Specialist I, Deviation Approver
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
The Specialist I QA Deviation Approval is responsible for support of the QA Operations Deviation Approval group to ensure compliance and closure of all Emergent deviations. The Specialist I, is responsible for review and approval of deviations and working with departments to support investigations and root cause analysis. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance including, but not limited to, manufacturing records and Quality Control laboratory data for batch and material releases, specifications, SOPs, validation protocols and summary reports, master plans, deviation investigations, CAPAs, and change controls
• With minimal supervision, resolves a wide range of issues in creative ways. Defines appropriate actions Demonstrate good judgement in selecting method and techniques for obtaining solutions
• Network with senior internal and external personnel in own area of expertise
• Communicates effectively with management project status, issues, and mitigations
• Assumes responsibilities for assigned tasks including a subset of the activities listed herein
• Represent QA Operations Deviation Approval team and process during regulatory agency and ISO inspections.
• Represent QA Operations Deviation Approval team and process for customer relation activities.
• Ensure compliance with the cGMPs regulations and current procedures
• Lead cross-functional teams to address facility 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 to product
• Write, review and revise standard operating procedures as needed.
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
• B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 7 years of relevant experience.
• Experience must include 4-6 years of prior experience with deviations and investigations in a GMP Quality organization.
• Must have sound knowledge of the functions and expectations of and proficiency in Good Manufacturing Practices in an FDA regulated manufacturing facility. Preferably possess skills and general knowledge of large molecule/vaccine manufacturing processes.
• Previous electronic quality system experience is desired.
• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
• Must be highly organized, detail oriented and able to manage multiple projects.
• Solid communication and presentation skills required.
• Must understand cGMPs, CFR, USP, and Aseptic Processing Guidelines
• Must have prior experience with regulatory (FDA/USDA) inspections
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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.