Senior Associate Quality Control – Swing Shift 2PM-11PM

Category: Quality
Job ID: R-42680
Location: US – California – Thousand Oaks
Posted Date: August 11, 2017
The Sr. Associate Quality Control will primarily support the QC Microbiology and Analytical Chemistry Laboratories by performing testing and data review/approval for time sensitive assays such as Bioburden testing, PCR (Mycoplasma and Minute Mouse Virus), Biological Indicators and HPLC. You may support testing for additional Microbiology and Chemistry related assays. The Sr. Associate will also perform sample management activities such as sample processing and sample pick up at the various Manufacturing buildings.

Candidates interested in this position are will work a swing shift (2pm-11pm) which will include one weekend day (Tuesday-Saturday shift or Sunday-Thursday shift).

Key Responsibilities:
Perform analytical testing in accordance with established Analytical Methods and Standard Operating Procedures
Report, evaluate, trend and approve analytical data
Troubleshoot, solve problems and communicate with stakeholders
Respond to Critical Equipment Monitoring System alarms
Generate complete, accurate, and concise documentation using electronic systems and laboratory notebooks
Participate in audits, initiatives, and projects that may be departmental or organizational in scope
Evaluate lab practices for compliance and operational excellence improvement on a continuous basis
Participate in lab investigations
Conduct training for new and existing staff
May represent the department/organization on various teams

Basic Qualifications
Master’s degree
Bachelor’s degree and 2 years of Quality Control experience
Associate’s degree and 6 years of Quality Control experience
High school diploma / GED and 8 years of Quality Control experience

Preferred Qualifications
cGMP Experience
Experience with Microbiology testing techniques such as Membrane Filtration
Experience and training in aseptic technique
Experience with Polymerase Chain Reaction
Experience using Laboratory Information Management Systems
Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation
Experience using Chromatography Data Systems, such as Empower
Experience and knowledge of Data Integrity Requirements of QC Systems
Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
Excellent problem-solving capabilities and attention to detail
Experience of collaboration within and across functional areas and outstanding customer service focus
Excellent written and verbal communication skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status.

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