Quality Complaints Senior Associate - Biopharma (JP8099)
Thousand Oaks, CA (Remote until Convid-19 restrictions are lifted)
: 12 months with likely extensions
3 Key Consulting is hiring a Sr Associate Quality Complaints
position for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Initiate and coordinate product complaints. Interface with call centers, various company sites and business partners to ensure call intake process compliance.
- Complete and approve product complaints requiring no further investigation.
- Reconcile reported product complaints to ensure entry in CMIS.
- Perform return sample coordination and visual assessment.
- Archive documents related to product complaints. Evaluate documentation and operation and documentation according to company guidelines.
- Be self-motivated, attentive to details and able to prioritize and meet deadlines.
- Basic statistical mathematical skills including the ability to trend data.
- Basic project management skills. Independently understand, follow and implement instructions. Strong word processing, database and spreadsheet application skills.
- Strong organizational skills with the ability to manage multiple projects or assignments.
Bachelor's Degree in Life Sciences or related field or the equivalent combination of education and/or experience. Typically, 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry.
Top Must have Skill Sets:
- Prior quality experience
- Strong computer skills (Microsoft)
- Good communication skills
- Good organizational skills
Employee Value Proposition:
- Triage incoming complaint records by reviewing information, assigning complaint codes and assessments, and determining if further information is required.
Understand basic device operation to determine complaint codes.
- Coordinate/follow-up with other departments for required information.
- Ensure fields are populated correctly. Manage workload to ensure timeframes are met.
Good understanding over the overall complaints system.
Phone screen then panel WebEx/Skype interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.