Specialist I, Quality Trainer

Location
Rockville, MD, US
Posted
Jun 13, 2021
Ref
723544400
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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

The Specialist I, Quality Trainer is responsible for the management of the site Training Program including development, scheduling, database management and presentation of training materials as needed. Participate in Project Teams as they relate to the site. Work with other Emergent facilities to harmonize training.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Responsible for site training coordination.
  • Manages the Learning Management System (LMS) and serve as the point of contact.
  • Issues and distributes revised SOP's to the applicable departments for employee training.
  • Supports and partners with the Operations, Quality Control, Facilities and Engineering, Human Resources and other groups that require training management.
  • Supports the other departments for workflow development and training issuance.
  • Develops training plans and job aids as needed - Instructional Design.
  • Assists employees with training for further employee development.
  • Schedules training for internal and external classes.
  • Maintains a reference library for guidance documents and training materials.
  • Develops an effective GMP training classes.
  • Assists the management team with on-boarding of new employees (training for GMP, visual inspection, gowning, etc.).
  • Creates 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 standard operating procedures and established regulatory principles.
  • Ensures department personnel fully support compliance-based activities by maintaining current training requirements.
  • Participates and provide SME resources to support all FDA and non-US regulatory audits and technical discussions.
  • Interfaces with all levels of Emergent employees.
  • Other responsibilities assigned by the Director of Quality.
  • R equires vaccination against different viruses including Vaccinia virus.


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • Required: Bachelor's degree from a four-year college or university in any of the following disciplines: Biology, Chemistry, Engineering, Pharmacy, Information Technology or any related discipline
  • Prior experience with US and EU pharmaceutical regulations, and training in a Pharmaceutical environment.
  • Experience with developing training plans, agendas, training curricula, as well as application of GMP principles, and working in an FDA regulated environment highly desired.
  • 3-10 years progressive experience with planning, managing training programs, developing programs to support organizational needs and conducting GXP training programs
  • Critical analytical skills, strong verbal and communication skills highly desired.
  • 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.

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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.

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