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, Device Quality, this position is responsible for day to day implementation of Quality Systems and infrastructure appropriate for commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements. Individual executes Quality requirements for the oversight of contract manufacturer of medical devices, associated testing, and supply of medical device products ensuring the realization of industry best practices for GxP.
The Quality Specialist will review and prepare for approval batch records, Deviations, CAPAs, Change Controls, Supplier Notifications. Individual will also serve as quality approval proxy as needed, and support supplier audit activities with approximately 15% domestic and international travel (passport required).
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Review and prepare for approval CMO executed manufacturing records for formulation, filling, assembly, and labeling, packaging and shipping operations of products to ensure completeness, accuracy and compliance.
• Review and prepare for approval of CMO production and testing procedures, batch records, specifications and validation protocols and reports.
• Review and prepare for approval CMO related production deviations, conducting assessment of batch impact and final decision recommendations for batch disposition. Coordinate and lead cross functional teams to perform high level non-conformance investigations, including root cause analysis. Review and approval of CMO related OOS investigations. Authorize resampling, retesting and determination of batch impact.
• Independently resolve discrepancies found during review with CMO Quality team.
• Review and approve supplier and CMO change notifications. Author and coordinate applicable changes through the Emergent Change Management process as required.
• Review various types of documentation to ensure completeness, accuracy, and compliance. This includes SOP revisions, Protocols, Data Sets, Material Specifications, Validation reports.
• Contribute to the continuous improvement of Quality review/ release processes.
• Support the stability program for medical devices as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator.
• Collaborate to support approval of Quality Technical agreements for contract manufacturing, testing, holding/ distribution facilities and raw material suppliers. Facilitate discussions between Emergent and CMO Quality organizations to establish responsibilities for Quality related functions
• Serve as Quality Approval Proxy for all areas noted above as required (i.e. Deviation, CAPA, Batch Record documentation, Batch Release, etc.).
• Assist audit group with scheduling, preparation, and completion of audits for contracted services and material suppliers.
• Review and approve technology transfer activities across contract organizations for production and testing. This includes review of CMO validation protocols and reports for equipment, process and test method enhancements
• Support regulatory department with any regulatory filings associated with new market authorizations, annual reports and change supplements
• Work with translation service providers to conduct translation activities for manufacturing, testing, qualification/ validation activities.
• Responsible for identifying defects and have the authority to report device 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 managements 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
• BA/BS (preferably in an Applied Science) or equivalent work experience.
• Minimum 6 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Medical Device Manufacturing and previous Quality Assurance experience.
• Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred.
• Candidate must exhibit strong interpersonal and communication skills.
• Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
• Strong oral and written communication skills.
• Ability to work independently and in a team setting with minimal supervision
• Ability to make sound decisions regarding compliance-related issues with minimal supervision.
• Strong Leadership, high level of personal/departmental accountability and responsibility.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics:
☒ Ability to organize/coordinate ☒ Comprehend and follow instructions
☐ Direct, control and plan ☐ Independently make quick decisions to solve complex issues
☒ Problem Solve ☒ Analyze/Interpret data and information
☒ Perform with frequent interruptions ☒ Make decisions using sound judgment
☐ Supervise/Manage others
☒ Good eye/hand coordination ☐ Visual Acuity
☒ Use keyboard/computer/phone ☐ Detect/Distinguish smell
☒ Detect/Distinguish hearing ☐ Maintain stationary position
☒ Position self to move ☐ Move/Traverse
☐ Ascend/Descend (climb) ☒ Reaching
☐ Calibrate precise measurements ☐ Ability to safely operate hand tools
☒ Move/Transport 50 lbs. ☒ Repetitive movement activities
☒ Regular and predictable attendance
☐ Work around extreme temperatures - cold or hot
☒ Work around noise above conversation level
☒ Work in restricted access to laboratory area
☒ Exposure to dust/gas/fumes/steam/chemicals
☒ Work with Select Agents as defined by the CDC
☐ Work irregular hours that often include nights and weekends
☒ Work in multiple locations
15% domestic and international travel (passport required)
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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.