ThousandOaksRecruiter Since 2001
the smart solution for Thousand Oaks jobs

Specialist Quality Complaints

Company: Amgen
Location: Thousand Oaks
Posted on: January 13, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Specialist Quality ComplaintsLiveWhat you will doLets do this. Lets change the world.Amgen is seeking a Specialist Quality Complaints Level 2 / Level 3 Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.The Specialist conducts complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution.Key Responsibilities:Ensures quality of complaint recordsApplies analytical skills to evaluate complex situations using multiple sources of informationImplementation of regulatory and SOP requirementsAnticipates and prevents potential issues with regulatorsProvides guidance and technical adviceEvaluates subject matter expert assessmentsRaises potential Quality issues to ManagementWinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.Basic Qualifications:Doctorate degreeOrMasters degree & 3 years of Quality / Manufacturing experienceOrBachelors degree & 5 years of Quality / Manufacturing experienceOrAssociate's degree and 10 years of Quality / Manufacturing experienceOrHighschool diploma / GED and 12 years of Quality / Manufacturing experiencePreferred Qualifications4+ years of quality and manufacturing experience in biotech or pharmaceutical industryBachelors Degree in a Science FieldAbility to oversee multiple projects simultaneouslyAbility to successfully manage workload to timelinesFamiliarity with basic project management toolsAbility to negotiate a position after taking feedback from multiple sourcesDemonstrated ability to consistently deliver on-time, and high-quality resultsAbility to operate in a matrixed or team environmentUnderstanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)Ability to travel +/- 10% of time to domestic and international Amgen sitesThriveSome of the vast rewards of working hereAs we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comJoin UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Keywords: Amgen, Thousand Oaks , Specialist Quality Complaints, Other , Thousand Oaks, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Thousand Oaks RSS job feeds