Specialist I, Quality Systems

Location: 

San Diego, CA, US, 92121


 

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.

Specialist I, Quality Systems is responsible for the management of the site Training Program including development, scheduling, database management and presentation of training materials as outlined in the Global and Site-specific training SOP and Standards. Participate in Project Teams as they relate to the site including maintenance and periodic updates of the Learning Management System (LMS).  Work with other Emergent facilities to harmonize training serving as the Quality Assurance Trainer for San Diego site, as applicable  

Provide oversight and support of quality systems using company procedures and regulations. Conduct system and process training. Analyze business processes and recommend best practices. Provide support during internal audits and regulatory inspections.


ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Training Support:
•    Site Training Coordination for all GxP systems
•    Manage the Learning Management System (LMS), site administrator and site point of contact.
•    Distribute revised SOPs to the applicable departments for employee training.
•    Support and partner with the internal departments in San Diego and Redwood City that require training management.
•    Support the eDocs team 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 GMP, GLP and GCP training classes, as applicable
•    Assist the management team with on-boarding of new employees

Quality System Support
•    Serve as the Quality Assurance role for supported quality systems
•    Represent the Quality Systems department in a review and decision-making capacity on site projects
o    Monitor performance metrics, including identification of trends that require preventive action and cross-functional collaboration to determine the root cause of process performance issues, and taking the necessary action to improve performance
o    Present objective data regarding process performance to Functional Area and Senior Management
•    Process access requests, perform user analysis, and make recommendations for relevant computer systems for supported quality systems
•    Develop, schedule, and conduct site training for supported quality systems, assess effectiveness of training following completion
•    Coordinate work across systems, functions, and sites to harmonize workflow, clearly identify responsibilities, and optimise cross-functional team member participation
•    Perform gap analyses to identify training needs and work cross-functionally to reduce deviating events attributable to human error for supported quality systems
•    Create monthly Quality Management Review metrics for all Quality Systems

Document Control Support:
•    Responsible for approving Quality documents- SOP, Work Instructions, as assigned. 
•    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 Site Quality Head.

Compliance:
•    Comply with all Federal, State and Local regulations
•    Comply with all FDA, GxP, CDC, ICH, EHS, OSHA and EPA regulations
•    Comply with Code of Conduct, Employee Handbook, Compendia, 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 and other duties as assigned. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Bachelor’s in science or related degree, or minimum of 5 years’ experience planning, managing training programs, developing programs to support organizational needs and conducting GXP training programs
•    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
•    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

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: San Diego