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
This position 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.
Individual will be a direct client liaison assigned the responsibility for specific project related QA product/client relations and support. Note: As we are a contract manufacturing organization some clients are in different time zones and may require occasional work hours that are not within the standard workday.
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, OOT, 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
Developing and implementing process improvements
Participates in Quality Assurance Process Improvement Teams
Participates in client audits and regulatory inspections as needed
Other assigned responsibilities as established by Manager.
No direct reports, but routinely may provide guidance to other departmental personnel.
Routinely represents QA management in direct discussions with clients.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
BS or BA degree in Science or Engineering with 5+ 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.
Knowledge of CGMP, EU Regulations, ISO, etc.
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 Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25 lbs, and pull 25 lbs. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate orally and in writing.