Senior Clinical QA Auditor - Discovery Solutions LLC Recruiting

Position Description

Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.

Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.

Currently looking for a Senior Clinical QA Auditor

General Summary:
Plans and conducts GCP audits of clinical trials, vendors and internal documents and processes. Issues audit reports, recommends corrective action. Acts as Clinical QA project liaison. Keeps Company management informed of compliance status. Prepares company and clinical sites for regulatory inspections. Participates on inspection team. Reviews and recommends compliance related policies/procedures; provides training when necessary. Evaluates impending regulations, guidelines and industry standards and their impact on the clinical trials and the company. Note this position requires approximately 35% travel.

Essential Duties and Responsibilities:
Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

Plans and conducts GCP audits, as either lead or co-auditor. Audits may include clinical sites, vendors and internal document and process audits.
Issues audit reports, recommends corrective action and may conduct follow-up to audits and corrective actions.
Provides timely written reports to inform management of Company’s regulatory compliance status.
Acts as Clinical QA project liaison.
Prepares company and clinical sites for regulatory inspections; participates on inspection team.
Participates in clinical trial product complaint management system.
Performs GCP training. May train and mentor junior level auditors.
Assists with development of Clinical QA SOPs, compliance tracking tools and audit worksheets.

Essential Skills, Knowledge and Experience:
BA/BS in Health Sciences or related field.
At least 3 years of Clinical QA experience, which includes internal and external GCP audits, is required. Previous monitoring experience is preferred but not required.
Demonstrates a thorough knowledge of GCP regulations and guidelines.
Excellent written and oral communication skills and interpersonal skills.
Ability to effectively manage multiple projects.

How to Apply

Contact Information:

Debbie Wilmer

443-402-1585

Debbie.wilmer@discoverysolutionsllc.com

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