Compliance Analyst Job Description
This is a temporary 12-month contract role as a Temp Associate / Sr Compliance Analyst within Supply Chain Management.
Responsibilities:
* Develop an effective compliance framework for all Supply Chain departments through policy and procedure development and implementation.
* Serve as liaison between Supply Chain and onsite quality and regulatory groups to address non-compliance issues.
* Facilitate reviews and revisions of SOPs, plans, and policies for Supply Chain departments.
* Provide support and assistance with document initiation, review, submission, and follow-up.
* Drive proactive compliance in Supply Chain teams through self-audits, knowledge transfer, and education.
* Ensure compliance with associated procedures through required documentation.
* Work with Subject Matter Experts to understand investigation scope and business need.
* Complete associated documentation and forms for change controls/investigations.
* Collaborate with other functional groups to assess impact and obtain necessary reviews/approvals.
* Perform investigations and resolutions of non-conformities in a timely manner, complying with Regeneron procedures and regulatory requirements.
* Lead/participate in the investigation process and write/review investigation reports.
* Ensure Corrective & Preventative Actions are implemented effectively.
* Identify recurring events and notify management accordingly.
* Keep team members informed of assigned work status.
* Manage Change Controls for Supply Chain and develop robust training programs.
Requirements:
* Bachelor's degree in Business, Supply Chain Management, or Science background (or equivalent combination of education/experience).
* 2 years of experience in a cGMP environment (or equivalent combination of education/experience).
* Excellent written and verbal communication skills.
* Strong analytical and organizational skills.
* Ability to prioritize, adapt to change, and build relationships with customers and internal stakeholders.
* Proficiency in MS Office, Excel, PowerPoint, and Database.