Greater Boston Area
Looking to elevate your career to the next level with an industry leading patient-focused biopharmaceutical company? A Top-10 pharmaceutical leader that focuses on developing and manufacturing world-class innovative medicines in Neuroscience, Oncology, and GI is currently seeking a Compliance Specialist as their company is rapidly expanding! This company has received recognition for their overall success and is looking to increase headcount within the Quality Department. Now is a pivotal time to get in with this group as you will have the ability to lead and impact their robust pipeline of promising new medicines.
- Lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, Assessment of event for impact to Safety, Identity, Strength, Quality & Purity (SISQP).
- Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance and leading of Risk Assessments, Causing Mapping, Interviewing.
- Routine interaction with the customer, including compilation of Power Points to communicate investigatory current status, Alignment meetings, facilitated reviews, Corrective and Preventative Actions (CAPA) discussions, Comments resolution.
- Mentoring and training of Deviation Investigator / Initiators Levels 1, 2, and 3. Provide investigation guidance and expertise for complex deviation investigations to the team, as well as to associated cross functional teams in order to drive to root cause of the events.
Ideal Candidate Must Have:
- Bachelor of Arts/Science or equivalent combination of education minimum. Preferred area of study: Biochemistry, Chemical Engineering, Biology or other relevant science discipline.
- Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting.
- Experience with investigations/equivalent. Advanced experience in the Pharma industry. Prior experience working in a manufacturing environment or troubleshooting manufacturing related issues and technical writing experience required.