What are the responsibilities and job description for the Change Control Compliance Specialist position at HTi LLC?
HTI is seeking a Change Control Compliance Specialist for PAI Pharma, a large manufacturer of prescription and OTC pharmaceuticals. Leveraging cutting-edge technology to produce the best-in-class suspensions and oral solutions, this manufacturer has been recognized for being a leader in innovation, quality, and safety. Understanding it is their employees who make the true impact, this organization is known for their commitment to being an employer of choice - offering competitive pay, benefits, and a positive environment for employees at any level!
What They Offer :
- Full benefits package - Medical, Dental, Vision, EAP, 401k Match
- Onsite Wellness Center
- Tuition Reimbursement
- 13 Paid Holidays
- Progressive PTO Plan
What You Need :
What Your Role Will Look Like :
The Change Control Compliance Specialist will serve as a Subject Matter Expert in managing the Quality Systems Change Control Program. This includes preparing and coordinating change control documentation, ensuring compliance with FDA and cGMP standards, and driving continuous improvement initiatives across the organization. This role requires interfacing with cross-functional teams to achieve timely and accurate execution of changes.
