Quality Assurance Specialist - Minneapolis, MN

Description

The company is a global medical technology group with more than 72,000 employees in over 70 countries, working to improve patient outcomes through its diagnostic and treatment products.

The team is made up of scientists, clinicians, developers, researchers and specialists from many backgrounds, and it encourages people to bring different ideas and to grow both professionally and personally.

This role suits an ambitious quality professional who is ready for the next step in their career and wants to build a long-term path with the company.

Responsibilities

• Provide quality oversight for a US site that makes and distributes radioactive sterile injectables for PET imaging, in line with 21 CFR Part 212 and USP 825.
• Handle GMP investigations and CAPAs, change management, batch record reviews and batch release, and run site quality audits and data integrity audits.
• Support training and mentoring on site, carry out internal and third-party quality audits, and host and support FDA inspections.
• Act as the subject matter expert on assigned topics and give input on related policies, procedures and decisions.
• Take part in continuous improvement projects.
• Track site quality metrics, with a focus on cutting batch record corrections, investigations and batches that fail because of operator error, plus any other metrics assigned to you.
• Review internal forms, manage inventory, observe staff qualifications and inspect the facility.
• Identify procedural gaps and product risks, and where appropriate recommend contingency plans and strategies to reduce compliance risk.
• Reprioritize several times a day while keeping pace with the business and delivering results on time.

Requirements

• Experience in pharmaceutical manufacturing, ideally sterile drug manufacturing, and/or PET radiopharmaceuticals under 21 CFR Part 212, Part 11 and/or USP 825.
• Experience interpreting regulatory policies and guidance and applying them correctly to daily work.
• Deep expertise in quality assurance, including root cause analysis, investigation writing, and managing corrective and preventive actions.
• Coursework in microbiology and/or analytical chemistry.
• Proficiency with Microsoft Word, PowerPoint, Excel and Outlook.
• Willingness to travel.
• A scientific bachelor's degree (such as biology, chemistry, microbiology or pharmacy) is preferred, or equivalent experience is required.
• Excellent attention to detail.
• Creative problem-solving skills.
• 3 to 5 years of QA experience in an industry regulated under 21 CFR Part 211 or 212.
• Willingness to travel 10% to 25% of the time.

Conditions

Based in Minneapolis, MN, at a US site.

Base pay ranges from $91,850 to $126,291, and starting pay within that range depends on factors such as location, skills, education, experience and other qualifications.

If the role is commission eligible, commissions follow the company plan and depend on individual and/or company performance.

Successful candidates must be able to work with controlled technology under US export control law, and the company is an equal opportunity employer that provides reasonable accommodations.

Benefits

• Medical, dental and vision insurance, subject to eligibility.
• 401(k) retirement plan.
• Life insurance, plus long-term and short-term disability insurance.
• Paid parking or public transportation.
• Paid time off and paid sick and safe time.