Specialist II, Quality Assurance (33858_San_Diego)
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.
The Specialist II is a member of the EBS Global Clinical and Development Quality Team and reports to the Sr. Director Clinical and Development Quality.
The Specialist II is a lead for the phase appropriate effort for R&D and is responsible for execution of the strategic plan aligned with the Corporate QMS transformation effort and aligned with R&D goals (multi-year efforts). The focus of this role is in managing this project and driving the cross-functional R&D and Quality teams to ensure Phase appropriate GXP compliance and successful execution of Quality Plan activities, within Project timelines.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Provides support to Clinical and Development Quality Organization Implementing and harmonizing Quality Management Systems for Development and early phase Clinical and Non-clinical Manufacturing, at the EPDG and San Diego sites, as per EBS Global Quality Management System Requirements.
- Responsible for periodic updates to the program and non-program related budgets and resource models for Clinical Quality, San Diego and Gaithersburg 300P sites. This role organizes annual budget planning for these teams and ensures regular budget reviews and updates occur as needed to ensure visibility to budget adherence and resource needs.
- Supports Client Audits and manages CAPA activities for continuous improvement as needed.
- Supports IND/BLA submissions by reviewing CMC data and the source documents.
- Phase Appropriate Effort/QMS Transformation:
- Executes strategic plan for phase appropriate effort and manages/coordinates input to QMS transformation effort for R & D/Clinical and Development Quality
- Networks with key contacts outside own area of expertise. Applies a broad scope of knowledge across or within technology platforms; assist with modeling or design; assist with complex troubleshooting.
- Serves as a change agent for continuous improvement. Creates formal networks involving coordination among groups and other sites.
- Quality Systems:
- Lead or participate in cross-functional teams to address quality system issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact
- Serve as SME to global teams to identify and implement improvements to quality processes as needed and assigned.
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
- The candidate will have a bachelor’s degree (Preferably masters) in Biology/Molecular biology/Biotechnology or related field with at least 8 years of experience in biotech/biopharmaceutical industry.
- At least 5 years’ experience in GXP compliance management and/or quality systems improvement/implementation. Experience in R & D environments outside of Clinical or Development Quality a plus.
- The candidate must be knowledgeable with US GMP regulations (21CFR210, 211).
- The candidate must also have demonstrated compliance experience with Good Laboratory Practices for Non-Clinical Laboratory Studies (21CFR58).
- Must have experience and an in-depth understanding of GXP and Quality Systems in Development and Clinical Manufacturing Environment, in addition to strong technical, communication (oral, written, listening), and computer (MS Excel, graphics/statistical software) skills.
- The candidate must have a keen attention to detail, an excellent organizational ability that includes multi-tasking and shifting of priorities as needed, and an ability to work well in a fast-paced, team-oriented environment.
- The candidate must have knowledge of Drug Development Process, ability to understand Biological Processes, Phase specific GXP compliance, and Data Governance Process.
- Good Communication, Interpersonal, Organization, & Planning skills are required.
- The candidate must be able to work on highly complex and unique challenges in R & D environment where analysis of situations or data requires an evaluation of intangibles and to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results. Determine methods and procedures on new or special assignments.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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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.