Posted on: Aug.2021
Specialist Quality Assurance
US - California - Los Angeles
US - Rhode Island - West Greenwich
US - Kentucky - Louisville/Jefferson County
US - Massachusetts - Cambridge
US - Colorado - Boulder
The Specialist Quality Assurance will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will monitor validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.
This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.
Responsibilities:
Serve as Owner or QA Contact for Minor and Major Deviations. Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. 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 enforce necessary improvements and corrections to established systems and processes. Initiate, execute, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.
-Review and Approve Requirement Specifications, Design Specification, Testing Protocols, Validation Plans, Summary -Reports, and Trace Matrixes
-Initiate and own QA Deviations (Major, Minor) as needed
-Act as reviewer and approver for operational and administrative SOP’s and Work Instructions
-Review of operational SOP’s and Work Instructions
-Review and approve Change Controls
-Review and approve Data Integrity Assessments
-Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
-Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
*Qualitative information
*Quantitative research
*Trend data
Forecasts, models and utilizes advanced analytical tools
Anticipates and prevents potential problems
May be responsible for specific programs and/or projects
Independently develops solutions that are thorough, practical and consistent with functional objectives
Responsibilities:
Serve as Owner or QA Contact for Minor and Major Deviations. Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. 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 enforce necessary improvements and corrections to established systems and processes. Initiate, execute, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.
-Review and Approve Requirement Specifications, Design Specification, Testing Protocols, Validation Plans, Summary -Reports, and Trace Matrixes
-Initiate and own QA Deviations (Major, Minor) as needed
-Act as reviewer and approver for operational and administrative SOP’s and Work Instructions
-Review of operational SOP’s and Work Instructions
-Review and approve Change Controls
-Review and approve Data Integrity Assessments
-Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
-Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
*Qualitative information
*Quantitative research
*Trend data
-Forecasts, models and utilizes advanced analytical tools
-Anticipates and prevents potential problems
-May be responsible for specific programs and/or projects
-Independently develops solutions that are thorough, practical and consistent with functional objectives
Basic Qualifications
Doctorate
OR
Master’s degree and 2 years of experience
OR
Bachelor’s degree and 4 years of experience
OR
Associates’ degree and 10 years of experience
OR
High School Diploma/ GED and 12 years of experience
Preferred Qualifications
-Bachelor’s degree in Computer Science or related field and 5+ years of Software and Systems Quality assurance experience
-Experience owning and serving as QA Contact for Major and Minor Deviations
-Technical knowledge of IS systems such as LIMS, CDOCS, SAP, Maximo
-Ability to interpret and apply GLPs, GCP’s and GMPs
-Broad technical knowledge within own specialty area
-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
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.