Quality Assurance Specialist

Description

The company makes medical technology, including imaging, laboratory diagnostics, molecular medicine and digital health services, with over 170 years of experience and more than 48,000 employees in over 70 countries.

This is a Corporate Quality Specialist role for an ambitious professional ready for their next career step. It is on-site in Knoxville, TN and is not remote.

The team supports US sites that make and distribute radioactive sterile PET injectables under 21 CFR Part 212, USP 825 and Radiopharma quality standards.

Responsibilities

• Provide quality oversight for the Production Support Lab, the Technical Support Team and the Implementation Team.
• Act as Quality System Officer (QSO) for the listed corporate teams.
• Help the Corporate Quality group with root cause and trend analysis of analytical equipment and manufacturing technical issues, supporting GMP investigations and CAPAs.
• Review assigned GMP investigations, CAPAs, change controls and similar records to confirm the technical content is accurate.
• Act as subject matter expert on assigned topics, advising on policies, procedures and decisions.
• Take part in continuous improvement and trend analysis projects as assigned.
• Review qualifications and other documents, deliver GMP training to corporate staff when needed, and support audits and inspections for Radiopharma quality oversight.

Requirements

• Experience in pharmaceutical manufacturing, preferably sterile drug manufacturing, and/or PET radiopharmaceuticals under 21 CFR Part 212, Part 11 and/or USP 825.
• At least 3 years manufacturing radiopharmaceuticals and at least 3 years running QC testing on radiopharmaceuticals.
• Working knowledge of problem-solving, root cause analysis, investigation writing and corrective and preventive action management.
• Ability to spot procedural gaps and product risk, and recommend contingency plans and strategies to manage compliance.
• Ability to coordinate across departments to keep tasks on track and compliance intact.
• Studies in microbiology, analytical chemistry or a similar technical field.
• Strong self-management of your schedule so all assigned work is finished accurately and on time.
• Solid PC skills in Word, PowerPoint, Excel and Outlook.
• Willingness to travel and adapt to changing needs.
• Bachelor's degree in a scientific field such as biology, chemistry, microbiology or pharmacy is preferred; equivalent experience is required.
• Exceptional attention to detail, with efficient schedule management so all duties are done on time and to a high standard.
• Creative problem solving, with the ability to reprioritize several times a day while keeping pace with the business and delivering on time.
• Travel of about 10%.

Conditions

Based in Knoxville, TN; this is not a remote role.

Base pay range is $91,850 to $126,291, with starting pay depending on geography or market, skills, education, experience and other qualifications.

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

Must be able to work with controlled technology under US export control law.

Equal-opportunity employer open to applicants with disabilities; reasonable accommodations are available.

Benefits

• Medical, dental and vision insurance.
• 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.
• Benefits are subject to eligibility requirements.