Quality Associate

Safecor Health • Columbus, OH

2d • Onsite

About The Position

At Safecor Health, we pride ourselves on creating a culture built on Care, Commitment, and Excellence. These core values guide every interaction, decision, and relationship within our organization. As we continue to grow, we are seeking a dedicated and experienced Quality Associate to join our dynamic team. In this role, you will be responsible for a variety of tasks related to quality assurance, documentation, training, and compliance within the pharmaceutical industry. You will work closely with multiple departments to ensure Safecor Health's high standards for quality, safety, and regulatory compliance are consistently met. This position is an exciting opportunity for someone passionate about quality assurance and pharmaceutical operations. The Quality Associate is responsible for ensuring that products and processes meet established quality standards and regulatory requirements. Days/Hours: Monday- Friday, 7:00am-3:30pm

Requirements

• Bachelor’s degree in a Science-related discipline.
• 3+ years of experience in the pharmaceutical industry.
• Quality experience within an FDA-regulated facility.
• Experience and knowledge of medication repackaging.
• General knowledge of medications and regulations for controlled substances.
• Strong training capabilities, including preparing material and presenting to small groups.
• Excellent attention to detail and organizational skills.
• Ability to lift up to 30 lbs as needed.
• Ability to read, speak, and write in English.
• Familiar with SharePoint and Microsoft Office apps, including Word, Excel, and PowerPoint.
• Strong communication skills, both verbal and written.
• Ability to manage competing priorities in a fast-paced environment.
• Self-directed and proactive with the ability to adapt to rapidly evolving business needs.
• Strong communication and collaboration skills, with the ability to develop positive relationships with employees, regulatory agencies, and stakeholders.
• Demonstrates emotional intelligence, self-awareness, and credibility.
• Strong sense of ownership and urgency in responsibilities.
• Continuous learner who adapts to change and shares knowledge to positively impact company goals.
• Fosters an inclusive environment where feedback, ideas, and diverse perspectives are encouraged.

Responsibilities

• Ensure compliance with industry regulations, standards, and internal quality procedures.
• Provide training and support regarding quality assurance practices and standards.
• Stay up to date with changes in industry regulations and best practices.
• Create and manage labels for all Safecor Health business segments.
• Facilitate end-of-day processes for documentation filing and QAD updates.
• Track and document controlled substance samples and manage DEA 222 forms.
• Investigate and document unplanned deviations and incidents in collaboration with Operations.
• Lead and execute Quality Audits, including data assembly and report writing.
• Participate in incoming inspections for repackaging components or drugs.
• Conduct final quality checks on delineated repackaging formats.
• Ensure timely communication with customers regarding quality-related issues.
• Perform in-process quality checks and final inspections on commercial lots.
• Conduct daily and monthly control retain sample audits.
• Facilitate the destruction of Rx and OTC drugs quarterly, at year-end, and as needed.
• Communicate effectively with management and peers about inspection results or deviations.
• Collaborate with drug manufacturers to obtain necessary product-related information.
• Monitor adherence to Good Manufacturing Practices (GMP) across all operations.
• Lead by example and embody Safecor Health’s Core Values of Care, Commitment, and Excellence in every aspect of your work.
• Enter and track Training Records in the Quality Learning Management System.
• Maintain Supplier Lists
• Manage ARCOS quarterly report.
• Participate in the investigation and writing of unplanned deviations and incidents with Operations.
• Contact drug manufacturers to obtain drug related information.
• Inspect finished products, supplies, equipment, personnel, and facilities for adherence to quality specifications, current Good Manufacturing Practices.

Benefits

• Be part of a supportive and inclusive company culture that values Care, Commitment, and Excellence.
• Opportunity to make a real impact on the organization’s success by being a part of a strong team and fostering a positive environment.
• A chance to grow your career in a dynamic and fast-growing company.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level