Sr Associate Quality Complaints – Biopharma (JP5153)
Thousand Oaks, CA.
1 year with likely extension
3Key Consulting Inc. is recruiting for an Sr. Associate Quality Complaints
with Experience in managing complaint related to biologics, medical devices and solid dose products, for a global, CA-based, bio-pharmaceutical company.
Initiate and coordinate product complaints. Interface with call centers, various Amgen 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 product complaint database. Perform return sample coordination and visual assessment. Archive documents related to product complaints.
Top Must-Have Skills:
- 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.
- 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.
Day to Day Responsibilities:
- General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals
- Experience in managing complaint related to biologics, medical devices and solid dose products
- Candidate must have proven computer literacy as well as independently understanding, following and implementing instructions.
- Candidate must be well-organized, possess excellent oral and written communication skills, and have the ability to function in a fast paced environment. In addition, must be able to work independently or as a team player and collaborate with outside resources
Employee Value Proposition:
- Interact and communicate with internal and external customers for reporting of complaints and adverse events (this may include intake and/or follow –up requests for information)
- Ensure that all complaints requiring customer responses are properly addressed as assigned
- Understands the complaint handling process from initiation to closure
- Process and close complaints in a timely manner
- Maintain current knowledge of the Regulatory regulations
- Serves as an internal review in order to assure regulatory compliance across all product lines
- Other duties as assigned
Opportunity to understand the quality systems of complaints and how it impacts drug product
- Lack of GMP/GXP
- Lack of Quality experience
Phone followed by in-person
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this position, please feel free to look at the 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.