Specialist, LOS Quality Systems - Boehringer Ingelheim
St. Joseph, MO
About the Job
Description
Support local quality assurance Learning Management System (LOS) and local training processes within Quality Systems. Ensure 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 Operations and Quality management, end users, Instructors, and other LMS administrators to plan, organize, manage, and support learning content and events consisting of e-learning, and instructor-led sessions, and any associated training and learning items.
Duties & Responsibilities
+ Creating learning courses, curricula, assignment profiles, manage new and existing user accounts, modify training due dates
+ Escalate and liaise with LOS technical experts to resolve and remediate LOS technical issues
+ Perform/identify GAP analysis as needed. Work within Quality Systems Team and cross-functionally to remediate and close GAP’s related to learning plans.
+ Provide technical LMS customer support to STJ AH employees through local communication
+ Ensure support of regulatory authority inspections and audits for training topics (preparation, conduct and follow up activities/reporting – as applicable)
+ Present LOS introduction material during New Employee Orientation.
+ Data entry within LOS - Offline Training Rosters, On the Job Training documentation, curriculum modification requests, etc.
+ Manage and file all controlled GMP documentation in compliance with internal procedures and policies, as well as, regulatory requirements.
+ May be responsible for the management of training activities, which includes scheduling, assignment, recording and tracking of internal and external training. Provide support for Operations and Quality colleagues and support Site Management with reporting and trending analysis.
+ Participation on a variety of committees/teams to ensure training is aligned and implemented according to recommendations and requirements.
+ Identify Quality System process initiatives for optimization and compliance. Lead and execute improvement plans within area of responsibility.
+ Monitor and maintain local site curricula to ensure compliance standards are met per leadership recommendations. Facilitate and ensure all local site Operations and Quality functional areas have curriculum built following role-based process and assigned through LOS.
+ Provide Process Improvement initiatives to site management on ways to enhance or replace existing training based on role and responsibilities,
+ Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation in the community.
Requirements
+ Associates degree from an accredited institution with two (2) years of with learning management systems within Quality Assurance/Compliance organization or relevant experience within a GMP manufacturing site or similar environment
+ In lieu of Associates degree, a minimum of five (5) years of experience with local training processes within Quality Systems or relevant experience within a GMP manufacturing site or similar environment
+ Strong computer skills to include Microsoft Office suite, LOS
+ Ability to utilize computer programs such as Microsoft Office suite, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications
+ LOS Domain Administrator system access to create courses and learning plans, assigning specific learner groups to specific learning plans, and tracking learners’ progress. Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess procedures and recommend improvements to existing quality systems
+ Ability to effectively train others on relevant learning systems
+ Ability to collaborate cross functionally
+ Strong oral and written communication skills
+ Ability to deliver timely results
+ Knowledge of LOS software and compliance regulations
+ Demonstrated written and verbal communication, organization and teamwork skills
+ Sound decision making skills along with ability to take quick actions
+ Excellent attention to detail with an ability to be self-directed while managing projects and assigned accountabilities
+ Shares technical and compliance knowledge horizontally and vertically across the site
+ High level of demonstrated technical competence, communication, integrity/ethics and analytical thinking
Eligibility Requirements:
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
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.
Support local quality assurance Learning Management System (LOS) and local training processes within Quality Systems. Ensure 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 Operations and Quality management, end users, Instructors, and other LMS administrators to plan, organize, manage, and support learning content and events consisting of e-learning, and instructor-led sessions, and any associated training and learning items.
Duties & Responsibilities
+ Creating learning courses, curricula, assignment profiles, manage new and existing user accounts, modify training due dates
+ Escalate and liaise with LOS technical experts to resolve and remediate LOS technical issues
+ Perform/identify GAP analysis as needed. Work within Quality Systems Team and cross-functionally to remediate and close GAP’s related to learning plans.
+ Provide technical LMS customer support to STJ AH employees through local communication
+ Ensure support of regulatory authority inspections and audits for training topics (preparation, conduct and follow up activities/reporting – as applicable)
+ Present LOS introduction material during New Employee Orientation.
+ Data entry within LOS - Offline Training Rosters, On the Job Training documentation, curriculum modification requests, etc.
+ Manage and file all controlled GMP documentation in compliance with internal procedures and policies, as well as, regulatory requirements.
+ May be responsible for the management of training activities, which includes scheduling, assignment, recording and tracking of internal and external training. Provide support for Operations and Quality colleagues and support Site Management with reporting and trending analysis.
+ Participation on a variety of committees/teams to ensure training is aligned and implemented according to recommendations and requirements.
+ Identify Quality System process initiatives for optimization and compliance. Lead and execute improvement plans within area of responsibility.
+ Monitor and maintain local site curricula to ensure compliance standards are met per leadership recommendations. Facilitate and ensure all local site Operations and Quality functional areas have curriculum built following role-based process and assigned through LOS.
+ Provide Process Improvement initiatives to site management on ways to enhance or replace existing training based on role and responsibilities,
+ Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation in the community.
Requirements
+ Associates degree from an accredited institution with two (2) years of with learning management systems within Quality Assurance/Compliance organization or relevant experience within a GMP manufacturing site or similar environment
+ In lieu of Associates degree, a minimum of five (5) years of experience with local training processes within Quality Systems or relevant experience within a GMP manufacturing site or similar environment
+ Strong computer skills to include Microsoft Office suite, LOS
+ Ability to utilize computer programs such as Microsoft Office suite, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications
+ LOS Domain Administrator system access to create courses and learning plans, assigning specific learner groups to specific learning plans, and tracking learners’ progress. Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess procedures and recommend improvements to existing quality systems
+ Ability to effectively train others on relevant learning systems
+ Ability to collaborate cross functionally
+ Strong oral and written communication skills
+ Ability to deliver timely results
+ Knowledge of LOS software and compliance regulations
+ Demonstrated written and verbal communication, organization and teamwork skills
+ Sound decision making skills along with ability to take quick actions
+ Excellent attention to detail with an ability to be self-directed while managing projects and assigned accountabilities
+ Shares technical and compliance knowledge horizontally and vertically across the site
+ High level of demonstrated technical competence, communication, integrity/ethics and analytical thinking
Eligibility Requirements:
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
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
