Specialist I, Quality Assurance

Location: 

Dublin, IE


 

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.

Reporting to the Manager, Quality Assurance, this is an advanced position requiring significant expertise/specialization in area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).

 

The role is responsible for 1) quality support of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements 2) executing Quality requirements in support of commercial and developmental programs 3) ensuring the realization of industry best practices for GxP and 4) serving as quality approval proxy as required. 

The Senior Quality Specialist will be capable of working on complex issues where analysis requires an in-depth assessment, considering many variables and potential consequences. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to Emergent products. May assist with compliance audits as required. 

 

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

  • Responsible for Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination product(s) (devices) at Emergent.
  • Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews to ensure completeness, accuracy and compliance.
  • Co-ordinate with CMO Quality and Operations teams to independently resolve discrepancies while liaising with internal Quality Groups to ensure on-time disposition of Finished Product. 
  • Evaluation and approval of supplier and CMO change notifications. Author and coordinate applicable changes through the Emergent Change Management process as required.  
  • Author, review and approve Quality Related Procedures as required in accordance with Emergent internal procedures and GMP principles to ensure quality objectives are met.
  • Active participation and support implementation of continuous improvement initiatives of the Quality Business Unit.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions. 
  • Support the stability program for combination products (devices) as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
  • Support the Vendor and Raw Material Qualification Program through collaboration with SQM Group to facilitate discussions between Emergent and CMO Quality organizations to establish responsibilities for Quality related functions.
  • Provide Quality support for technology transfer across contract organizations to include; validation/verification activities and Laboratory Investigation Report review and approval for commercial and developing product pipelines.
  • Support regulatory department with any regulatory filings associated with new market authorizations, annual reports and change supplements.
  • Responsible for identifying defects and have the authority to report device / combination product defects at any time.

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 management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Academic degree in Engineering or Science (preferably in an Applied Science). 
  • 5 + years’ experience working in international device and pharmaceutical /bio pharmaceutical companies with increased level of responsibility.
  • Comprehensive knowledge of cGMP, Manufacturing and Quality Assurance experience. 
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrates thorough knowledge of FDA / EMEA standards and quality systems. Having interface with or participating in regulatory agency inspections preferred.
  • Ability to deliver in a challenging environment using own initiative with little instruction on routine work, general instructions on new assignments.
  • Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.


Hybrid Working Model
A flexible working model is offered, where employees work partly in the physical workplace, and partly from home or another workspace.  

Travel:
Approximately 15% domestic and international travel (passport required).

 

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.