Amgen Specialist Quality Control Vacancy – Life Science, Biology
Amgen job opening 2022. Specialist Quality Control job opening 2022, Specialist Quality Control post vacancy for the candidates who have bachelor’s degree in life science, biology, , biochemistry, molecular science, and genetics candidates. Intrested and eligible candidates may check out all the details on the same below:
Job Title: Specialist Quality Control
Location: US – California – Thousand Oaks
Eligibility Criteria:
They are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control professional we seek will have these qualifications:
Doctorate degree OR Masterโs degree and 3 years of Quality Control and/or Laboratory experience in GMP regulated environment Or Bachelorโs degree and 5 years of Quality Control and/or Laboratory experience in GMP regulated environment Or
Associateโs degree and 10 years of Quality Control and/or Laboratory experience in GMP regulated environment Or High School Diploma/GED and 12 years of Quality Control and/or Laboratory experience in GMP regulated environment
Preferred Qualifications
- Degree in Life Science including but not limited to: Biology, Immunology, Genetics, Biochemistry, and Molecular Sciences or other related fields
- Experience with cGMP Production environments and an understanding of its regulatory requirements
- Experience with TrackWise for supporting documentation of Deviation investigations, Analytical Result Assessment investigations, CAPAs, and Change Control records
- Experience with cell-based analytical techniques, cell culture and maintenance, and aseptic techniques
- Experience participating in, and responding to corporate audits/regulatory inspections
- Knowledge of method transfer and validation activities
- Knowledge of Operational Excellence tools
- Experience working effectively with diverse teams
Desired skills/behaviors include:
- Clear and concise technical writing
- Project management skills
- Organizational skills and ability to multitask and prioritize in a dynamic environment with minimal direction
- Analysis of complex problems and delivery of clear recommendations
- Strong interpersonal skills
- Ability to clearly communicate the status of the investigation to leadership and to auditors and inspectors
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
- Analysis of complex problems and delivery of clear and timely feedback
- Strong interpersonal skills
Job Description
Youโve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youโve worked hard to acquire and the passion you already have. At Amgen, our shared missionโto serve patientsโdrives all that we do. It is key to our becoming one of the worldโs leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
In this vital role as Quality Control Specialist in the Amgen thousand Oaks (ATO) QC Bioassay team, you will be responsible for managing analytical method co-validation and transfer initiatives, providing technical expertise to the team for resolution of issues and continuous improvement, facilitating the achievement of release and stability testing timelines through approval of assays, and ownership of technical records pertaining to investigations and documentation in support of analytical testing.
Specific responsibilities include but are not limited to:
- Coordination of method co-validation and transfer activities in the laboratory
- Ownership of analytical methods
- Approval of assays to support testing due dates
- Critical reagent management, and supporting documentation
- Provision of expertise and input to issues observed in the laboratory
- Participation in corporate audits and regulatory inspections, representing the QC Bioassay area
- Ownership of Analytical Result Assessments, deviation records and change control records pertaining to QC Bioassay
- In-depth knowledge of QC Laboratory working principles, Good Documentation and Manufacturing Practices (GDP and GMP).
- Identifying opportunities and driving initiatives to reduce error, gain laboratory efficiency, and reduce cycle time
- Understanding and use of laboratory electronic systems and Quality systems.
- Participating in network technology excellence team meetings
Amgen Specialist Quality Control