Specialist I, Quality Assurance On The Floor, 3rd Shift
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I. JOB SUMMARY
The Specialist I for QA on the Floor is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Baltimore Facility. The QA Specialist I 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.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Key Duties will include:
• Quality-at-the-source utilizing on the floor real-time batch record review, disposition, and in-process auditing.
• 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.
• Delivers QA oversight of manufacturing processes.
• Provides quality guidance to Manufacturing personnel to manage resolution of in-process deviations.
• Writes and revises Standard Operating Procedures (SOPs).
• Reviews and approves CGMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.
• Makes recommendation to QA Management for the release of product based on QA record review and approval.
• Actively involved in daily operations to meet schedules and resolve problems.
• Demonstrate strong organizational skills related to priorities and workload.
• Ability to solve problems independently and within a team environment.
• Train and mentor Production personnel on manufacturing processes to resolve open issues resulting from record reviews, on the floor walkthroughs, and deviation issues.
• Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
• Implementation of solutions for identified issues affecting daily manufacturing operations.
• Represents QA to guide various project and technical meetings, as needed.
• Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.
• Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs) on eDocs.
• Review of product master recipes and batch process orders in SAP.
• Supports and assists Quality Systems on timely closure of CAPAs, Gap Analysis and Product Complaints.
• Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics on a monthly basis for Senior Management.
• Participation in biomedical screening is required.
This will be a 3rd shift (10:00 p.m. to 6:30 a.m.) Monday thru Friday position. Overtime and weekend work required as needed based on manufacturing 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 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 in Science or Engineering with 5-10 years of GMP experience.
• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ability to use computer programs such as eDocs and SAP.
• Ability to work in a team environment.
• Proficient knowledge of CGMP.
• Coordinate multiple tasks simultaneously.
• Understand and respond to a diverse population.
• Gowning certification required.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Minimum of one year in a FDA regulated industry.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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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.