Manager, Quality Assurance (Production)

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.

I.    JOB SUMMARY 
The QA Manager, On the Floor is responsible for assuring the quality of products manufactured at the Emergent BioSolutions Camden facility.  This role will supervise the QA On the Floor teams from all shifts and all areas including QA for Production, QC and Packaging.  Our QA Department provides expertise in problem solving and process improvements.  The QA Manager will interact with teams throughout the organization 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.

•    Supervision of a staff of 6 to 8 individuals who work across multiple shifts. 
•    Demonstrate strong leadership skills. 
•    Develop and coach direct reports to achieve goals based on corporate and site objectives by optimizing resources and building team effectiveness. 
•    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 the documentation, follow up and escalation of observations and areas of concern.
•    QA oversight of manufacturing processes. Provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
•    Write and revise Standard Operating Procedures (SOPs). 
•    Review and approval of GMP documents such as batch records, logbooks, and reports to ensure compliance with specifications, regulations and procedures. 
•    Actively involved in daily operations to meet schedules and to resolve problems. 
•    Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.
•    Train and mentor team members on processes to resolve open issues resulting from record reviews, on the floor walk through activities, and deviation issues.
•    Writes, 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 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.
•    Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs).
•    Supports and Assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.
•    Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics monthly for Senior Management.

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 field
•    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
 

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.