Shire Training Administrator (Learning Management System) in Thousand Oaks, California

Responsible for maintaining, auditing, and administration of the locally used Learning Management System (LMS - currently Saba) supporting the Thousand Oaks facility. Serves as the Local Divisional Saba Administrator (LDSA) and subject matter expert (SME) for the LMS system. Provide guidance and direction to system users. Responsible for developing, conducting, coordinating, and promoting a variety of training and communication programs designed to satisfy system operation and training needs of the Thousand Oaks facility in compliance with facility, business network, corporate and regulatory requirements.

Essential Duties and Responsibilities

  • Serve as the Local Divisional System Administrator (LDSA) for the Thousand Oaks facility.

  • Serve as system administrator for current LMS (currently Saba) on a daily basis.

  • Data entry and processing of training activity within LMS. Maintain data integrity.

  • Coach, train, advise and develop other LMS coordinators.

  • Attend and/or conduct cross-functional and inter-facility meetings to ensure consistency in use of the LMS system and compliance to training system requirements.

  • Conduct training for on-the-job (OJT) training and Instructor Led Training (ILT) certification and perform assessments.

  • Represent Quality Systems and/or Thousand Oaks on training system matters, teams, councils, and committees.

  • Schedule and maintains training programs and courses.

  • Provide advice and partner with customers to create, maintain, and assign relevant role related training plans.

  • Benchmark best practices across business network and corporation.

  • Maintain and update departmental business indicators. Prepare metrics for the Quarterly Management Review. Identify trends, develop, and implement corrective actions.

  • Data mine, compile, and analyze training data. Create new databases and queries as required. Generate and deliver meaningful, actionable training reports.

  • Maintain paper and electronic files associated with LMS and training. Archive records as needed per respective corporate SOPs.

  • Participate in internal or external assessments as required (e.g. audits). Support process with timely closure of audit observations and audit items. Prepare training related records during regulatory agency inspections and audits.

  • Serve as the SME for audit-related deviations, investigations, and during identification of CAPA actions.

  • Assess impact of new regulations on current practices, initiate/approve document change proposals, and assist with training and auditing as appropriate

  • Attending Monthly Subject Matter Experts (SME) calls as assigned. Completing and responding to action items as assigned from the meeting.

  • May perform other duties as assigned

Qualifications:

Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience, and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

  • Must be able to read, write, and converse in English.

  • Experience working in a training environment and with LMS.

  • Advanced computer skills to include working knowledge of MS Office software (Word, Visio, Excel, PowerPoint).

  • Must be detailed oriented (e.g. accurately enter data), have the ability to meet deadlines, and handle sensitive/confidential information on a regular basis.

  • Solid analytical skills and sound judgment.

  • Working knowledge of problem solving tools (Lean and Six Sigma)

  • Project management skills; be able to effectively lead teams.

  • Strong written and verbal communication skills. Able to present business indicators to Senior Management and outside regulators/auditors.

  • Knowledge of cGMP manufacturing.

  • Must be able to read and follow detailed written instructions.

  • Must be able to navigate, conduct searches, and complete online forms on personal computer for the purposes of training, performance management, and self-service applications. Must have the ability to navigate electronic mail systems and intranet for communication purposes

  • Able to interface/interact with other departments.

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

  • Must have passion to innovate and drive for solutions.

  • Must display personal accountability for results and integrity

  • Must display eagerness to learn and continuously improve.

  • Must have uncompromising dedication to quality.

  • Must have relentless focus on rapid and disciplined action.

  • Must have respect for individuals and the diverse contributions of all.

  • Must be able to multi-task and adapt well to change.

  • Must be able to work independently to meet departmental/facility goals.

Education and/or experience:

  • Minimum of 2 years of experience as a Saba Training Coordinator (or equivalent Learning Management System (LMS)).

  • Experience in GMP related environment preferred.

  • Bachelor’s degree preferred.

Physical Demands :

The overall physical exertion of this position is sedentary work. Although a sedentary job is defined as one that involves sitting, a certain amount of walking and standing is often necessary in carrying out job duties. Jobs are sedentary if walking and standing are required occasionally and other sedentary criteria are met.

  • May be required to lift up to 25 pounds at a time and occasionally lifting or carrying articles like files or banker box of documents.

  • May be required to stand and walk frequently to access other areas in the facility

  • May be required to climb stairs rarely. Elevator access provided to 2nd floor work area

  • May be required to carry occasionally when filing or taking documents/supplies/laptop to other areas of the facility

  • May be required movement of head/neck frequently when communicating with co-workers/customers, answering the phone, and filing

  • May be required to use repetitive motion frequently of hand, finger, and wrists for the purpose of typing, data entry, and manipulating computer mouse

  • May be required to grip and grasp frequently when using a computer mouse

  • May be required to drive rarely for trainings and meetings

  • May be required to use hearing frequently when communicating with personnel in person or on the phone

  • May be required to stand occasionally when gowned in controlled manufacturing areas.

Working Environment:

  • Normal office environment

  • Inside working conditions

  • Work at computer monitor for the majority of the day

  • Overtime may be required at times

  • May be required to work or be assigned to a different shift as needed

  • Must be able to work more than 8 hours a day or 40 hours a workweek as required

  • May be required to travel for business reasons (e.g. training and meetings)

  • Will have interaction with other people

  • Pace may be fast and job completion demands may be high

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.