Senior Quality Assurance Engineer

Lifecore Biomedical, headquartered in Chaska, Minnesota, is a medical device company dedicated to the design and manufacture of innovative products that enhance the quality of life for people worldwide.

Senior Quality Assurance Engineer

In this position, you will ensure that new and existing processes, systems, and test methods are validated to comply with regulatory requirements, industry standards, and company policy. You will also ensure data is reviewed and trends are investigated in a manner to ensure product quality and review and approve validation protocols and reports.

Key Responsibilities:
Major:
• Review process data trends to proactively identify potential quality problems, investigate root cause and implement effective corrective action.
• Provide knowledge leadership and technical expertise for validations and investigations.
• To insure that validation plan and protocols are comprehensive, clearly written and technically sound.
• To use validation studies as tools to verify manufacturing controls and process limits.
• To manage process and equipment change to maintain product quality attributes.
• Provide technical expertise in support of supplier audits.

Secondary:
• To assist in the selection of process equipment or software.
• Participate in department journal review and related activities to remain abreast of the current state of pharmaceutical science.
• Support new business development projects as needed.

Requirements:
Education:
• BS in Life Sciences or Engineering preferred.

Experience:
• 5-8 years of Quality Assurance or Quality Engineering experience.
• Background in biology and/or chemistry production processes (Preferred).
• Certified Quality Engineer or Professional Engineer (Preferred).
• Cleanroom experience (Preferred).
• Knowledge of applicable industry standards and regulations.

Personal and Technical Skills:
• Excellent Organizational ability, capability to manage multiple, dynamic projects simultaneously.
• The ability to provide effective leadership in a group environment to insure accountabilities are completed in a timely and satisfactory manner.
• The ability to facilitate investigation, development and manufacturing activities to meet project goals.
• Strong understanding of pharmaceutical and fermentation processes and equipment.
• Experience performing process and facility audits to ensure internal and external suppliers meet the medical device and active pharmaceutical ingredient requirements.
• Knowledge, understanding and experience with FDA and ISO requirements applicable to aseptic manufacturing, cleanroom environments and validation.
• Willingness to work a flexible schedule.
• Excellent analytical and problem solving skills.
• Technical writing skills (reports, plans and protocols).
• Proficiency with standard business applications and specialized data collection and analysis software.

Lifecore offers an attractive salary and benefits package, as well as generous paid time off, flexible work week and matching 401(k). Please send resume to:

Lifecore Biomedical
3515 Lyman Boulevard
Chaska, MN 55318
Fax: (952) 368-3411
klweiss@lifecore.com
www.lifecore.com
Equal Opportunity Employer