Sr. Ops Quality Engineer

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Date: Jun 11, 2024

Location:

Raleigh, US

Job Type: Long-term/regular

Sr. Ops Quality Engineer M/F (29246)

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in contrast products for the last 95 years, we continuously innovate.

Customer centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram, and YouTube.

WHAT WE'RE LOOKING FOR:

We are seeking a dynamic and proactive individual to fill a senior-level position within our QA Compliance department. This role does not involve direct reports but requires cross-functional collaboration throughout the plant to maintain compliance levels. The ideal candidate will be a Subject Matter Expert (SME) for site compliance-related functions, including Exceptions, CAPAs, Distribution Non-Conformance (DNC), and Complaint investigations. This position is located at our Raleigh, NC site on day shift.

YOUR ROLE:

As a key member of our team, your responsibilities will include:

• Reviewing and approving site-related complaints, exceptions, and CAPA investigations in a compliant and timely manner.

• Possessing technical knowledge with the ability to write or review technical documents.

• Assisting in the completion of trending and metrics (i.e., Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis).

• Completing department requirements for site Annual Product Quality Reviews (APQRs).

• Performing investigations within each quality system when needed.

• Assisting in Quality inspections from regulatory agencies, internal audits, and customer audits.

• Providing final approval of site simplified and standard CAPA records.

• Providing data to Site Management upon request for EXC, CAPA, DNC, and Complaint records.

• Leading site Kaizens or brainstorming initiatives.

• Acting as Quality Assurance oversight for project teams.

YOUR BACKGROUND

Education

• A BS/BA degree in Life Sciences is preferred.

Experience

• A minimum of 10 years' experience in a pharmaceutical setting is preferred, with at least 5-6 years' experience in a Quality Assurance role.

Skills/Competencies

• ASQ certified inspector/auditor is preferred.

• Good documentation skills with an eye for detail.

• Ability to work in a fast-paced environment.

• Proficiency in multi-tasking.

• Well organized and dependable for consistent decision making.

• Strong Technical Writing Skills.

• Competency with MS Office software environment.

• Ability to interact with all levels of the organization.

This position offers a first shift office environment. Overtime or weekend work is dependent upon site demands. Visits to laboratory, manufacturing, warehouse, and other plant areas are required. We look forward to welcoming you to our team!

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position, please send an email to careers@guerbet.com or you can also call this number +19843443717

WHY GUERBET?

• 4 weeks of PTO

• Insurance benefits start date of hire

• Competitive 4% 401K match + 2% profit sharing contribution

• Tuition reimbursement program for ongoing education

• Paid time off for select volunteer opportunities