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Analyst II, GMP Training

Emergent Biosolutions
United States, Maryland, Baltimore
January 14, 2023

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.

JOB SUMMARY




  • The Senior Training specialist position reports to Supervisor/Manager Manufacturing.
  • Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are prerequisites.
  • This role is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.



ESSENTIAL FUNCTIONS




  • The Senior Training Specialist is responsible for managing and administering the following:

    • Site Training Coordination for manufacturing personnel
    • Assist the management team with on-boarding of new employees (training for GMP, visual inspection, gowning, etc.)
    • Issue and distribute revised SOP's to the applicable departments for employee training
    • Gown train personnel, contractors, and temporary employees
    • Create one-point trainings requested by manufacturing management
    • Develop training plans and job aids as needed - Instructional Design
    • Assist employees with memberships and training programs for further employee development
    • Create power point trainings as requested by training department and manufacturing management
    • Schedule training for internal and external classes
    • Taking new hires from Tier 1 through Tier 3 trainings
    • Support the eDocs team for workflow development and training issuance
    • Supports Emergent QA during audits and regulatory inspections
    • Develop effective GMP training classes
    • Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals
    • Interfaces with all levels of Emergent employees
    • Responsible for the current SOPs as they pertain to writing, revision, implementation and training
    • Responsible for ensuring that documentation utilized in the manufacturing process is reviewed according to operating procedures and established regulatory principles
    • Other assigned responsibilities as established by Training Manager




Compliance:




  • 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



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.

EDUCATION, EXPERIENCE & SKILLS




  • HS diplomawith 5 or more years' experience with production processes under GMP compliance OR
  • Associate degree in a Scientific, Engineering or Biotech field with 2-4 years' experience with or biologic production processes under GMP compliance OR
  • Bachelor's degree in a Scientific, Engineering or Biotech field with 1-2 years' experience with biologic production processes under GMP compliance
  • Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
  • Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary



Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 .

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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