Associate- Quality Complaints
Amgen
Associate- Quality Complaints
Job Description
Career CategoryQualityJob DescriptionJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.What you will doLet’s do this. Let’s change the world. In this vital role you will own 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 Associate conducts complaint investigation tasks related to customer feedback records and records with limited information available, as well as records that might not require any investigation. The Associate also determines if complaint investigations require critical issue for further higher level investigation.Evaluates and ensures triaged product complaint records stay in sync with applicable proceduresEvaluates and manages customer feedback records to closureEvaluates records that have been determined to be voided and completes the void processOwns records with limited informationCompletes assigned assessments per applicable proceduresEnsures quality of complaint recordsDrives the complaint process per SOP requirementsOwns or handles the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guideSupports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenanceWhat we expect from youWe are all different, yet we all use our unique contributions to serve patients.Basic Qualifications:Bachelor’s degree and 2 to 4 years of in Pharma/Life Sciences/BiotechnologyORMaster’s and 1- 3 years of in Pharma/Life Sciences/Biotechnology ExperiencePreferred Qualifications:Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industryAbility to successfully manage workload to timelinesAbility to operate in a matrixed or team environment with site, functional, and senior management leadershipUnderstanding of quality and industry requirements/expectations of a QMSUnderstanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reportsPractical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel)Verbal and written communication skills/writing skillsTechnical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies.Active listening skillsAbility to understand and follow processes / process instructionsAttention to detailWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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, disability status, or any other basis protected by applicable law.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..
Locations
- India - Hyderabad
Skills Required
- biotechintermediate
- and knowledge of MS Office Applicationsintermediate
- MS Office Applicationsintermediate
Required Qualifications
- Owns or handles the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide (experience)
- Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance (experience)
- Bachelor’s degree and 2 to 4 years of in Pharma/Life Sciences/Biotechnology (experience, 4 years)
- Bachelor’s degree and 2 to 4 years of in Pharma/Life Sciences/Biotechnology (experience, 4 years)
- Master’s and 1- 3 years of in Pharma/Life Sciences/Biotechnology Experience (experience, 3 years)
- Master’s and 1- 3 years of in Pharma/Life Sciences/Biotechnology Experience (experience, 3 years)
Preferred Qualifications
- Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry (experience)
- Ability to successfully manage workload to timelines (experience)
- Ability to operate in a matrixed or team environment with site, functional, and senior management leadership (experience)
- Understanding of quality and industry requirements/expectations of a QMS (experience)
- Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) (experience)
- Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reports (experience)
- Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel) (experience)
- Verbal and written communication skills/writing skills (experience)
- Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies. (experience)
- Active listening skills (experience)
- Ability to understand and follow processes / process instructions (experience)
- Attention to detail (experience)
- Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry (experience)
- Ability to successfully manage workload to timelines (experience)
- Ability to operate in a matrixed or team environment with site, functional, and senior management leadership (experience)
- Understanding of quality and industry requirements/expectations of a QMS (experience)
- Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) (experience)
- Accurate utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reports (experience)
- Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel) (experience)
- Verbal and written communication skills/writing skills (experience)
- Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies. (experience)
- Active listening skills (experience)
- Ability to understand and follow processes / process instructions (experience)
- Attention to detail (experience)
Responsibilities
- Let’s do this. Let’s change the world. In this vital role you will own 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 Associate conducts complaint investigation tasks related to customer feedback records and records with limited information available, as well as records that might not require any investigation. The Associate also determines if complaint investigations require critical issue for further higher level investigation.
- Evaluates and ensures triaged product complaint records stay in sync with applicable procedures
- Evaluates and manages customer feedback records to closure
- Evaluates records that have been determined to be voided and completes the void process
- Owns records with limited information
- Completes assigned assessments per applicable procedures
- Ensures quality of complaint records
- Drives the complaint process per SOP requirements
- Owns or handles the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
- Supports management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance
- Evaluates and ensures triaged product complaint records stay in sync with applicable procedures
- Evaluates and manages customer feedback records to closure
- Evaluates records that have been determined to be voided and completes the void process
- Owns records with limited information
- Completes assigned assessments per applicable procedures
- Ensures quality of complaint records
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