Pharmaceutical Senior QA Specialist

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.