Quality Operations Specialist

Responsibilities

• Enter and track Training Records in the Quality Learning Management System.
• Maintain Supplier Lists
• Create and manage labels for all Safecor Health business segments.
• Facilitate end of day processes for documentation filing and QAD updates.
• Track and document control substance samples and DEA 222 forms management.
• Manage ARCOS quarterly report.
• Participate in the investigation and writing of unplanned deviations and incidents with Operations.
• Responsible for assigned Quality Audit execution, data assembly and report writing.
• Participate in performing segments of incoming inspections for repackaging components or drugs.
• Responsible for final quality check of delineated repackaging formats.
• Responsible for timely and concise communication with customers.
• Perform In-process quality checks and final inspection on commercial lots.
• Complete daily and monthly control retain sample audit.
• Help facilitate quarterly, end of year, and ad hoc basis destruction of Rx and OTC drugs.
• 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.
• Communicate effectively and thoroughly to management and peers any results or inspection findings outside of specifications.

Qualifications

• Bachelor’s degree required in Science-related discipline.
• 3 years of experience in the pharmaceutical industry.
• Quality experience within an FDA facility.
• Experience and knowledge of repackaging medications.

Skills

• General knowledge of medications and regulations for controlled substances.
• Training capabilities, including preparing material and presenting to small groups.
• Specific vision abilities required by this job include 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.
• Able to develop and maintain positive relationships with employees, officials, regulatory agencies, and other stakeholders.
• 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.
• Creates an inclusive environment where feedback, ideas, and perspectives are welcomed and encouraged.