Senior Specialist Quality Assurance â RDQA Compliance

2 months ago

Columbus, United States Abbott Laboratories Full time

Senior Specialist Quality Assurance â RDQA Compliance

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands â including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® â to help get the nutrients they need to live their healthiest life.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will also have access to:

  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, large free employee onsite gym with trainer led courses available Mon-Fri. Medical, Dental, & Vision Benefits start day 1.
  • Vacation â 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays.
  • 401(k) retirement savings with a generous company match of 5%
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting or paying off a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division.

The main purpose of the Senior Specialist QA role is to act as a pivotal member of the R&D Quality Compliance team, spearheading and aiding initiatives that maintain, improve, and ensure ongoing compliance. This role is a crucial component of the Research & Development (R&D) Quality Compliance team. The R&D Quality Compliance team is a subset of the Strategic Quality Systems and Compliance department, which falls under the broader Division Quality Assurance. The chief responsibility of the Research & Development (R&D) Quality Assurance Compliance team is to manage and ensure compliance across the R&D organization. This includes providing support to various departments such as Global Analytical & Food Safety, Product Development, Laboratory Operations, Micro Operations, Test Method Validation, and other cross-functional areas.

What Youâll Work On

Maintain effectiveness of the R&D quality system

  • Ensure R&D quality system compliance via key program management, internal auditing, validation change control, documentation management and metrics tracking.
  • Understand and apply quality system requirements (e.g., Abbott and ISO/IEC 17025)
  • Provide practical guidance on management of quality system requirements to R&D

Manage Global Control Sample & Reference Standard Program

  • Collaborate with cross-functional groups for new control material qualification.
  • Manage Control Sample & Reference Standard sample inventories. 
  • Global distribution of samples
  • Conduct periodic meetings for inventory review/future planning of new control material.

M-Files Validation Change Control Administration

  • Review validation change requests to ensure compliance with division and department validation requirements.
  • Timely closure of validation change requests
  • Asset & method subject catalog maintenance
  • Metric generation

Audit Support â Internal (R&D) & External (TPLs)

  • Lab audit prep / doc request
  • Audit follow-ups Qualification of third-party testing laboratories (analytical and microbiological)
  • Support lab qualification and requalification audits

Other Responsibilities

  • MAXIMO Calibration out of tolerance report management
  • Assist in the development and implementation of Compliance improvement projects.
  • Third Party Lab process improvements
  • Audit Readiness support

Accountability/Scope

  • Responsible for timely project completion.
  • Work independently to meet project timelines and goals.
  • Summarize procedures, data & information to formulate conclusions.
  • Work collaboratively across groups to meet compliance performance objectives.
  • Actively assume roles of responsibility, such as training or document control.


EDUCATION AND EXPERIENCE, YOUâLL BRING  

Required:

  • Bachelorâs degree in science
  • 7-10 years of experience in laboratory, quality auditor or quality systems role

Preferred

  • Sound knowledge of lab validation (analytical, micro, instrument, methods) principles & application
  • Project management experience
  • Certified auditor from an accredited organization, desirable
  • Experience with summarizing and presenting data both internally & externally.
  • Excellent communication skills.
  • Train others on quality system and compliance processes and requirements

MISC

  • ability to Lift 50 Lbs. or more â 20-25 % of the time.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $72,700.00 â $145,300.00. In specific locations, the pay range may vary from the range posted.

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