Specialist, Quality Operations
On-siteColumbus, Ohio, United States
Job Summary
Manage drug labels, update systems, and perform in-process and final quality checks on commercial lots for Safecor Health's repackaging segments. Enter training records, maintain supplier lists, and document control substance samples while facilitating audits, deviations, and incident reports. Conduct incoming inspections, manage DEA 222 forms, and assist in drug destruction cycles. Communicate inspection findings to management and collaborate with operations to ensure compliance with current Good Manufacturing Practices. Requires a science-related bachelor's degree, three years of pharmaceutical experience, and close attention to detail.
Required Qualifications
- Bachelor's degree in Science-related discipline
- 3 years of experience in the pharmaceutical industry
- Quality experience within an FDA facility
- Experience and knowledge of repackaging medications
- General knowledge of medications and regulations for controlled substances
- Specific vision abilities including close vision, distance vision, color vision and depth perception with or without corrective devices and / or supports
- Ability to lift up to 30 lbs. as needed
- Ability to read, speak and write in English
- Self-directed individual with strong attention to detail and good organizational skills
- Ability to work collaboratively across groups to support business goals
- Able to effectively manage competing priorities based on rapidly evolving business and employee needs
- Familiar with SharePoint and MS apps including Word, Excel, and PowerPoint
- Excellent attendance and reliability
- Strong, positive communicator (verbal and written) and collaborator
- Demonstrates strong emotional intelligence and self-awareness
- Demonstrates credibility, self-determination and a sense of ownership and urgency in their responsibilities
- Shows curiosity; learns and adapts with the organization, and willingly shares knowledge to positively influence the company goals
- Learns and adapts with the organization
- Creates an inclusive environment where feedback, ideas, and perspectives are welcomed and encouraged
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