Actalent Senior Associate Compliance in Bedford, Massachusetts
The Sr. Associate Compliance provides scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
• Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
• Work directly on technical investigations relating to Product Quality Complaints
• Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries
• Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
• Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
• Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
• Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
• Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable
• Manage electronic Quality Management System (TrackWise)
• Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
• Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
• Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
• Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs
• Author/revise standard operating procedures (SOPs) and test methods, as required
• Handle and implement quality systems like eQMS, EDMS, and LMS
Manage QMS (Quality Management System
Author and revise SOPs
Run stage II OOS Investigations
Additional Skills & Qualifications:
6-8 years of experience
Working with chemistry (wet chemistry)
Working with radio pharmaceuticals
Handling QMS systems and using trackwise
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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