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Job Details


Emergent Biosolutions

QA Manager, Quality On the Floor (34124_Baltimore)

Pharmaceuticals

All

Yearly

No

Baltimore, Maryland, United States


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 Manager, Quality On the Floor is responsible for assuring the quality of products packaged and stored at the Emergent BioSolutions Baltimore Facility and WDCW warehouse. The QA Manager, Quality on the Floor will supervise the QA On the Floor teams from all shifts and all areas, including QA for Packaging and Warehouse. Solid working knowledge of the current site ERP system, SAP, including the ability to train others on relevant functionality will be a key responsibility for this role. The QA on the Floor Department provides expertise in problem solving and process improvements. To be successful in this role, the QA Manager, Quality On the Floor will work with cross-functional groups including Materials Management, Supply Chain, Project Management, Warehouse, Facilities, Corporate Supplier Quality, Laboratory Services, Manufacturing, Packaging, Safety and other members of site Quality Assurance to provide guidance 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.
• Supervision of a staff of 10 to 20 individuals who work across multiple shifts.
• Prioritize the Quality on the Floor Team’s workload and manage deliverables to ensure appropriate coverage and timely completion of deadlines.
• Solve problems independently and within a team environment.
• Develop and coach direct reports to achieve goals based on corporate and site objectives by optimizing resources and building team effectiveness.
• Evaluate employees through performance reviews, ongoing coaching and feedback methods.
• QA oversight at the source utilizing on the floor real time packaging batch record and warehouse documentation review, disposition, in-process auditing and manage resolution of in-process deviations.
• QA oversight of packaging and warehouse processes. Provides quality guidance to packaging and warehouse personnel to manage resolution of in-process deviations.
• Perform walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.
• Review and approval of GMP documents such as SOPs, Master Batch Records, finished product batch records, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.
• Write, review, and assesses deviations; includes performing risk assessments, participating in and leading root cause analysis investigations, tracking and follow-up plans.
• Train and mentor personnel on processes to resolve open issues resulting from record reviews, on the floor walk through activities, deviation and CAPA issues.
• Implement solutions for identified issues affecting daily packaging and warehouse operations.
• Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics monthly for Senior Management.
• Represents Quality Assurance 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.
• Supports and assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.
This will be a day shift Monday thru Friday 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 6-12 years of QA experience with at least 3 years in a GMP environment or FDA regulated industry. Minimum of 2-3 years of Supervisor/Manager experience required.
• 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 use computer programs such as an electronic Document Management System 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.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.

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.

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 [Register to View] .

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.