Compliance Specialist I
About The Position
TheCompliance Specialistis responsible for maintaining regulatory compliance and quality standards within the manufacturing environment. This role manages a variety of compliance activities, including but not limited to Environmental Monitoring Investigation Reports (EMIRs), Environmental Deviation Reports (EDRs), TrackWise deviations, investigation tasks, and area documentation. The specialist ensures that investigations, corrective actions, and related tasks are completed accurately, on time, and in alignment with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and established Service Level Agreements (SLAs). In addition to managing documentation and investigations, the Compliance Specialist partners closely with area specialists, training specialists, and cross-functional teams to support compliance initiatives, promote audit readiness, and identify opportunities for process improvement. This position requires strong attention to detail, organizational skills, and a proactive approach to driving compliance across the department, ultimately ensuring product quality, regulatory alignment, and patient safety.
Requirements
- High School Diploma or Equivalent required
- 2 years manufacturing experience required
- Working knowledge in Microsoft Word, Excel and PowerPoint required
- SAP experience required
- Trackwise and MasterControl experience required
- Respirator Clearance Required
Nice To Haves
- Associate or Bachelor degree desired
- Leadership experience desired
- Pharmaceutical manufacturing experience desired
Responsibilities
- Prepare and manage Environmental Monitoring Investigation Reports (EMIRs), Environmental Deviation Reports (EDRs), TrackWise deviations, and investigation tasks in alignment with quality and regulatory requirements
- Ensure timely completion of investigations, root cause analyses, and corrective/preventive actions (CAPAs) to meet established Service Level Agreements (SLAs)
- Maintain area documentation and records to ensure compliance with GMP, SOPs, and applicable regulatory standards
- Partner with area specialists, training specialists, and cross-functional teams to support compliance initiatives
- Provide manufacturing support when required
- Identify and recommend process improvements to strengthen compliance practices and drive efficiency
- Support audit readiness by ensuring accurate, complete, and well-maintained documentation and records
- Perform additional compliance-related tasks and responsibilities as assigned
Benefits
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Chemical Manufacturing
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
