No Relocation Assistance Offered
Job Number #175591 - Hodges, South Carolina, United States
Compliance SpecialistAs a Compliance Specialist you will be responsible for executing activities that support the site Quality Systems to ensure compliance with established Global Quality Standards and regulatory requirements. You will drive core operational workflows across Internal Auditing, Consumer Complaint Management, Management of Change, Annual Stability submissions, and Product Release processes. You will work within a structure that requires considerable interface with Making, Planning, Finishing and the 3PL Warehouse Team. This position will report to the Compliance Lead.
Responsibilities include, but not limited to:
- Lead internal auditing program and participate in Corporate Internal audits, Mock FDA audits, Operational Excellence Sweeps and Self-Assessments
- Manage and investigate Consumer Complaints and generate monthly KPI(s) to monitor product concerns
- Coordinate and lead Management of Change Program
- Performs product release using 6-Stream Quality Module in SAP
- Support management of documentation to comply with Global Quality Standards and regulatory requirements
- Provide training to colleagues as needed and support the maintenance of colleague training records
- Compile, analyze, and report data for KPI(s) based on Global KPI requirements and site requirements
- Participate in external audits to fulfill requests and ensure compliance with the regulatory requirements
- Execute, generate, and manage product registrations, Certificates of Analysis, and regulatory documentation for both US and Exports
Required Qualifications:- Bachelor's Degree
- Minimum 3 years of experience in Quality / Compliance within a GMP production environment
- SAP Experience or any other similar ERP system
Preferred Qualifications:- CQA Certification
- Experience analyzing statistical quality data using statistical tools such as Minitab
- Consumer Complaints experience
- Strong interpersonal capabilities with a data-driven approach to cross-functional collaboration and problem-solving.
Compensation and BenefitsSalary Range $76,800.00 - $107,500.00 USD
Pay is determined based on experience, qualifications, and location. Salaried employees may also be eligible for discretionary bonuses, profit-sharing, and long-term incentives for Executive-level roles.
Benefits: Salaried employees enjoy a comprehensive benefits package, including medical, dental, vision, basic life insurance, paid parental leave, disability coverage, and participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements. Additional benefits include a minimum of 15 vacation/PTO days (hourly employees receive a minimum of 120 hours) and 13 paid holidays (vacation days are prorated based on the employee's hire date within the calendar year). Paid sick leave is adjusted based on role and location in accordance with local laws. Detailed information regarding paid sick leave entitlements will be provided to employees upon hiring and may be subject to adjustments based on changes in legislation or company policies.
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