Manager, Quality Assurance, Materials Resourcing and Release (34101_Baltimore)
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, Material Resourcing and Release is responsible for the overall management of the quality aspects of the raw material sourcing, compliance, sampling and release program at the Camden Emergent BioSolutions facility and Maryland Central 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. Planning and organizing the release of materials for manufacturing and distribution will be a key deliverable for this role. To be successful in this role, the QA Manager, Material Sourcing and Release will work with cross-functional groups including Materials Management, Supply Chain, Project Management, Warehouse, Corporate Supplier Quality, Laboratory Services, Manufacturing, Packaging, and other members of site Quality Assurance.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to Ensures raw materials procurement, raw material release, SAP data maintenance, product manufacturing and safety consistent with quality, and regulatory requirements by:
• Management of the Raw Material Resourcing Program:
o Determine raw materials and API testing requirements via the Compendial, Client Specific, and Vendor Qualification.
o Creation and Maintenance of Raw Material Specifications and other Controlled Documents.
o Ensure that Emergent BioSolutions complies with the mandates of GMP requirements for incoming, in-process, and finished materials.
o Responsible review and approval of multiple master data objects in SAP including Q-Info Records, Quality Inspection Plans, Material Master Inspection Types and Bill of Materials.
o Responsible for the assessment of Supplier-Initiated Change Notices
o Responsible for working with the purchasing department and collaborating on supplier corrective actions requests as needed for non-conforming materials
o Understands the various data flags and components of SAP data and how they relate to downstream SAP processes and transactions.
o Responsible for evaluation of Raw Materials for Risk including TSE/BSE, Viral Clearance and Melamine and Nitrosamine
• Management of the Raw Material Release Program:
• Harmonization of Camden processes with the MDCW
o Prioritize the Quality Assurance Raw Material Release Team’s workload and manage deliverables to ensure appropriate coverage and timely completion of deadlines.
o Review, evaluate and approve test results to disposition raw materials for use in the manufacturing and packaging processes.
o Performs release of raw materials exercising judgment within defined procedures and regulations.
o Review and approve master printed material proofs and lot specific proofs prior to use.
• Management of the Raw Material Release Team:
o Provides leadership, mentoring, coaching and supervision
o Evaluate employees through performance reviews, ongoing coaching and feedback methods.
o Management of the Raw Material Release Training Program to ensure training effectiveness in application of job skills
• Track, trend and report metrics on a monthly basis to Senior Management
• Work productively with cross functional groups within the organization.
Quality System Support
• Provide logistical and technical knowledge support of Client or Regulatory audits on an “as needed” basis.
• Participate on response teams to address observations and recommendations made during inspections.
• Author and execute tasks for document revisions.
• Drives on-time closure of all quality events: deviations, non-conformances, CAPAs, and change controls related to Document Control quality system performance at Camden and MDCW.
• Act as subject Matter Expert (SME) for specified functions within department.
• Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product at Camden and MDCW
• Increasing knowledge between SAP platforms
• Attendance and presentation preparation for QMR
• Providing input into LIMS site integration
• Facilitate and or attend relevant tier meetings
• Coordinate and lead department 6S activities.
• Identify opportunities for improvement within scope of work.
• Educate department personnel on lean concepts.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BS degree in Chemistry/Biology or related discipline required with 6 years Quality Assurance experience, or MS degree in Chemistry/Biology or related discipline with 2-4 years Quality Assurance experience in a CGMP environment.
• Demonstrated experience leading a staff through mentoring and coaching in support of business needs, evaluating performance and proactive handling of employee relations.
• In-depth working knowledge of SAP inventory management system is required. True understanding of the use of this ERP system for materials management from sourcing to disposition is a vital aspect of this role.
• Results driven individual who seeks to optimize resources and build effectiveness through cross functional approach for training and team utilization.
• Strong proficiency in managing multiple priorities, prioritizing individual and team’s assignments, and meeting demanding timelines Excellent written and verbal skills.
• Takes initiative to identify and implement changes to ensure continued compliance with internal and external compliance.
• Ability to exercise judgment within defined practices and policies by selecting methods and techniques for obtaining solutions including strategic CAPA.
• Ability to work in a team environment as the quality representative with both internal and external customers
• Proficient knowledge of Pharmaceutical CGMP Regulations.
• Must have strong attention to detail.
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.