word software
Must have exceptional writing skills to document the evaluation and investigation processes completed.
Experience evaluating and investigating drug/device product complaints
Experience using Trackwise, Veeva or QMS
Superior internal customer service/people skills
Ability to manage multiple responsibilities in a fast-paced environment, while performing in an efficient manner
About ProStaff Workforce Solutions We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts—many hailing from larger agencies—who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates.