Senior Quality Assurance Engineer

Summary Of Major Responsibilities

The Senior Quality Assurance Engineer will provide support to Operations for a variety of functions; including process validation, facility validation, test method validation, and process risk management. The position will work within defined protocols and procedures and may lead or assist in developing and documenting new procedures for Operations relating to validation.

Essential Duties And Responsibilities

• Lead Quality representatives on design transfer and process improvement projects.
• Assist the validation project lead and operations manager in project management and status updates for ongoing activities.
• Partner with and provide support to Operations personnel in the completion of material receipt documents and records.
• Implement processes to monitor product and process performance, compliance, and reliability.
• Implement, conduct, and report on process quality programs using statistical data analysis.
• Provide support to operations in identification of risk associated with data and process trending.
• Participate and provide Quality perspective for scale up activities including validation requirements.
• Partner with and provide support to Operations personnel in the completion of production documents and records as well as material release.
• Lead process risk assessments.
• Lead and assist Operations in the generation, execution, and review of process, test method, and facility qualification/validation and process improvement projects.
• Review and approve documents prepared by other team members and Operations personnel.
• Provide Operations support for Investigations, Out-of-Specifications, Nonconformances, Deviations, and material release.
• Initiate/own CAPAs, manage a CAPA team, lead a CAPA investigation, and report on status at the Quality Review Board.
• Perform supplier audits.
• Generate and distribute monthly and quarterly Quality metrics as assigned.
• Generate, prepare, and issue data for assigned quality plans.
• Provide mentorship and training to new and existing team members.
• Ability to frequently and accurately communicate with employees and suppliers in person, via the telephone, or by email.
• Ability to lead and work effectively with and through multi-functional teams to achieve results.
• Ability to collaborate and work effectively with suppliers in change and exception management.
• Excellent interpersonal skills with the ability to collaborate closely with Operations staff at varying levels to drive compliance and operational excellence.
• Excellent oral and written communication skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company's Quality Management System policies and procedures.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to lift up to 40 pounds for approximately 25% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to provide on-site support as needed.
• Ability and means to travel between Madison locations.
• Ability to travel 15% of working time away from work location, may include overnight/weekend travel.

Qualifications

Minimum Qualifications

• Bachelor's degree in a Science or technical field; or Associates degree in Science or technical field and 2 years of relevant experience as outlined in the essential duties in lieu of a Bachelor's degree.
• 8+ years of experience in a manufacturing operation environment.
• 5+ years of experience in quality principles and practice.
• 3+ years of experience in process validation principles and practice.
• Demonstrated ability to successfully work within an CFR 820, ISO 13485, ISO 9001, and/or cGMP structured environment.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• 5+ years of experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment.
• Experience with Project Management principles and practice.
• Demonstrated experience in support of supplier qualification and monitoring programs.
• Demonstrated experience in leading Validation Projects in a GMP environment.
• Demonstrated experience in leading Facility expansion and qualification.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.