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External Mfg Quality Manager

Job Advert

Want to take manufacturing to the next level? As External Mfg Quality Manager you’ll have the freedom to take ownership and help set the standard excellence at our site.

 

External Mfg Quality Manager

 Salt Lake City, UT

Competitive Salary & excellent benefits package

 

Quality counts here. You’ll ensure that all products supplied by external manufacturing organizations (EMO's) in North America meet the appropriate standards of quality. You'll support and manage projects where product is to be manufactured at an EMO, and you'll provide support to RB sites manufacturing product for import to US on all matters relating to GMP and FDA inspections.

 

You’ll succeed because…

…you’re committed to quality. You’ve a background in quality control or assurance, ideally in healthcare or a regulated manufacturing environment. You work best autonomously, taking ownership and initiative for your own results. You understand quality controls, technical manuals and process improvements. You’re diplomatic and tactful, meaning you can facilitate change and improve working practices and processes. You collaborate effectively and lead improvement.

 

You’ll love it because…

…you’ll have the freedom to make a difference. You’ll put your own ideas into practice. The products you help us get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Responsibilities
  • Maintain the quality management system of the EMO group. This includes assuring that all product specifications and all regulatory requirements have been satisfied prior to the final release of any product into the distribution channel.
  • Develop and work with the External Manufacturing Partners for prompt action(s) for timely resolution and follow through to completion.
  • Work closely with the Quality Release teams based in the LC’s, PA to ensure that all batches of EMO manufactured product are released according to FDA requirements for sale in the US.
  • Approve GMP documentation in a timely manner such as change control and validation for EMO products prior to release.
  • Generation of Quality Documentation including Technical Agreements and Technical Manuals to support production at external manufacturers.
  • Manage and resolve 3rd party quality complaints including trend analysis, and corrective and preventive actions as deemed appropriate.
  • Support ongoing New Product Development and Existing Product Development projects as the Quality lead.
  • Audit External Manufacturers based in North America.
  • Establish and maintain a robust EMO approved process and work with EMO’s to remediate to the required RB standard where necessary.
  • Deliver EMO metrics and ensure monthly global reporting.
  • Lead the Critical Event Process (CEP) for any products found to be out of compliance and released to market.

 

Qualifications
  • Bachelor’s degree in a scientific or technical field such as Chemistry, Chemical Engineering, Industrial Engineering, Mechanical Engineering, or Manufacturing Engineering.
  • Candidate shall have 5-8 years of quality assurance work experience in a Pharmaceutical/Medical device or Dietary Supplement industry.
  • Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers.
  • Demonstrated ability to manage and coordinate the execution of multiple complex projects in a fast-paced environment.
  • Must have a strong working knowledge of applicable parts of Title 21 of the CFR, ICH, and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical, medical device, or dietary supplement industry.
  • Experience using electronic quality management tools such as TrackWise is a PLUS.
  • Experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem-solving teams, etc.
  • Must exhibit excellent communication and facilitation skills, both oral and written.
RB Benefits

RB provides excellent benefits and competitive salaries!

  • 4 Weeks Paid Vacation
  • 2 Volunteer Days
  • Annual Merit and Bonus Programs
  • Medical, Dental, Vision
  • 401k with Match
  • HSA (Up to $1000 Annual Company Contribution)
  • Excellent Maternity Leave/Paternity
  • Free Formula for infants up to 1 year's old
  • Milk Stork provided to nursing moms
  • Employee Assistance Program
  • Free Onsite Gym
  • Onsite Quite Rooms
  • Onsite Employee Store -
    • Purchase popular brands like Lysol, Finish, Airborne, etc. at low cost! 
  • Free beverage (Coffee, Tea, Soda) stocked in all breakrooms
  • Avenue C Market onsite in breakrooms
  • Yearly Lagoon Company Party
  • And there is much more!
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.

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