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 Analyst III, QA Deviations is responsible for support of the QA Operations Deviation Approval group to ensure compliance and closure of all Emergent deviations. The Analyst III will review and approve deviations and work with departments to support investigations and root cause analysis.
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 oversite of management resolves a wide range of issues in creative ways. Defines appropriate actions demonstrating good judgement in selecting method and techniques for obtaining solutions
Network with senior internal and external personnel in own area of expertise
Communicate effectively with management project status, issues, and mitigations
Assume responsibilities for assigned tasks including a subset of the activities listed herein
Support regulatory agency and ISO inspections as required
Support customer relations activities as required
Ensure compliance with the cGMPs regulations and current procedures
Participate in 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 managements assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
B.S. degree in microbiology, Biochemistry, or closely related scientific discipline with at least 5 years of relevant experience.
Experience must include 2-3 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.ABOUT EMERGENT
Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES
- Stand shoulder to shoulder no matter what
- We combine our best thinking and communicate openly to support each other.
- Break through thinking
- We take smart risks, pursue innovation and challenge ourselves to constantly improve.
- Own it always
- Every person at Emergent is engaged and accountable for delivering on our commitments.
- Compete where it counts
- We set the right goals and respect each other as we conquer them together.