Specialist I, Materials and Supplier Quality (LTH)
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.
Provide Quality oversight and approval for all material creation and changes, as well as supplier change notifications by evaluating their impact to products/materials. Serve as site point of contact for all supplier management activities, including writing and managing quality agreements, risk assessments, deviations and coordinating with Global Supplier Quality Management team.
Act as Quality change control reviewer and support management of the change control system. Provide quality guidance and participate in Compliance or continuous improvement projects. Represent Emergent in regulatory communications including audits, submissions and other communications or meetings.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Materials / SAP Quality SME:
• Represent site Quality by providing quality oversight of all material creation and change requests
• Participate in Global Initiatives to maintain critical material meta data in SAP
• Participate with Global teams to ensure alignment between site and global processes
• Develop and deliver training to site personnel for Material, Supplier-related processes as needed
• Attend routine global meetings and implement changes as needed
Supplier Quality Management:
• Represent Site quality for supplier quality-related activities
• Write/Revise Quality Agreements
• Create and/or assess Supplier Corrective Actions (SCAR)
• Create or approve Risk Assessments for material and supplier usage
• Function as owner of Supplier Change Notification Process
• Approve supplier change notifications and/or change controls as QA representative
• Provide Quality oversight of projects including: Equipment Qualification, Method Validation, Aseptic process validation, Process Validation, Work Order Review, Cleaning and Sterilization Validation, Shipping Validation, Regulatory Submissions, and Contract Manufacturing.
• QA Representative for the Change Control System; reviewing and approving change requests, monitoring the timely completion of change activities, and performing final change approvals.
• Serve as reviewer and approver of documents such as qualification reports, change controls, validation & technical study protocols and other cGMP compliance documentation; ensuring data integrity and traceability, clarity of technical writing, compliance with SOP’s/regulations and suitability for review by regulatory authorities
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the site.
• Provide quality guidance to continuous improvement projects, product development, validation and transfer initiatives.
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
• Bachelor’s Degree in Biological Science or similar scientific field
• Minimum of 8 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities
• Must have a full understanding and knowledge of CGMPs, Health Canada and EU Regulations.
• Must have Change Control, SOP, investigation writing skills and demonstrated ability to critically evaluate content and criticality of information.
• Must be able to critically evaluate material/supplier changes for impact to Quality.
• Proficiency in SAP, MS Office products and spreadsheet skills are required
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.
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.