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Analyst II, Quality Assurance
4 months ago
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
The Analyst II on the Floor is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Baltimore Facility. The Analyst II will perform Quality on the Floor functions. Our QA Department provides expertise in problem-solving and process improvements. The QA Specialist will interact with manufacturing personnel and Quality Engineers to provide guidance necessary to maintain and improve CGMP compliance at the company.
I. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern.
• Review logbooks, reports, data integrity, and GMP records
• Quality at the source utilizing on the floor real time batch record review, disposition and in process auditing.
• QA oversight of manufacturing processes. Provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
• Actively involved in daily operations to meet schedules and to resolve problems.
• Revise standard operating procedures (SOPs)
• Assist with deviations and area investigations.
This will be third shift (22:00 pm to 06:30am) Sunday thru Thursday position. Overtime and weekend work may be required based on business needs.
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 management’s 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 in Science or Engineering with 0-2 years of GMP experience; QA/QC role preferred
• Ability to make sound compliance-related decisions with minimal supervision
• Must possess strong attention to detail.
• Ability to navigate lab equipment software and computer programs such as Veeva (Document Management System) and SAP (ERP System).
• Proficient knowledge of CGMP.
• Strong communication (written and verbal) and organizational skills.
• Ability to independently manage multiple priorities in a dynamic environment.
• High level of personal/departmental accountability and responsibility.
• Excellent problem-solving and teamwork skills.
• Proficient at resolving issues in creative and innovative ways.
• Exercises good judgment in selecting methods/techniques to achieve positive results.
• Understand and respond appropriately to a diverse population.
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
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.
