At
Safecor Health, we are dedicated to improving patient safety and supporting hospital pharmacy operations nationwide. As the industry leader in pharmaceutical unit-dose packaging, we live our core values every day—
Care for our people and customers,
Commitment to doing what’s right, and a pursuit of
Excellence in everything we do.
Position Summary
The Quality Systems Audit Specialist performs audit reviews of packaging batch records prior to finished lot release for distribution, as well as Qualification and Stability packaging records. This position also supports record retention processes, audit trail reviews, documentation control, and continuous improvement initiatives to maintain a strong state of GxP compliance across the site.
The ideal candidate is highly organized, quality-focused, and committed to accuracy, compliance, and operational excellence.
Key Responsibilities
Quality & Compliance
- Follow all applicable Standard Operating Procedures (SOPs), Work Instructions (WI), cGMP requirements, OSHA guidelines, and regulatory standards.
- Review, recommend, and revise SOPs and Work Instructions as needed.
- Support SafeCor’s Culture of Quality through accountability, accuracy, and compliance-focused decision making.
Batch Record & Audit Review
- Perform audit reviews of completed Packaging Batch Records in accordance with approved procedures.
- Review Stability and Qualification packaging records for completeness and compliance.
- Review audit trails in:
- Optel Line Master
- Vision Systems
- Thermoformer systems
- Document observations identified during reviews and verify corrective responses have been completed appropriately.
- Support batch release activities by ensuring all documentation is accurate, complete, and compliant.
Documentation & Record Retention
- Maintain Packaging Batch Records and Master Folders in accordance with document retention procedures.
- File and maintain current and obsolete specifications for products, components, and supplies.
- Issue Packaging Batch Records upon request and ensure proper return and control of documents.
- Verify true copies of Master Production Records and Master Tool Set Up documents.
Systems & Administrative Support
- Assist with updates to Specification Indexes and controlled document distribution.
- Support preparation of Annual Product Review (APR) data related to batch release and specifications.
- Verify Learning Management System (LMS) data entries as assigned.
Continuous Improvement & Collaboration
- Participate in site improvement initiatives focused on process efficiency, waste reduction, and compliance enhancement.
- Work collaboratively with cross-functional teams to support operational and quality objectives.
- Contribute to continuous improvement efforts that strengthen quality systems and business performance.
Qualifications
Required
- High School diploma, GED, or equivalent
- 1–2 years of auditing or quality systems experience
- Knowledge of pharmaceutical industry standards and documentation practices
- Strong attention to detail and organizational skills
- Proficient computer skills and ability to manage electronic documentation systems
- Effective oral and written communication skills
Preferred
- Some college coursework in a related field
- Experience with cGMP documentation review and audit trail analysis
- Familiarity with Optel Line Master, Vision Systems, or Learning Management Systems
Skills & Competencies
- Strong documentation and process auditing abilities
- Ability to interpret and follow detailed procedures
- Analytical problem-solving and reasoning skills
- Ability to work independently while collaborating effectively with teams
- Commitment to integrity, accountability, and continuous improvement
Physical Requirements
- Primarily sedentary office-based work
- Frequent computer use and repetitive typing
- Ability to intermittently stand, walk, bend, stoop, kneel, and climb stairs
- Occasional lifting or moving of light materials; infrequent lifting up to 25–50 lbs.
Work Environment
This position operates primarily in a professional office environment with occasional interaction in manufacturing or production areas. Employees may work independently or closely with cross-functional teams in support of quality operations.
Benefits
- Clean and safe work environment
- Medical, dental and vision insurance
- Company-paid life insurance
- Health savings account
- Paid time off (PTO)
- Holiday pay
- Weekly pay
- 401k
- Opportunities for internal promotion
- Monthly employee appreciation meals
