Sr. Quality Analyst

Talascend is seeking qualified candidates to apply for a Sr. Quality Analyst contract position located in Madison, WI. 

OVERVIEW: 

The Senior Quality Analyst is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the Madison facility This position will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and direct involvement and collaboration with the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

PRIMARY RESPONSIBILITIES:

• Develop and maintain quality system processes.
• Manage CAPA initiation, review, surveillance, and reporting.
• Facilitate the site Quality Management reviews.
• Facilitate and lead the site Change Management process.
• Coordinate facility audits by internal and external entities.
• Manage data collection and reporting when product recalls are required.
• Support and lead RCAs through cross functional team involvement.
• Perform trending of Quality Systems to support FDA and Management reviews.
• Coaching and mentoring others in regards to QMS and Quality Culture, including leading Good Documentation Practice training and Quality on the Floor coordination and performance.
• Improve existing procedures to align with cGMP and regulatory requirements.
• Interpret and properly apply all applicable regulatory requirements.
• Improve quality culture through site initiatives.
• Review and approval of procedures, protocols, reports, etc., as required.

Department specific/Non-essential responsibilities:

• Perform internal and external audits of systems and suppliers.
• Filing and management of documentation when required.
• Supporting other Quality System Functions.
• This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need.

POSITION REQUIREMENTS: 

• Bachelors, or higher, degree in science/technology program preferred.
• 5+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred).
• Effective communication, coaching/mentoring, and presenting skills.
• Ability to manage change.
• Self-motivated.
• Independent and sound decision making capabilities.
• Project management to deliver on time results.
• Leadership skills / Emotional Intelligence.
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.
• Proficient with Microsoft Office tools, especially Excel, Word and PowerPoint.
• Technical writing.
• Statistical analysis - Minitab or other software equivalent, preferred.