Company: Morgan Prestwich Pharmaceutical Recruitment
Location: United States
Closing Date: 15 Mar 17
Type: Full Time
Salary (£): 60,000 - 80,000
Benefits: Competitive Salary, Bonus Scheme, 401K, Healthcare
Auditor. GCP (Good Clinical Practice) + GxPs (GLP / GMP) United States. West Coast & Potentially - Nationwide Home Based Position – Travel to audits Strong GCP (Good Clinical Practice) + GxPs Auditor required 4+ Years GCP Lead/Solo Auditing experience require - Clinical Investigator Sites and Vendors
Auditor. GCP (Good Clinical Practice) + GxPs (GLP / GMP)
Seeking an experienced clinical research GCP (Good Clinical Practice) auditor with additional GxPs auditing experience, Preferably - GLP (Good Laboratory Practice) and/or – GMP (Good manufacturing 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.
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) Investigator Site Auditor to work fully remote home based in the United States.
You will undertake a range of rewarding and challenging solo GCP audits for multiple Clients and Vendors, including Investigator Sites / CRO's and Laboratories involved in Clinical Research. Additionally, you may also undertake additional GxP audits – Preference for additional GLP or GMP auditing experience. You should have experience in at least one other GxP in addition to your main auditing experience for GCP.
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 QA of at least 5+ years to date and will be able to demonstrate the abilities required to work independently and to manage your travel and audit follow up responsibilities from a home 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 4+ years continuous work within industry direct (And/Or) additional consulting work to industry with at least 3+ years in industry direct. You will be able to clearly demonstrate your experience working as a solo/lead GCP (Good Clinical Practice) Investigator and vendor site auditor – for at least 3+ years.
> Additional GxPs auditing experience - (GLP, GMP) 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.
* You will be available and eligible to travel locally, nationally and international if required, and be comfortable with travel circa 40-50% 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 / West Central.
* Home Based. With eligibility to travel as required without Visa / travel restrictions
* Registrations, accreditations or certifications - Preferred (RQAP-GCP/GLP)
Our client offers a competitive base salary, generous start holiday allowance, 401K, Healthcare/Dental, and provides its consultants 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:
S.Felton: +44 (0)208 144 6778
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