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Quality Assurance Scientist

LOCATION: 

Germantown, MD, US

JOB CATEGORY:  R&D
REQUISITION NUMBER:  199174

A mutually rewarding experience.

Work. Realize your ambitions. And realize there’s more to being in business than just making a profit. That’s the Mars philosophy. And the opportunity we offer every one of our Associates. An opportunity to take what you do and make it mean more for you, for those around you and for the planet.  What you get here is challenging, interesting work. You get the tools you need to do a great job and you get to have the best possible people on your side to help you do it. And at the same time as getting to find ways to do business better today than we did it yesterday and driving a great career, you also get to build a more enlightened business and drive sustainability.

Because it’s never just about a single person, a single project or a single brand. It’s about how you can grab everything that’s within your reach here and use it to pursue mutual, long-term gain. It’s about having ideas. And ideals. Being prepared to risk failure because the promise of success means we’ll all be a little better off. It’s that mix of integrity and ambition that makes Mars such a special place to work. And why working here is always about more than just a job.

About Mars, Incorporated 

Mars is a family-owned business with more than a century of history making diverse products and offering services for people and the pets people love. With almost $35 billion in sales, the company is a global business that produces some of the world’s best-loved brands: M&M’s®, SNICKERS®, TWIX®, MILKY WAY®, DOVE®, PEDIGREE®, ROYAL CANIN®, WHISKAS®, EXTRA®, ORBIT®, 5™, SKITTLES®, UNCLE BEN’S®, MARS DRINKS and COCOAVIA®. Mars also provides veterinary health services that include BANFIELD® Pet Hospitals, Blue Pearl®, VCA® and Pet Partners™. Headquartered in McLean, VA, Mars operates in more than 80 countries. The Mars Five Principles – Quality, Responsibility, Mutuality, Efficiency and Freedom – inspire its more than 100,000 Associates to create value for all its partners and deliver growth they are proud of every day.

 

Job Title              Quality Assurance Scientist

Reports to           Food Safety and Quality Manager

Segment              Mars Symbioscience

Function              Quality

Location/Site      Germantown, MD / GMD

 

Overview

This position works in the area of Quality and Food Safety and provides support in developing, implementing, maintaining, and proactively improving quality management programs, methods, and systems to assure product, processes, and environments conform to the established Mars quality and regulatory standards, with a focus on internal processes, data review, and data management. There is a close working relationship with R&D, Supply, and external manufacturing partners. The position promotes product safety and general product quality awareness with the opportunity to grow further in the Quality and Food Safety function. Quality assures all relevant materials released by Mars Symbioscience conform to FDA requirements defined in 21 CFR 117, 111, & 11.

 

Principal Accountabilities

  • Perform data review and data management for quality-related projects.
  • Perform release for raw materials and finished products in accordance with internal processes and FDA 21 CFR part 117, 111, & 11. (Certificate of Analysis (CofA) data review & release)
  • Perform evaluations and make disposition decisions for raw materials, intermediates/work-in-progress materials (WIP), finished products, and labelling through timely evaluation of laboratory results, and other cGMP documents.
  • Investigate and assess impact of minor and major deviations and nonconformance’s that may occur during manufacturing, storage, shipment, and/or testing of products.
  • Manage retention samples required by regulatory authorities, customers, and business unit and ensure quality control for product destructions.
  • Perform set up, review, and close out of raw material and finished product stability studies.
  • Support Laboratory Compliance as necessary.
  • Perform review and approval of scientifically valid method verification and validations.
  • Perform tracking and trending of data
  • Comply with all pertinent SOPs to complete documentation for Corrective Actions and Preventative Actions (CAPA’s), deviations, and non-conforming materials.
  • Own CAPA system, drive closures of CAPA’s and inform Quality & Food Safety Manager of escalations.
  • Lead Quality Assurance Change Management Process.
  • Manage document control and record retention system.
  • Write and review SOPs and related quality documents.
  • Supports, reviews, and/or approves creation of documentation standards, such as protocols, reports, procedures, material specifications, customer documentation, and product labelling.
  • Fosters interactions among functional groups for overall quality improvement, maintains good working relationships with other departments, and assists Associates in the understanding and implementation of quality initiatives, standards, and applicable regulations.
  • Represents Quality Assurance on cross-functional teams.
  • Informs line manager on the quality and compliance status of quality activities.
  • Supports internal audit program as necessary.
  • Supports external audit readiness as necessary.
  • Ensures all quality-related work is performed and documented in accordance with cGMP requirements and existing company policies and procedures.
  • Lead Product-Related Incident Management Process (PRIMP) documentation and support resolution.
  • Witness food safety related destructions as necessary.
  • Provide leadership in coordinating problem solving activities as needed to resolve issues.
  • Support Food Safety and Quality Manager with Management review activities.
  • Other duties as required.

 

Key Functional Competencies and Skills

  • Strong questioning and probing skills to discover root causes and to verify the accuracy of information, results, and data.
  • Prior experience with CAPA’s, root cause analysis, and QMP systems is required
  • Prior experience in a cGMP facility is required
  • Prior experience performing chemical and physical testing and sampling of raw materials and finished products is preferred.
  • Proven application of laboratory methodologies, statistics, and, quality tools
  • Demonstrated experience in being able to work independently and cooperatively with a team.
  • Excellent ability to use and learn new software systems including: word processing, spreadsheets, ETQ Reliance (quality management software), and graphics.
  • Ability to work with others in R&D, Commercial, Marketing, and/or Distribution to improve product, processes, and systems.
  • Strong command skills and interpersonal skills with the ability to communicate effectively.
  • Flexibility to adapt to new priorities and quality issues.
  • Ability to handle sensitive information.
  • Ability to adhere to tight deadlines.
  • In-depth knowledge of FDA GMP requirements for dietary supplements.

 

Educational and Professional Qualifications

  • B.S. degree in the Sciences, such as Chemistry, Engineering, Statistics, Food Science, or related field (Biological, Food Technology, Biotechnology, Mathematics).
  • At least 4 years in regulated industry required with direct experience in Quality Assurance/Quality Control, along with at least 2 years’ practical experience in laboratory working with established GMP and/or ISO quality systems.
  • Proven application of data review, including laboratory methodologies, notebooks, statistics, and/or quality tools.

 

Travel

  • Up to 20% domestic travel.

 

Mars 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 status, protected veteran status, or any other characteristic protected by law. If you need assistance or an accommodation during the application process because of a disability, it is available upon request. The company is pleased to provide such assistance, and no applicant will be penalized as a result of such a request.

 


Nearest Major Market: Washington DC

Job Segment: Scientific, Chemical Research, CAPA, Engineer, Quality Assurance, Engineering, Management, Technology