Specialist Quality Systems and Compliance IV

Job ID: 336736    Posted 3 weeks ago

Newark, California

Contract

Quality Assurance


85-90

Job Details

IDR is actively seeking a talented Senior Quality Assurance Specialist to join one of our top healthcare clients for a 6 month contract. This will be an hybrid position in Newark, CA. If you are interested in joining a great culture environment, please apply today!

 

Position Responsibilities:

  • Assist in computer systems assessment, implementation, enhancement projects, and rollouts.
  • Lead QA activities for systems implementation projects, quality records, and steady state operations.
  • Ensure system qualification and validation activities comply with regulatory standards and company policies.
  • Support Data Integrity program by leading gap and risk assessments, and remediation plans.
  • Develop SOPs and review validation strategies, plans, protocols, and procedures.
  • Attend project meetings and workshops, providing QA expertise.
  • Serve as QA SME under QSC Leadership supervision.
  • Assist in maintaining site-based computerized systems.
  • Assess, review, and approve change controls, deviations, and CAPAs.

 

Position Qualifications:

  • 5+ years of Quality Assurance/GXP systems experience
  • Expertise in 21 CFR Parts 11, 210, 211, 600, Eudralex Volume 4, and ICH guidance.
  • Proficiency in core quality processes and GXP computer systems validation.
  • Strong knowledge of validation methodology (GAMP) and SDLC principles.
  • Excellent communication, time management, and organizational skills.
  • Strong problem-solving abilities and coping skills.
  • BA/BS or equivalent education and experience.

 

What’s in it for you?

  • Competitive compensation package
  • Full Benefits; Medical, Vision, Dental, and more!
  • Opportunity to get in with an industry leading organization
  • Close-knit and team-oriented culture

 

Why IDR?

  • 25+ Years of Proven Industry Experience in 4 major markets
  • Employee Stock Ownership Program
  • Dedicated Engagement Manager who is committed to you and your success
  • Medical, Dental, Vision, and Life Insurance
  • ClearlyRated’s Best of Staffing® Client and Talent Award winner 11 years in a row

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Why Us?

IDR has been in business for over 25 years and offers access to hundreds of companies across the country to work for. For many of the contractors that work for us, there are some unique benefits to being a part of the IDR team. One specific benefit is that we believe our contractors are part of something bigger than yourself. We are an employee-owned company and in an ESOP (Employee Stock Ownership Plan), as the share price of our company grows, so does your equity in our company. Our contractors, as well as our internal employees, can participate in this plan after one year of service. In addition to joining our ESOP program, you will also receive weekly pay, 401k access, and access to three different benefit plans that cover 50% of the individual premiums along with access to unlimited behavioral health sessions with a licensed counselor.

About Us

IDR, Inc. is an award-winning, employee-owned staffing firm with headquarters in Alpharetta, GA and offices in the Nashville, Dallas, and Denver markets. Founded in 1998, IDR has grown to serve businesses and professionals across industries including IT, healthcare, accounting and finance, government services, and professional services. Recognized for our expertise and the high-touch approach of our Engagement Management Program, IDR continues to build rewarding partnerships with companies and consultants. Our best-in-class service has earned IDR ClearlyRated’s Best of Staffing Client and Talent awards for ten consecutive years, in addition to awards from Staffing Industry Analysts and Best and Brightest Companies to Work For. With our commitment to empowering talent and developing leaders, we’re passionate about what we do and how we do it, and we look forward to working with you.