GCP/GLP Quality Assurance Auditor
HAYS

Cambridge, Massachusetts

Posted in Recruitment Consultancy


This job has expired.

Job Info


The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Biotechnology Company is seeking a GCP/GLP Quality Assurance Auditor in Cambridge, MA.

Role Description

This position will include the following major areas of responsibility. Assist with the conduct internal and external GCP/GLP audits, assist with vendor oversight activities, write audit reports, participate in the audit response and corrective action process, verify implementation of corrective actions, assist with writing and revising documents and procedures. Participate in customer audits, third party audits and national or international regulatory agency audits.

• Conduct internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines and/or client contractual obligations.
• Perform laboratory walkthroughs of designated laboratory areas and applicable 3rd party vendors.
• Plan, execute, and follow up on audits, including preparing audit reports and documenting findings.
• Work with various departments in order to resolve compliance issues, provide recommendations for corrective actions; maintain continuous communication throughout problem resolution process.
• Provide training as needed regarding compliance issues, regulation changes and criteria across the site.
• Support and maintain audit files and ensure proper documentation standards are adhered to.
• Assists with preparation for and hosting of client audits and/or regulatory inspections.
• Coordinates the responses and corrective actions associated with the audits.
• Assist with approved supplier quality management activities

Skills & Requirements

• BS/BA in science related field or equivalent combination of training and experience with 5 + years of related Quality Assurance experience.
• Working knowledge of GCP, GLP, Part 11 regulations, FDA Guidance's for Industry, EU regulations, and other standards.
• GLP experience is helpful, but not required.
• Must have understanding of internal auditing standards and risk assessment practices.
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.
• Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
• Strong organization, problem-solving, critical thinking and decision-making skills.
• Willing to travel as needed, domestically and internationally.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.
#1117261


This job has expired.

More Recruitment Consultancy jobs


Kforce Inc.
Wakefield, Massachusetts
Posted 16 minutes ago

Kforce Inc.
Billerica, Massachusetts
Posted 16 minutes ago

Kforce Inc.
Boston, Massachusetts
Posted 16 minutes ago

Get Hired Faster

Subscribe to job alerts and upload your resume!

*By registering with our site, you agree to our
Terms and Privacy Policy.