Specialist I, QA Batch Record Review
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 Specialist I, Batch Release is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the CGMP operation of Emergent BioSolutions in Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements. The QA Specialist I will interact with all departments 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.
Batch Review and Release
• Coordinate batch record review and approval process.
• Critically reviews GMP documents such as:
o Executed batch records for a variety of different functional areas
o Analytical Testing Data
o Microbial and Environmental Monitoring Data
o WFI testing data
o Equipment Data
• Performs SAP transactions which may include QA disposition of Intermediate Clinical and Commercial product for further manufacturing.
• Work on issues where analysis of situations or data requires an evaluation of multiple inputs.
• Resolve complex issues in creative and effective ways using a wide range of experience, professional concept and company objectives.
• Frequently interact with direct manager, subordinates, internal customers and other cross functional peers to gain alignment on sound quality decisions.
• Initiate non-conformance investigations
• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• Act in a trainer capacity for Batch Review activities for New Employees
• Review and Revise SOPs and Relevant Documents using Electronic DMS
Quality Operations Support:
• Compile and communicate performance metrics and data trend analyses to senior management for Batch Review and Release relevant activities.
• Identify opportunities for improvement within scope of work.
• Serves as change agent for continuous improvement in operational excellence activities.
• Provide logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems.
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 with at least one year in an FDA regulated industry.
• 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 an electronic document management system and SAP.
• Ability to make sound decisions regarding compliance-related issues with limited supervision.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Ability to work in a team environment.
• Working knowledge of CGMP.
IV. 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 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.
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.