Specialist I, Quality Trainer
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I: JOB SUMMARY
Accountable for the management of the site Training Program including development, scheduling, database management and presentation of training materials as needed. The primary deliverables of this position are to ensure GXP compliance, minimal employee downtime, and to support the business in the coordination of training needs through a positive customer experience. Work with other Emergent facilities to harmonize training.
II: ESSENTIAL FUNCTIONS
The Training Coordinator is responsible for managing and administering the following:
• Site Training Coordination.
• Manage the Learning Management System (LMS), site point of contact.
• Support and partner with the departments that require training management (i.e., EH&S, Human Resources, Operational Excellence).
• Support Document Control for workflow development and training issuance.
• Develop training plans and job aids as needed – Instructional Design
• Assist employees with memberships and training programs for further employee development.
• Schedule training for internal and external classes.
• Maintain a reference library for guidance documents and training materials.
• Develop effective GXP training classes.
• Assist the management team with on-boarding of new employees (training for GMP, visual inspection, gowning, etc.).
• Creating monthly Quality Management Review metrics for training.
• Responsible for creating and approving Quality documents- SOP, Work Instructions, Policy as assigned.
• Responsible for ensuring that documentation utilized in the manufacturing process is reviewed according to operating procedures and established regulatory principles.
• Responsible for the current SOPs as they pertain to writing, revision, implementation and training.
• Interfaces with all levels of Emergent employees.
• Other assigned responsibilities as established by manager.
• Comply with all Federal, State and Local regulations
• Comply with all FDA standards and SOX regulations
• Comply with all GxP, CDC, ICH, EHS, OSHA and EPA regulations
• Comply with Code of Conduct, Employee Handbook, Corpedia, E-time guidelines
• Ensure department personnel fully support compliance-based activities by maintaining current training requirements.
• Participate in and provide SME resources to support all FDA and non-US regulatory audits and technical discussions
III: MINIMUM EDUCATION, EXPERIENCE,SKILLS
• Bachelors Science or related degree
• Must have experience in Instructional Design.
• Prior experience with US and EU pharmaceutical regulations, and training in a Pharmaceutical environment
• Development of training plans, agendas, training curricula, as well as, application of GMP principles, and working in an FDA regulated environment
• 3-10 years progressive experience planning, managing training programs, developing programs to support organizational needs and conducting GXP training programs
• Critical analytical skills, strong verbal and communication skills
• Ability to work under pressure and analyze processes within scheduled timeframes
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Visio, SAP, and LMS.
• Excellent presentation skills, including written and verbal communication.
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.