Manager, Quality Assurance Batch Release

Location
Baltimore (Camden), MD, US
Posted
Aug 23, 2020
Ref
656143300
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

The QA Manager, Batch Release is responsible for managing and facilitating the review and release functions of the Camden batch release process. The QA Manager, Batch Release will supervise the Batch Release team and perform Batch Release activities. Responsibilities will also include process improvements as well as providing problem solving expertise.

The QA Manager will interact with personnel throughout the organization to provide guidance necessary to maintain and improve CGMP compliance at the company.

ESSENTIAL FUNCTIONS

Management
  • Direct, develop and coach a staff of 6 to 8 individual direct report to achieve goals based on corporate and site objectives by optimizing resources and building team effectiveness
  • Prioritize the Quality Assurance Batch Release Team's workload and manage deliverables to ensure appropriate coverage and timely completion of deadlines
  • Demonstrate strong leadership skills while providing mentoring, coaching and supervision
  • Train and mentor personnel on processes to resolve open issues resulting from record reviews and deviation issues
  • Management of the Batch Release Training Program to ensure training effectiveness in application of job skills
  • Track and trend metrics for QA as needed for Senior Management

Batch Release
  • Responsible for ensuring that executed batch records are reviewed and approved within Emergent and CGMP Guidelines
  • Represents the Quality Department as the SME for the Batch Release process.
  • Perform final disposition of batch records
  • Internal partner to Project Management, Manufacturing, Packaging, and Warehouse teams to resolve issues that arise
  • Review and approval of GMP documents such as Standard Operating Procedures (SOPs)
  • Actively involved in daily operations to meet schedules and to resolve problems
  • Represents Quality Assurance to guide various project and technical meetings, as needed
  • Supports and Assists Quality Systems on timely closure of batch related Deviations, TPC's, CAPA's, and Corporate Compliance Gap Analysis

Continuous Improvement
  • Identify opportunities for improvement within the Batch Release process
  • Participate in operation excellence activities
  • Educate department personnel on lean concepts

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.

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
  • Ability to make sound decisions regarding compliance-related issues
  • Strong leadership skills; high level of personal/departmental accountability and responsibility


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.