Specialist II, Quality Assurance

 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I.    JOB SUMMARY 
The Quality Engineer, Specialist II is responsible for performing technical functions in the Quality Assurance Department.  Primary functions will be client liaison, investigating non-conformances, performing risk assessments, reviewing protocols and reports, trend evaluation and reporting, technical review of critical procedures and processes, coordinate process changes and new product introduction, assist with regulatory and client responses, and develop and implement process improvements.  

 

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

•    Individual will be a direct client liaison assigned the responsibility for specific project related QA product/client relations and support.  
•    Individual will be liaison between Quality Assurance and other departments to ensure Quality Assurance commitments are completed.  They will operate in a cohesive fashion.
•    Required to work both independently and with other departmental or non-departmental personnel.
•    Investigation and writing of non-conformances such as deviations, complaints, OOS, etc
•    Reviewing process, product and equipment related validation and stability protocols and reports
•    Performing risk assessments and gap analysis
•    Trend evaluation and reporting
•    Technical review of critical SOPs and processes
•    Coordinate and work with Project Managers and Technical Transfer personnel on process changes and new product introduction
•    Review client regulatory annual product reviews
•    Represent EBSI Camden for Quality on Corporate Initiatives
•    Lead Trainer for new members of the Quality Engineering Team
•    Participates in Quality Assurance Process Improvement Teams at site and corporate level
•    Participates in client audits and regulatory inspections as needed
•    Other assigned responsibilities as established by Manager.

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
Specific:
•    BS or BA degree in Science or Engineering with 7-12 years of GMP experience.
•    Excellent writing and verbal ability. 
•    Experience with investigation and writing non-conformances (deviations, investigations, OOS, complaints, etc.) required. 
•    Ability to analyze data using statistical tools
•    Must be able to independently lead a team in root cause analysis and solutions implementation.
•    Willingness and ability to interact with all levels of personnel within the department and outside the department. A large portion of this activity will be solution-seeking efforts and root cause analysis.
•    Willingness and ability to represent Emergent BioSolutions at all management levels and with the clients.
•    Willingness to act as Camden site representative on Corporate Projects and Harmonization Initiatives
•    Knowledge of CGMP, EU Regulations, ISO, etc.

General:
•    Must have strong attention to detail.
•    Must have ability to work independently.
•    Ability to manage multiple priorities and tasks in a dynamic environment
•    Strong process reviews and auditing capabilities
•    Excellent written and verbal skills
•    Ability to exercise judgment to determine appropriate corrective actions
•    Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
•    Ability to use computer programs
•    Ability to work in a team and individual environment
•    Ability to present the outcome of investigations on non-conformances to management and/or client using visual tools such as PowerPoint and Visio.

 

IV.     PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

 

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 environmen