QA Staff Associate - Computerized Systems and Electronic Records

The Staff Associate role is a specialist role within the QA function, requiring substantial regulatory QA expertise. The QA Staff Associate, Computerized Systems and Electronic Records is responsible for defining and overseeing inspection program(s) that are operated to assure compliance of our computerized systems, instrumentation, and electronic records. They will manage all aspects of such programmes, always ensuring that they are fully maintained in accordance with procedural requirements, and ensuring thorough follow up in terms of the close out of issues raised. In view of their extensive regulatory experience, these individuals will also play a significant role in guiding, advising, and influencing the organization on a range of compliance and data integrity matters.
• Defines, manages, and executes compliance auditing programmes
• Fully competent as a Lead Auditor
• Trains others in the conduct of external and internal audits.
• Conducts specialist audits as necessary (multiple GxPs; Data Integrity).
• Liaises with internal and external parties in order to arrange inspections
• Conducts preparation for inspections and briefs audit team as necessary.
• Ensures appropriate records are generated and maintained for all inspections.
• Formally communicates audit findings.
• Coordinates responses to inspection findings. Ensures findings and responses are recorded in the appropriate system to facilitate tracking.
• Follows up on actions to ensure timely completion and closure.
• Provides guidance on current regulatory thinking to all levels of the organization.
• Performs SOP reviews
• Ensure knowledge of current regulatory thinking is maintained
• Plays an active role in external industry regulatory forums (*)
• Active participant in Process Excellence initiatives.
• Conducts other activities, including GxP audits, as required.

Responsibilities/Duties

The Staff Associate role is a specialist role within the QA function, requiring substantial regulatory QA expertise. The QA Staff Associate, Computerized Systems and Electronic Records is responsible for defining and overseeing inspection program(s) that are operated to assure compliance of our computerized systems, instrumentation, and electronic records. They will manage all aspects of such programmes, always ensuring that they are fully maintained in accordance with procedural requirements, and ensuring thorough follow up in terms of the close out of issues raised. In view of their extensive regulatory experience, these individuals will also play a significant role in guiding, advising, and influencing the organization on a range of compliance and data integrity matters.
• Defines, manages, and executes compliance auditing programmes
• Fully competent as a Lead Auditor
• Trains others in the conduct of external and internal audits.
• Conducts specialist audits as necessary (multiple GxPs; Data Integrity).
• Liaises with internal and external parties in order to arrange inspections
• Conducts preparation for inspections and briefs audit team as necessary.
• Ensures appropriate records are generated and maintained for all inspections.
• Formally communicates audit findings.
• Coordinates responses to inspection findings. Ensures findings and responses are recorded in the appropriate system to facilitate tracking.
• Follows up on actions to ensure timely completion and closure.
• Provides guidance on current regulatory thinking to all levels of the organization.
• Performs SOP reviews
• Ensure knowledge of current regulatory thinking is maintained
• Plays an active role in external industry regulatory forums (*)
• Active participant in Process Excellence initiatives.
• Conducts other activities, including GxP audits, as required.

Education/Qualifications

• Bachelor of Science/Arts (BS/BA) degree (experience may be substituted for education in some circumstances).
• Intimate working knowledge of Covance SOPs, P&Ps as well as local and international GLPs, cGMPs, GCPs and regulatory agency guidelines as applicable.
• Ability to confidently interact with clients and regulatory personnel, and conduct effective training sessions.
• Ability to effectively negotiate ideas and suggestions.
• Proven organization, observation, and problem solving skills.
• Skilled in written and verbal communication.

Experience

All candidates would be considered on their own respective merits, but the following is the typical level of experience held by individuals in this position:
Several years in regulatory QA
Experience as a Lead Auditor
Demonstrable experience of successful client interaction
External podium presentations at relevant regulatory meetings (preferred)