Location
Minnetonka, MN | United States
Job description
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed manufactured and distributed to the highest standards in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America Europe Asia and the Middle East we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multicultural team PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such you will not only be offered compensation and benefits structure that rewards you but also be provided with the tools that will help you grow and learn.
At PSC Biotech it s about more than just a job it s about your career and your future.
Your Role
We are hiring a Complaints Investigator. This is a 6month onsite contract position with possible extension.
- Conduct thorough investigations of complaints related to combination drug products and devices.
- Collaborate with crossfunctional teams to gather relevant information and data for comprehensive investigations.
- Maintain detailed and accurate records of complaint investigations ensuring compliance with regulatory standards.
- Prepare detailed and timely reports on complaint investigations summarizing findings root cause analysis and proposed corrective actions.
- Work closely within QC lab to execute testing and analysis of complaint samples.
- Drive and ensure timely manner of complaint investigation and closure.
- Collaborate closely with crossfunctional teams including product development manufacturing engineering quality etc. to ensure appropriate resolution.
- Provide excellent customer service communicating with customers to investigate and resolve complaints when required.
- Support ongoing training developing materials and identifying opportunities for process improvement within the complaints handling and investigation process.
- Attend meetings including quality system regarding complaint handling.
- Ensure compliance with internal standards and industry regulations at all times.
- Additional responsibilities as needed.
Requirements
- Bachelors degree in relevant discipline or equivalent work experience.
- 25 years of direct product complaints investigation experience.
- Strong knowledge of regulatory requirements and quality standards.
- Excellent computer skills for data entry and documentation. Familairty with eQMS systems is a plus.
- Detailoriented and able to manage multiple tasks simultaneously.
- Effective communication skills with the ability to convey complex information clearly and concisely.
- Excellent analytical and problemsolving skills.
- Background in manufacturing processes for sterile pharmaceutical products and drugdevice combination products is a plus.
- Must be able to work onsite fulltime.
#LIRW1
Bachelor\'s degree in relevant discipline or equivalent work experience. 2-5 years of direct product complaints investigation experience. Strong knowledge of regulatory requirements and quality standards. Excellent computer skills for data entry and documentation. Familairty with eQMS systems is a plus. Detail-oriented and able to manage multiple tasks simultaneously. Effective communication skills with the ability to convey complex information clearly and concisely. Excellent analytical and problem-solving skills. Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products is a plus. Must be able to work on-site full-time. #LI-RW1
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