Pharmaceutical Senior QA Specialist - Capa

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 skilled and detailed-oriented 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 managing the Corrective and Preventative Action (CAPA) module, process and monitoring key quality metrics.

You will play a key role in ensuring the timely and effective resolution of CAPAs while maintaining accurate and comprehensive metrics to drive continuous improvement efforts. You will be the primary, responsible for driving CAPA review board and resolution of internal, corporate, third-party, and regulatory audit commitments through closeout. You will serve as Quality approver for CAPA effectivity checks, escalating and issuing additional investigations/ CAPAs if required. You will serve as Subject-Matter-Expert and lead CAPA owner, Effectiveness Check development, reviewer, and QA approver training certification programs.

POSITION RESPONSIBILITIES:

• Oversee and coordinate the CAPA process, ensuring timely initiation, investigation, implementation, and closure of CAPAs across the organization.

• Facilitate root cause analysis activities, ensuring comprehensive evaluation of underlying issues and the development of appropriate corrective and preventative action.

• Establish key quality metrics to collect and analyze data on CAPA trends, root causes, and effectiveness checks to identify areas of concern or improvement ideas.

• Develop and revise standard operating procedures, work instructions, and other relevant documentation related to CAPA process.

• Provide guidance and support to personnel involved in CAPA investigations, promoting consistent and effective practices.

• Create training materials to certify CAPA and effectiveness check owners, reviewers, and approvers.

• Provide input and assist in the preparation and support of regulatory inspections and audits related to CAPA and continuous improvement.

Qualifications

• Bachelor's or Master's Degree in scientific field

• Bachelor's and 4-6 years of relevant experience

• Master's and 2-4 years of relevant experience

• Relevant experience includes:

• Leading CAPAs or change controls

• Strong technical writing ability

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

• Microsoft OfficeTM applications (Word, Excel, PowerPoint)

• Proficient using statistical analysis tools including control charts, distribution modeling, etc.

• Green or black belt certification is a plus

• Valid drivers license and personal transportation

Additional Information

Position is Full Time, Monday-Friday, 8:00am-5:00pm. 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.