Specialist II, Quality Systems

Description:

QUALIFICATIONS

Required:

• Bachelor’s Degree or equivalent combination of education, training, and experience.
• 2 years of experience in Quality Assurance for the pharmaceutical or medical device industries.

Preferred:

• Experience in record review and material disposition
• Experience working within SAP (Business Client and ERP, specifically QM module)

Skills & Competencies:

• Effective communication skills – verbal and written
• Solid understanding of Quality System requirements (i.e. CAPA, nonconformances, etc.) in a regulated medical device or pharmaceutical environment
• Strong understanding of device and/or pharmaceutical regulatory and compliance requirements
• Excellent analytical abilities, effective communication skills, and effective attention to detail
• Strong leadership and interpersonal skills.
• Ability to mentor and coach peers and colleagues.
• Capable of developing key performance metrics and implementing actions that make improvements in those metrics.
• Ability to work independently and in a group on a variety of projects.
• Ability to maintain a high degree of accuracy and attention to detail.
• Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
• Ability to monitor and report on assigned tasks, goals, and objectives.
• Competency with electronic document managements systems
• Proficiency in Microsoft Office (Word, Excel, Outlook, etc.).

Experience in developing and conducting presentations with PowerPoint

Physical Requirements:

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.

RESPONSIBILITIES:

• Responsible for providing Quality oversight for established Quality Systems which include Document Control and Records Retention, Training Compliance, and Internal Audit Program
• Assure consistent quality of production by developing, overseeing, and enforcing current Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Define and communicate Quality requirements for the Mfg. Facilities
• Conduct and oversee Document Control and Training Compliance processes of the Quality System.
• Directly supports the Senior Director, Quality and Senior Manager, Quality Systems with Notified Body ISO13485 Audits, Customer Audits, and Regulatory Body Inspections (including FDA),
• Manage the implementation, maintenance, compliance and continuous improvement of Quality Systems (FDA 21CFR Part 820, ISO 13485:2016, CMDCAS, and EU MDR 2017/745) based on established direction and priorities
• Contribute to strategic Quality planning and review of the status of the Quality System.
• Assist with the implementation, maintenance, compliance and improvement of the company Training program
• Report routine Quality metrics to the Senior Management team
• Maintain Document Control release, Document Control Storage Room, and electronic Quality System records
• Maintain the Training Compliance program and identify continuous improvement opportunities
• Assist with the assembly and execution of Management Review
• Help develop and deploy quality system training, including GMP, GDP, and FDA Readiness training programs
• Execute other duties and projects, as assigned by the Senior Director, Quality and/or Senior Manager, Quality Systems