Senior Specialist, Quality Systems - Boehringer Ingelheim
Gainesville, GA
About the Job
Description
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Specialist, Quality Systems will administer the site's Training Quality System and associated Learning Management System (LOS/SuccessFactors/Plateau). This role ensures that training is developed and available to support, maintain and continuously enhance capabilities in the organization to comply with all applicable regulatory requirements. This position works with the Operations and Quality management, end users, instructors and other LMS Administrators to plan, organize, and support learning content and events consisting of e-Learnings and instructor-led sessions, and any associated training and learning items. The Senior Specialist, Quality Systems provides guidance on all aspects of Change Control. This role creates/refines change tracking systems and analyze the Change Controls. This individual will disposition Change Controls as appropriate and assure approved change is following corporate requirements and USDA requirements. The incumbent will track and receive change controls from different areas as well as record and maintain change controls and all documentation in the TrackWise system. This role is responsible for following up on overdue and those Change Controls that are coming due to maintain compliance. The incumbent will maintain and track KPIs tied to change management as well as provide updates to management on progress as well as attend Change Control project meetings and provide QA oversight for these Change Controls.
Duties & Responsibilities
+ Participates in the training approach for the site, ensuring all regulations (e.g., USDA) and Company policy and procedure requirements are met.
+ Partners with people leader and subject matter experts to identify training needs and gaps and develop solutions to close these gaps.
+ Influences as a technical resource and departmental SME for Training system related questions and topics.
+ Delivers training on the Training process and system (e.g., LOS).
+ Grants system access to employees as appropriate.
+ Administers the electronic learning management system LMS (e.g., LOS):
+ Creates learning courses, curricula, assignment profiles, manages new and existing user accounts, modifies training due dates.
+ Executes the removal and/or update of training profiles as required by users in the Training System (e.g., LOS).
+ Escalates and liaises with LOS technical experts to resolve and remediate LOS technical issues.
+ Performs/identifies GAP analysis as needed.
+ Works within Quality Systems Team and cross-functionally to remediate and close GAP’s related to learning plans.
+ Delivers technical LMS customer support to site employees through development of local communications and trainings.
+ Provides support of regulatory authority inspections and audits for training topics (preparation, conduct and follow up activities / reporting – as applicable).
+ Performs trending and analysis of site’s Training system performance.
+ Supports Quality Management activities (e.g., metrics, strategic initiatives).
+ Provides input to process improvement initiates to site management on ways to enhance or replace existing training based on role and responsibility.
+ Provides guidance on all aspects of Change Control system for the site.
+ Influences as a technical resource and departmental SME for Change Control system related questions and topics.
+ Trains employees on the Change Control process and system (e.g., TrackWise).
+ Performs trending and analysis of site’s Change Control system performance.
+ Supports Quality Management activities (e.g., metrics, strategic initiatives).
+ Performs review and approval of site Change Controls.
+ Evaluates and determines the Quality Risk associated with each Change Control.
+ Provides QA assessment and approval decision for Change Controls.
+ Tracks and maintains Change Controls in TrackWise system.
+ Follows up on outstanding change controls that have been requested to make sure they get closed out.
+ Follows up with Change Control owners to make sure all new Change Controls are completed on time.
+ Tracks KPIs tied to Change Management and provide updates to department management monthly.
+ Responsible for monitoring projects tied to Change Controls and Training, and attending necessary meetings as required to provide QA input.
+ Assists with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
+ Performs any other assignment related to with Quality Systems responsibilities.
Requirements
+ Minimum of a bachelor’s degree in a science related field with three (3) years of Quality Assurance experience in Animal or Human Biologics or Pharmaceutical manufacturing.
+ Excellent oral and written communication skills.
+ Attention to detail imperative.
+ Organization skills along with ability to manage time and work with little supervision.
+ Ability to teach, coach or assist site regarding various systems.
+ Ability to work cross-functionally and establish effective working relationships with other departments along with working independently, interacting with all levels of management.
+ Decision Making & Delivering Results; analytical thinking.
+ Proficiency with PCs and MS Office applications (i.e., Outlook, Word, Excel) required; familiarity with electronic Training and Change Control systems.
+ Familiar with USDA 9 CFR and cGMP Regulatory requirements.
+ Knowledge of quality assurance processes/systems.
+ Knowledge of and/or experience working in a regulated environment (e.g., USDA, FDA, etc.) is a plus.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Specialist, Quality Systems will administer the site's Training Quality System and associated Learning Management System (LOS/SuccessFactors/Plateau). This role ensures that training is developed and available to support, maintain and continuously enhance capabilities in the organization to comply with all applicable regulatory requirements. This position works with the Operations and Quality management, end users, instructors and other LMS Administrators to plan, organize, and support learning content and events consisting of e-Learnings and instructor-led sessions, and any associated training and learning items. The Senior Specialist, Quality Systems provides guidance on all aspects of Change Control. This role creates/refines change tracking systems and analyze the Change Controls. This individual will disposition Change Controls as appropriate and assure approved change is following corporate requirements and USDA requirements. The incumbent will track and receive change controls from different areas as well as record and maintain change controls and all documentation in the TrackWise system. This role is responsible for following up on overdue and those Change Controls that are coming due to maintain compliance. The incumbent will maintain and track KPIs tied to change management as well as provide updates to management on progress as well as attend Change Control project meetings and provide QA oversight for these Change Controls.
Duties & Responsibilities
+ Participates in the training approach for the site, ensuring all regulations (e.g., USDA) and Company policy and procedure requirements are met.
+ Partners with people leader and subject matter experts to identify training needs and gaps and develop solutions to close these gaps.
+ Influences as a technical resource and departmental SME for Training system related questions and topics.
+ Delivers training on the Training process and system (e.g., LOS).
+ Grants system access to employees as appropriate.
+ Administers the electronic learning management system LMS (e.g., LOS):
+ Creates learning courses, curricula, assignment profiles, manages new and existing user accounts, modifies training due dates.
+ Executes the removal and/or update of training profiles as required by users in the Training System (e.g., LOS).
+ Escalates and liaises with LOS technical experts to resolve and remediate LOS technical issues.
+ Performs/identifies GAP analysis as needed.
+ Works within Quality Systems Team and cross-functionally to remediate and close GAP’s related to learning plans.
+ Delivers technical LMS customer support to site employees through development of local communications and trainings.
+ Provides support of regulatory authority inspections and audits for training topics (preparation, conduct and follow up activities / reporting – as applicable).
+ Performs trending and analysis of site’s Training system performance.
+ Supports Quality Management activities (e.g., metrics, strategic initiatives).
+ Provides input to process improvement initiates to site management on ways to enhance or replace existing training based on role and responsibility.
+ Provides guidance on all aspects of Change Control system for the site.
+ Influences as a technical resource and departmental SME for Change Control system related questions and topics.
+ Trains employees on the Change Control process and system (e.g., TrackWise).
+ Performs trending and analysis of site’s Change Control system performance.
+ Supports Quality Management activities (e.g., metrics, strategic initiatives).
+ Performs review and approval of site Change Controls.
+ Evaluates and determines the Quality Risk associated with each Change Control.
+ Provides QA assessment and approval decision for Change Controls.
+ Tracks and maintains Change Controls in TrackWise system.
+ Follows up on outstanding change controls that have been requested to make sure they get closed out.
+ Follows up with Change Control owners to make sure all new Change Controls are completed on time.
+ Tracks KPIs tied to Change Management and provide updates to department management monthly.
+ Responsible for monitoring projects tied to Change Controls and Training, and attending necessary meetings as required to provide QA input.
+ Assists with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
+ Performs any other assignment related to with Quality Systems responsibilities.
Requirements
+ Minimum of a bachelor’s degree in a science related field with three (3) years of Quality Assurance experience in Animal or Human Biologics or Pharmaceutical manufacturing.
+ Excellent oral and written communication skills.
+ Attention to detail imperative.
+ Organization skills along with ability to manage time and work with little supervision.
+ Ability to teach, coach or assist site regarding various systems.
+ Ability to work cross-functionally and establish effective working relationships with other departments along with working independently, interacting with all levels of management.
+ Decision Making & Delivering Results; analytical thinking.
+ Proficiency with PCs and MS Office applications (i.e., Outlook, Word, Excel) required; familiarity with electronic Training and Change Control systems.
+ Familiar with USDA 9 CFR and cGMP Regulatory requirements.
+ Knowledge of quality assurance processes/systems.
+ Knowledge of and/or experience working in a regulated environment (e.g., USDA, FDA, etc.) is a plus.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Source : Boehringer Ingelheim
