Quality Assurance & Compliance Specialist

• Support the cGMP compliant quality program for pharmaceutical storage

• Work in collaboration with Emergency Preparedness and Response Manager, Operations Manager, Program Manager, and Compliance Manager

• Maintain and enhance the quality management system (Master Control)

• Ensure consistent quality practices across all distribution operations

• Serve as a functional member of the Quality team to manage Master Control, including document control, training, change control, and other cGMP workflows

• Participate in the development, maintenance, and documentation of policies, procedures, and work instructions within the Quality Management Program

• Schedule, participate in, and review internal quality audits and related meetings

• Support external audits with customers, regulatory bodies, and third-party auditors and track audit findings with assisting in timely implementation and verification of corrective actions

• Serve as the internal point of contact for documenting and tracking ongoing performance issues

• Support root cause analysis efforts to help develop effective corrective and preventive actions (CAPA)

• Act as liaison with customers and vendors regarding quality issues, investigations, and corrective actions

• Conduct vendor qualification activities and review annual vendor requalification documentation

• Assist with future validations or revalidations of systems, equipment, or processes

• Verify Preventive Maintenance activities are completed in accordance with contractual agreements

• Collaborate with functional and departmental managers to support new programs and change management of existing processes

• Maintain and enhance the training reference material and training program by ensuring training assignments are current and completed for new hires and existing employees

• Perform additional responsibilities as assigned to support the Quality and Compliance program

Requirements

• Bachelor’s Degree in technical discipline (science or engineering) or related field; or equivalent combination of education and experience
• Minimum of 3 years of experience in quality management at an ISO certified or FDA regulated drug, biologic, or medical device manufacturer or distribution center
• Experience with Master Control Quality Management software or Master Control is strongly preferred
• Proficient in Microsoft Office, including strong Word, Excel, and Outlook
• Must have excellent communication skills, both written and verbal
• Ability to communicate with individuals at all levels of an organization
• Must have strong math and computer skills
• Must have knowledge using an ISO quality system or cGMP quality system in a storage or distribution facility
• Ability to multi task and be forward thinking
• Successfully pass a pre-employment (post offer) background check and drug screening

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Hard Skills

• Quality Management
• Root Cause Analysis
• Corrective and Preventive Actions (CAPA)
• Document Control
• Change Control
• Internal Audits
• Vendor Qualification
• Preventive Maintenance
• Training Program Development
• Quality Documentation

Soft Skills

• Excellent Communication Skills
• Ability to Multi-task
• Forward Thinking
• Interpersonal Skills