Analyst III, Quality Assurance (34125_Baltimore)
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 QA Analyst III on the Floor (QA III OTF) position for manufacturing is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Camden Facility. The QA III OTF will perform Quality on the Floor functions including GMP guidance during daily production operations and walkthroughs to ensure compliance. The QA Analyst III will interact with manufacturing personnel, the Quality Engineers and Quality Management to provide guidance necessary to maintain and improve cGMP compliance at the company as well as client satisfaction.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Manage multiple functional groups within Quality Operations and establish a cohesive unit that exercises Quality oversite in partnership with the operations team.
• Quality at the source utilizing on the floor real time critical data review and auditing to prevent issues from arising.
• Provides real time QA oversight of manufacturing processes including areas of equipment preparation, formulation and filling.
• Critically reviews manufacturing relevant executed batch records, log books and other GMP relevant data.
• Conduct GMP area in-process audits and walkthroughs and reviews associated GMP documentation.
• Attend daily tier meetings.
• Partner with Operations to meet schedules and resolve problems.
• Initiate deviations and assist Quality Engineers with relevant investigations.
• Coach and mentor new QA OTF personnel.
• Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.
• Write and revise Standard Operating Procedures (SOPs), as needed.
• Maintain company quality and safety standards.
• Deliver a structured approach to oversight the aseptic operations for all filling lines including cleaning processes.
• Be present in the fill rooms to perform real time feedback, correction, and review of aseptic operations
• Document the oversight results as required by current standard operating procedures and corresponding GMP forms.
• Report results of the aseptic operations oversight on a frequent basis for the Senior Management of the areas involved.
• Coach and mentor personnel working the aseptic core including but not limited to Operations, Microbiology and Engineering personnel to foster a climate of routine inspection readiness.
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
BS or BA degree with 3-5 years of GMP experience required, QA/QC experience or other directly relevant experience preferred.
• Proficient knowledge of cGMP, minimum of one year in a FDA regulated industry preferred.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Must possess strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong communication skills (written and verbal) and strong organizational skills.
• High level of personal/departmental accountability and responsibility.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to use computer programs such as an electronic document management system and SAP.
• Coordinate multiple tasks simultaneously.
• Ability to work in a team environment and to work within that team to maximize efficiency and throughput.
• Understand and respond appropriately to a diverse population.
• Mandatory gowning certification required.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
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.