Senior Associate Quality Complaints - Combination Drug Device (JP4644)
Thousand Oaks, CA.
months with likely extension
3Key Consulting Inc. is recruiting for a Senior Associate Quality Complaints
with 3 - 5 years’ experience in managing complaints related to biologics, medical devices and solid dose products within a cGMP/GxP environment for a global, CA-based, bio-pharmaceutical company.
Candidate will perform the following functions:
Top Must-Have Skill Sets:
- 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.
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.
- Must be able to work independently or as a team player and collaborate with outside resources.
- 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 to assure regulatory compliance across all product lines.
- Other duties as assigned.
Why This Position Is Open:
- 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.
Supplement additional workload on team.
Employee Value Proposition:
Opportunity to understand the quality systems of complaints and how it impacts drug product.
- Lack of GMP/GXP.
- Lack of Quality experience
Phone, then in-person if needed.
We invite qualified candidates to send your resume to email@example.com
. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.