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Quality and Compliance

Ready to make a meaningful impact in Quality and Compliance? Join us in shaping the standards that drive industries forward and ensure the highest levels of safety and excellence. This thriving sector offers not only a chance to be at the forefront of innovation but also the satisfaction of knowing your work directly impacts society. Explore our job opportunities for a chance to grow in a field that values dedication, precision, and commitment to excellence. Start your journey towards a fulfilling career today with us.

Complaint Specialist

Minnetonka, MN 55343

Posted: 03/18/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 602250 Is job remote?: No Country: United States

Job Description

Target PR Range: 35-45/hr
*Depending on exp
Job Description:
  • Conducting complaint investigations and associated tasks to ensure complaint investigations are thorough, investigation conclusions are appropriate, appropriate procedures are followed, and complaint investigations are conducted and closed in a timely manner.
  • Reviewing & identifying the root causes of complaints and works with the applicable operational departments such as: Product Development, Manufacturing Engineering, and Quality Engineering to ensure an appropriate resolution.
  • Responding directly to customers to investigate and resolve complaints, when necessary.
  • Assisting in the development of training materials and process enhancements related to complaints management.
  • Facilitating complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection/investigation, as needed.
  • Participate in quality management system meetings regarding complaints and complaint handling.
  • Performing duties in accordance with the Company’s Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.
  • Providing input to support the continual improvement of complaint handling processes.
  • Performing other related duties as assigned.

 

EDUCATIONAL REQUIREMENTS (degree, license, certification):

 
  • Bachelor’s Degree in the Sciences or related field is required or equivalent work experience

 

YEARS OF EXPERIENCE:

 
  • 1 or more years in product complaint investigation experience.

 

OTHER SKILLS AND ABILITIES:

 
  • Strong computer skills.  Proficiency with Microsoft Office business software and use of information databases
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Proven ability to communicate effectively; orally and written
  • Ability to manage multiple tasks and projects
  • Able to work independently, as well as in a cross-functional team environment
  • Customer service oriented attitude and ability to exercise sound business judgment
  • Ability to maintain confidentiality and discretion in business relationships
  • Able to define problems, organize and collect data, establish facts, and draw valid conclusions
  • Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus
  • Travel between sites as needed


 
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