Complaint Specialist
12500 Whitewater Drive Minnetonka, MN 55343 US
Job Description
*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.
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EDUCATIONAL REQUIREMENTS (degree, license, certification):
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- Bachelor’s Degree in the Sciences or related field is required or equivalent work experience
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YEARS OF EXPERIENCE:
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- 1 or more years in product complaint investigation experience.
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OTHER SKILLS AND ABILITIES:
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- 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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