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Digital Prospectors Quality Assurance Auditor in Lexington, Massachusetts

Quality Assurance Auditor

Lexington, MA

Job Type: Direct Hire

Recruiter: Stacia McMillan (https://digitalprospectors.com/our-team/stacia-mcmillan)

Phone: 603.225.0616

Find your job at www.LoveYourJob.com

Job Title: QA Auditor

Location : Burlington, MA

Duration: Direct Hire

POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

JOB DESCRIPTION:

Assisting with the conduct internal and external GCP/GLP audits, assisting with vendor oversight activities, writing audit reports, participating in the audit response and corrective action process, verifying implementation of corrective actions, assisting with writing and revising documents and procedures. Participating in customer audits, third party audits and national or international regulatory agency audits.

RESPONSIBILITIES:

  • Conducting internal and/or external audits and inspections to ensure they comply with established quality assurance processes, standards, regulatory guidelines and/or client contractual obligations.

  • Performing laboratory walkthroughs of designated laboratory areas and applicable 3rd party vendors.

  • Planning, executing, and following up on audits, including preparation of audit reports and documenting findings.

  • Working with various departments, resolving compliance issues, providing recommendations for corrective actions; maintaining continuous communication throughout problem resolution process.

  • Providing training as needed regarding compliance issues, regulation changes and criteria across the site.

  • Supporting and maintaining audit files and ensuring proper documentation standards are adhered to.

  • Assisting with preparation for and hosting of client audits and/or regulatory inspections.

  • Coordinating the responses and corrective actions associated with the audits.

  • Assisting with approved supplier quality management activities

Qualifications:

  • BS or BA in science related field or equivalent combination of training and experience with five or more years of related Quality Assurance experience.

  • Working knowledge of GCP, GLP, Part 11 regulations, FDA Guidances for Industry, EU regulations, and other standards.

  • GLP experience is preferred but not required.

  • Requires an understanding of internal auditing standards as well as risk assessment practices.

  • Able to anticipate problems, identifying and investigating them, and making recommendations to help resolve.

  • Able to exercise good judgment and effectively balance work activities and changing priorities.

  • Strong organizing skills, ability to problem solve, demonstrating critical thinking and decision making skills.

  • Able to travel as needed, both domestically and internationally.

Make this your next career move as one of our many long-term contractors or employees!

Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

ABOUT DIGITAL PROSPECTORS:

Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.

Come see why Digital Prospectors has been voted “ Best Staffing Firm to Temp For ” by Staffing Industry Analysts, " Best of Staffing " for candidate satisfaction by Inavero / CareerBuilder.com, " Top Temporary Placement Firm " by Boston Business Journal, " Best Company To Work For " by Business NH magazine, " Excellence in IT and Engineering Staffing ” by TechServe Alliance, " Top IT Services Company " by Inc. Magazine, " Most Reliable Staffing Agency " in Forbes Magazine and " Top Ranked Staffing Firm " by Staffing Industry Analysts.

www.LoveYourJob.com

Phone: 603-772-2700

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