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Job Details

GCP Auditor (Good Clinical Practice). United States. Home Based

Company: Morgan Prestwich Pharmaceutical Recruitment
Location: United States
Reference: 0007541kgdd301
Closing Date: 19 Aug 17
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Salary, Bonus Scheme, Pension, Healthcare

Job Summary:

Auditor. GCP (Good Clinical Practice) + GxPs (GLP / GMP) United States. Home Based Location: West Coast/Mid-West central Home Based Position – Travel to audits, predominantly within the US Strong GCP Auditor (Good Clinical Practice) + GxPs Auditor required 5+ Years GCP Audit Experience - Clinical Trials (Clinical Investigator Sites / CRO's / Labs etc.) 3+ Years Lead/Solo Auditing experience

Requirements:

Auditor. GCP (Good Clinical Practice) + GxPs 

United States. Home Based

  • Location: West Coast/Mid-West central
  • Home Based Position – Travel to audits, predominantly within the US
  • Strong GCP Auditor (Good Clinical Practice) + GxPs Auditor required
  • 5+ Years GCP Audit Experience - Clinical Trials (Clinical Investigator Sites / CRO's / Labs etc.)
  • 3+ Years Lead/Solo Auditing experience

Seeking an experienced clinical research GCP (Good Clinical Practice) auditor with additional GxPs auditing experience, Preferably - GLP (Good Laboratory Practice)

You will be an established solo clinical investigator site auditor with a high level experience and knowledge of regulatory requirements and industry guidelines governing global GCP - FDA required.

Ideally, you will be located on the West Coast / West Central side of the United States, with good local access to a main connecting airport. Other locations in the US will also be considered.

Overview:

My client is a leading full service GxP QA Specialist organisation, with true global reach, and a growing team of successful QA auditing professionals working across GxP auditing specialisms with multiple industry leading clients, vendors / CRO’s.

As part of their continued US audit team growth, they seek an experienced GCP (Good Clinical Practice) Clinical Investigator Site Auditor to work fully remote - home based in the United States.

You will undertake a range of rewarding and challenging solo GCP or GLP audits for multiple Clients and Vendors, including Investigator Sites / CRO's / Biotech and Laboratories involved in Clinical Research. 

Requirements:

You will already be an experienced solo/lead GCP (Good Clinical Practice) Auditor, with proven solo auditing experience in the United States (And/Or) internationally for multiple GCP Investigator sites/ CRO’s and Vendors for at least 4 years continuous within industry And/Or consulting.

You will have a proven background within Quality Assurance 5+ years to date and will be able to demonstrate the abilities required to work independently and travel plus all audit follow up responsibilities and reports from a home based office set up.

You will demonstrate the skills required to work effectively and smart to meet deadlines and clients time criteria’s, and to always demonstrate a professional outlook to uphold the high standards and reputation of the client.

Auditing experience ideally to include 3+ years continuous work within industry direct (And/Or) additional consulting work of 1+ year. You will be able to clearly demonstrate your experience working as a solo/lead GCP (Good Clinical Practice) Investigator and vendor site auditor.

Additional GxPs auditing experience - GLP Or (GvP, GcLP)

Additional Skills / Knowledge Required:

You will be fully experienced in writing full and detailed audit reports, and will be expected to complete these for each vendor/client site audit undertaken.

You will clearly demonstrate a strong work ethic to managing daily tasks and working to tight timelines, ensuring each individual client/vendor audit project is completed to the same exemplary high levels and standards every time.

Travel Requirements:

* You will be available and eligible to travel locally, nationally and international if required, and be comfortable with travel circa 40% of the working time.

* If you are a dynamic, motivated and driven Quality Assurance GCP Auditing professional, seeking more scope to work independently, home based, with a real consulting feel and a guaranteed employed income together with full benefits – This may be the ideal auditing opportunity for you.

Our client has a broad portfolio of clients across the United States, South America, Canada, Europe, APAC and Global. You will be working across a continual broad range of GCP auditing projects.

* Travel - Across the US/North America. Potential Worldwide ad-hoc as required

* Solid knowledge of international regulatory requirements desired + Industry guidelines governing GCP (Good Clinical Practice), GMP, GLP - ICH, EMA and FDA - 21 CFR part 11. EU also advantageous

* Ability to assimilate and analyse information rapidly

* Life Science Degree minimum. BSc / MSc. PharmD, PhD

* Current resident in the United States - Nationwide. Preference to West Coast / Mid-West / Central.

* Home Based. With eligibility to travel as required without Visa / travel restrictions

* Registrations, accreditations or certifications - Preferred (RQAP-GCP/GLP)

Package:

Base salary - US$85,000 to US$108,000.00 Depending on experience

Our client offers a competitive package including; Generous holiday allowance, 401K, Excellent Healthcare/Dental care plan. A broad renage of auditing projects allows employees the scope to develop their career, together with an exciting portfolio of clients across Pharma, Biotech and CRO's.

Apply today and forward your CV for consideration

Email: simon.felton@morganprestwich.com

Apply for this job: GCP Auditor (Good Clinical Practice). United States. Home Based

Contact Information:

Address:  Head Office


England
Tel:  +44 (0) 1737 22 66 44
Fax:  +44 (0) 1737 22 27 87
Website:  Visit Our Web Site

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