Clinical Auditing Specialist II

Notes:
- while is a remote role it does require 25% +/- travel to sites

Summary

Conducts complex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, sup ports determination of root cause of non - conformance and assists in developing strategies to address issues. May perform technical document review and other GxP activities in support of project work or company process. Provides finished audit reports to ma nagement. Plans and delivers billable quality services for clients and projects

Essential Functions and Other Job Information :

Essential Functions

• Conducts and/or leads a variety of client, internal or GxP audits and regulatory inspections as requested by senior management

• Performs directed site audits, facility, vendor a nd/or sub - contractor audits

• Provides GxP consultation and support to project teams and external clients

•Leads process audits and may participate as a co - auditor in more complex system audits

Performs other types of QA audits or activities (e.g. database a udits, clinical study report audits, sample results tables, process improvement)

• Serves as a knowledgeable resource to operational departments on audit or quality assurance subject matter

• Prepares and presents audit findings and/or other related informatio n at departmental, internal operations or client meetings •

• Job Complexity:

• Works on problems of moderate scope where analysi s of situations or data requires a review of a variety of factors.

Job Knowledge:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

SupervisionReceived:

• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Exercises judgment within defined procedures and practices to determine appropr iate action.

Business Relationships:

• Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters.
• Builds productive internal / external working relationships.

Qualifications:
Education and Experience :

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• GCP/Auditing Experience
• ​ In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities

• GCP experience
• Experience working in GCP Environment
• Auditing experience

Please note there is ~25% travel required

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!