Quality Assurance Specialist

Description

The company develops medical technology and works across healthcare, with a global team of more than 72,000 people in over 70 countries.

This is a Quality Specialist role for an ambitious professional ready for their next career step.

The role supports quality oversight of a US site that makes and ships radioactive sterile injectables for PET imaging, under 21 CFR Part 212 and USP 825.

The team is inclusive and encourages people to stretch beyond their comfort zone, with resources and flexibility for growth.

Responsibilities

• Provide quality oversight for a US site producing and distributing PET radiopharmaceutical sterile injectables under 21 CFR Part 212 and USP 825.
• Handle GMP investigations and CAPAs, change management, batch release, batch record reviews, site quality audits and data integrity audits.
• Train and mentor staff on site, run internal and third-party quality audits, and host or 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 fewer batch record corrections, investigations, and batches failed due to operator error, plus other assigned metrics.
• Review internal forms, manage inventory, observe staff qualifications and inspect the facility.

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 your work.
• Strong skills in problem-solving, root cause analysis, investigation writing, and managing corrective and preventive actions.
• Ability to spot procedural gaps and product risk, and recommend contingency plans and strategies to reduce compliance risk.
• Studies in microbiology and/or analytical chemistry.
• Experience with MS Office (Word, PowerPoint, Excel and Outlook).
• Relevant QA experience of 3-5 years in a 21 CFR Part 211 or 212 regulated industry.
• Excellent attention to detail.
• Creative problem solving and the ability to reprioritize several times a day while delivering on time.
• A bachelor's degree in a scientific field such as biology, chemistry, microbiology or pharmacy is preferred; equivalent experience is required.
• Flexibility to travel, 10% to 25% of the time.

Conditions

Base pay range is $101,030 to $138,919.

Starting pay within this range may depend on geography or market, skills, education, experience and other qualifications.

Commission eligibility, if applicable, follows the company plan and is based on individual and/or company performance.

The company is an equal opportunity employer and will provide reasonable accommodations for people with disabilities.

The role requires working with controlled technology under US export control law.

Applicants should not email CVs; instead, create a profile in the company's talent community. Be wary of recruitment scams and verify postings on the company career site.

Benefits

• Medical, dental and vision insurance.
• 401(k) retirement plan and life insurance.
• Long-term and short-term disability insurance.
• Paid parking or public transportation.
• Paid time off and paid sick and safe time.
• Subject to eligibility requirements.