Quality Assurance Specialist - Cincinnati, OH

Description

The company runs the world's largest PET radiopharmaceutical network, shipping over 1 million doses a year with a fulfillment rate above 99% and supplying more than 2,800 imaging centers worldwide.

The team is more than 72,000 people across over 70 countries and works in medical technology to improve patient outcomes.

This suits an ambitious quality professional ready for the next step in their career.

Responsibilities

• Oversee quality at a US site that makes and ships sterile radioactive injectables for PET, following 21 CFR Part 212 and USP 825.
• Lead GMP investigations and CAPAs, manage change control, release batches, review batch records, and run site quality and data integrity audits.
• Train and mentor staff on site, carry out internal and third-party quality audits, and host or support FDA inspections.
• Act as the subject matter expert on assigned topics and advise 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 failed by operator error, plus any other metrics assigned to you.
• Also review internal forms, manage inventory, observe staff qualifications, and inspect the facility.

Requirements

• Work experience in pharmaceutical manufacturing, preferably sterile drug manufacturing, and/or PET radiopharmaceuticals under 21 CFR Part 212, Part 11 and/or USP 825.
• Interpret regulatory policies and guidance and apply them correctly to your work.
• Strong skills in problem solving, root cause analysis, investigation writing, and managing corrective and preventive actions.
• Spot procedural gaps and product risk, and recommend contingency plans and strategies to reduce compliance risk.
• Coursework in microbiology and/or analytical chemistry.
• Proficiency in Microsoft Word, PowerPoint, Excel and Outlook.
• Flexibility to travel, and willingness to travel 10% to 25% of the time.
• A bachelor's degree in a scientific field such as biology, chemistry, microbiology or pharmacy is preferred, or equivalent experience is required.
• Excellent attention to detail.
• Be a creative problem solver who can reset priorities several times a day, keep pace with the business, and deliver on time.
• 3-5 years of relevant QA experience in a industry regulated under 21 CFR Part 211 or 212.
• Ability to work with export-controlled technology under US export control law.

Conditions

The base pay range is $89,220 to $122,672, with starting pay depending on factors such as geography or market, 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.

Equal employment opportunity applies, and reasonable accommodations are available for people with disabilities.

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.