Specialist, Quality Operations

Safecor Health; Columbus (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Safecor Health in Columbus, OH is seeking a Quality Specialist to oversee drug labeling, QA reviews and inspections ensuring GMP compliance across repackaging and distribution.

You will manage training records, supplier lists and inspections, coordinate audits, deviations, incidents and training, and support quality activities with operations to uphold quality standards.

Qualifications

• Bachelor's degree in a science-related field is required.
• At least 3 years in the pharmaceutical industry.
• Experience in FDA-regulated environments is required.
• Experience with repackaging medications is preferred.

Responsibilities

• Enter and track Training Records in the Quality Learning Management System.
• Maintain Supplier Lists.
• Create and manage labels for all Safecor Health segments.
• Facilitate end-of-day documentation filing and QAD updates.
• Track and document controlled substance samples and DEA 222 forms.
• Manage ARCOS quarterly report.
• Investigate deviations and incidents with Operations.
• Assist in quality audits and report writing.
• Conduct incoming inspections for repackaging components or drugs.
• Perform final quality checks on delineated repackaging formats.
• Communicate results and inspection findings to management.
• Conduct in-process quality checks and final inspections on lots.
• Complete daily/monthly control retain sample audits.
• Assist with destruction of Rx and OTC drugs.
• Contact drug manufacturers for information.
• Inspect finished products and facilities for GMP compliance.
• Communicate clearly with stakeholders about quality findings.

Skills

Attention to detail

Communication

English proficiency

Collaboration

Regulatory knowledge

Education

Bachelor's degree in Science-related discipline

Tools

SharePoint

MS Office

QAD

Job description

Job Details

Job Location: Columbus OH - Columbus, OH 43204

The Quality Specialist will add and update drugs into the system, create new and revised labels for all segments of Safecor Health's businesses, participate in the in-process or final quality review of specific service segments and supporting processes, participate in control substances inventory management and documentation, and participate in quality assurance activities including facilitation of audits, deviations, incident reports and training. Supports quality in standard processes to ensure compliance with standards; works with operation staff to ensure inspection procedures are implemented and maintained; assists in the development of standards to meet quality specifications: quality oversight during production.

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.

Education & Experience

• 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.

Knowledge, Skills & Abilities

• 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.

Competencies

• 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.
• Learns and adapts with the organization.
• Creates an inclusive environment where feedback, ideas, and perspectives are welcomed and encouraged.