GCP Audit-On Site NJ- (232698)

Engineering Services | Healthcare IT | Life Sciences & Technology

Audit Particulars Description/Requirements

Audit Type Re-qualification (GCP)

• Clinical Trial Management

• Biostatistics

• Data Management

• Medical Monitoring

Delivery On Site audit

Audit time breakdown:

Audit Preparation and document review 10 hours (Audit Preparation)

2 hours – Training on Roivant SOP

Audit Conduct 24 (3 day, 8 hrs./day)

Audit reporting 20 hrs.

Total audit hours 56 hours

We are seeking consultants who can provide support as a Quality Compliance Auditor (GCP and GCLP) in a pharmaceutical and biotechnology industry.


• Conduct and manage quality, compliance, and auditing activities to provide assurances that operational activities are conducted in compliance with applicable regulations, guidelines and the company’s policies and standards.

• Support contracted audits to verify compliance.

• SME to assist with facilitation of audits in preparations for and participate in regulatory authority inspections.

• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses.

• Provide consultation and compliance advice for the organization and support a quality framework that protects patient safety and assures regulatory compliance.

• Interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.

• Support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives.

• Delivery of training in performance of audits (basic, intermediate, complex).


• A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.

• Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable.

• 10 years industry experience on a regulated environment

• With lead auditor certification is preferred

• Experience of industry quality systems/standards.

• Extensive knowledge of GCP and GLP requirements is a MUST

• Experience on CAP and CLIA is a MUST

• Expanded Laboratory Management Solutions (ELMS) knowledge is preferred

• Experience on PBMC (Peripheral blood mononuclear cell) is preferred

• Knowledge on toxicology is preferred

• Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving.

• Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios.

GCP Audit-On Site NJ- (232698)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
New Jersey

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