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Sr. Specialist Quality Assurance (QA)

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Amgen

1mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Hyderabad, +1

AI generated summary

  • You need a Bachelor's in computer science, 5+ years in QA, 10 years with SAP, deep knowledge of quality data, problem-solving skills, and ability to interpret GLPs, GCPs, and GMPs.
  • You will manage SAP Quality Master Data, guide disposition processes, approve access and documents, resolve production issues, support audits, and ensure compliance with regulatory standards.

Requirements

  • Bachelor’s degree in computer science or related field and 5+ years of Software and Systems Quality assurance experience
  • 10 years of demonstrated ability working directly with SAP and performing business assessments related to system changes
  • Deep Technical knowledge of SAP, SAP disposition functions, and Quality Master Data in SAP
  • Experience owning and serving as QA Contact for Major and Minor Deviations
  • Ability to interpret and apply GLPs, GCP’s and GMPs
  • Knowledge of industry and business principles
  • Demonstrated problem solving abilities
  • Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
  • Provides training and guidance to others
  • Extends capabilities by working closely with senior staff/ experts within and outside the internal organization

Responsibilities

  • Serve as Subject Matter Expert for disposition QA roles, disposition transactions, and Quality Master Data in SAP. Provide assessment, guidance, review, and approval for disposition processes and Quality Master Data in SAP to ensure completeness and accuracy, sound rationale, and alignment to regulatory expectations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and implement necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of deviation requests related to SAP. Participate in and support regulatory inspections.
  • Provide business assessment on impact from SAP system changes related to disposition and Quality Master Data.
  • Provide guidance on setup of Quality Master Data in SAP.
  • Own relevant controlled documents including SOPs, forms, guidelines, and specifications related to SAP functionality, transactions, reports, functionality, and roles.
  • Review operational SOP’s and Work Instructions related to SAP.
  • Approve access for SAP QA Roles from sites and review user access roles to ensure segregation of duties and no excess access.
  • Own SAP QA training material.
  • Initiate, own, or support as QA approver QA Deviations (Major, Minor) and CAPAs as needed.
  • Review and approve Data Integrity Assessments.
  • Support the Global Network for Disposition Process and Global Raw Material Sampling and Inspection.
  • Help to solve production issues related to Quality Master Data, disposition processes, Quality SAP reports, reclassification, sampling, posting of stock, shipments and movement of materials to various stock statuses.
  • Support inspections/audits related to Quality Module and batch numbering scheme in SAP.
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
  • Trend data.
  • Anticipate and prevent potential problems.
  • May be responsible for specific programs and/or projects.
  • Independently develop solutions that are thorough, practical and consistent with functional objectives.

FAQs

What is the main purpose of the Sr. Specialist Quality Assurance (QA) role at Amgen?

The main purpose of the role is to serve as a Subject Matter Expert for disposition QA roles, quality master data in SAP, and to ensure the completeness and accuracy of disposition processes to meet regulatory expectations.

What qualifications are required for this position?

A Bachelor’s degree in computer science or a related field, along with 5+ years of Software and Systems Quality Assurance experience, and 10 years of demonstrated ability working directly with SAP.

What experience is necessary in relation to SAP?

Candidates should have deep technical knowledge of SAP, including SAP disposition functions and Quality Master Data in SAP, along with experience in performing business assessments related to system changes.

What types of deviations will the Sr. Specialist QA be responsible for?

The role requires owning and serving as the QA contact for both Major and Minor Deviations, as well as supporting CAPAs (Corrective and Preventive Actions).

Will the role involve training others?

Yes, the role includes providing training and guidance to others within the team and supporting their professional development.

What types of processes will the Sr. Specialist QA participate in and support?

The role involves participating in and supporting regulatory inspections, addressing production issues related to Quality Master Data, and supporting the Global Network for Disposition Processes and Global Raw Material Sampling and Inspection.

Is there a focus on data integrity in this position?

Yes, the Sr. Specialist QA will be responsible for reviewing and approving Data Integrity Assessments.

How does Amgen approach professional growth and well-being for employees?

Amgen supports professional growth and well-being through competitive benefits and a collaborative culture, ensuring the journey of employees is supported at every step.

Is there a collaborative culture at Amgen?

Yes, Amgen prides itself on an award-winning culture that is collaborative, innovative, and science-based.

What areas of therapeutic focus does Amgen specialize in?

Amgen focuses on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease.

What is the company’s commitment to diversity and inclusion?

Amgen is dedicated to fostering an inclusive environment that respects and values diversity, considering all qualified applicants for employment without regard to various protected statuses.

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Amgen

#WeareBiotech

Science & Healthcare
Industry
10,001+
Employees
1980
Founded Year

Mission & Purpose

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.