QA Senior Specialist - Change Controls

Company Description

The work we do at Eurofins matters, and so do our employees. At Eurofins, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

If you're looking for a rewarding career, a place to call home, apply with us today!

Job Description

POSITION SUMMARY:

We are seeking a detail-oriented and highly organized Sr. QA Specialist to join our team. As the Sr. QA Specialist within the Digital Systems and Compliance organization, you will be responsible for coordinating and overseeing the change management process. You will play a key role in ensuring the timely and effective initiation, review, approval and closure of change controls while maintaining accurate and comprehensive metrics to drive continuous improvement efforts. You will serve as Subject-Matter-Expert, lead reviewer and QA approver for the change management training certification program.

POSITION RESPONSIBILITIES:

• Lead the change management process, ensuring adherence to established procedures and timelines.

• Serve as the primary point of contact for change control owners and cross-functional teams, providing guidance and operational support throughout the change management process.

• Develop and maintain quality metrics related to change controls, ensuring accurate and up-to-date records and translate to written reports and presentations.

• Create training materials to certify change control initiators, owners, reviewers, and approvers.

• Assist in the preparation and support of regulatory inspections and audits related to change controls.

• Analyze and interpret change control metrics, identifying trends, patterns, and opportunities for improvement.

Qualifications

BASIC MINIMUM QUALIFICATIONS:

• Bachelor's degree and 6-8 years or relevant experience, OR;

• Master's degree and 4-6 years of relevant experience

• Change Control experience

• Strong technical writing and presentation skills

• Experience in pharmaceutical, medical device, or combination product industry

• Proficient in Microsoft OfficeTM applications (Word, Excel, PowerPoint)

• Valid drivers license and personal transportation

PREFERRED QUALIFICATIONS:

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

• Green or black belt certification

• Experience using TrackWise, Veeva, or similar Quality Management System software

Additional Information

Position is Full Time, Monday-Friday, 8:00am-5:00pm with overtime and weekend work as needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

• Eligibility for potential yearly Bonus & Merit-Based Pay Increases

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.