Quality Assurance Specialist

Description

The company makes radiopharmaceutical products and works across healthcare, aiming to improve patient outcomes with medical technology. The team includes more than 72,000 people in over 70 countries.

This role suits an ambitious professional ready for their next career step, in a setting that encourages you to go beyond your comfort zone with resources and flexibility for growth.

The quality role covers a US site that makes and ships sterile injectable PET radiopharmaceuticals under 21 CFR Part 212 and USP 825 for the radiopharma business.

Responsibilities

• Oversee quality at the US site, covering GMP investigations, CAPAs, change management, batch release, batch record review, quality audits and data integrity audits.
• Train and mentor staff on site, run 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 failed by 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 production, and/or PET radiopharmaceuticals under 21 CFR Part 212, Part 11 and/or USP 825.
• Ability to 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.
• Ability to spot procedural gaps and product risk, and to recommend contingency plans that reduce compliance exposure.
• Studies in microbiology and/or analytical chemistry.
• Working knowledge of MS Office (Word, PowerPoint, Excel and Outlook).
• Strong attention to detail.
• Creative problem solver who can reprioritize several times a day and still deliver on time.
• 3 to 5 years of quality assurance experience in a 21 CFR Part 211 or 212 regulated industry.
• A bachelor's degree in a scientific field such as biology, chemistry, microbiology or pharmacy is preferred, or equivalent experience is required.
• Able to travel, typically 10% to 25% of the time.

Conditions

Base pay range is $101,030 to $138,919, with starting pay depending on location 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.

Equal opportunity: applicants are protected under federal law against discrimination, and reasonable accommodations are available for people with disabilities.

Benefits

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