Analyst III, QA Compliance
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 Analyst III, Quality Systems is responsible for Quality oversight of processes in manufacturing and/or laboratories.
Support internal and external Quality Systems, such as facility/equipment, materials, production, laboratory, packaging/labeling, final drug product review, and quality. Supports internal and external customers. Assure compliance with current GMPs.
II. ESSENTIAL FUNCTIONS
• Supports the Quality Systems department in various tasks associated with eQMS processes.
• Critically review complex records (e.g., stability data, complaint investigations, CAPA Plans, deviation investigations etc.) to ensure completeness, accuracy and compliance.
• Serves in a decision-making capacity on major document changes, deviations, corrective and preventive actions, change controls and other projects.
• Exercises judgment within defined procedures to determine appropriate action for resolution of quality issues.
• Writes moderately complex technical documents.
• Assist in the maintenance of quality plans, including tracking and advancing initiatives, routinely reporting progress and maintaining documentation as it relates to Quality Systems.
• Compile and report performance metrics for Deviations and other relevant Quality Systems activities.
• Revise Standard Operating Procedures and Forms, as needed.
• Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.
• Participates in relevant lean and operational excellence activities.
• Resolves a wide range of issues in creative ways. Defines appropriate actions and requirements for resolution of issues.
• Provide logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems.
• Communicates effectively with management project status, issues and mitigations
• Maintain company quality and safety standards.
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 degree in Chemistry/Biology or related discipline with 4-6 years GMP experience required, 2-3 years Quality Assurance experience required.
• MS degree in Chemistry/Biology or related discipline with at least 2 years Quality Assurance experience may be substituted.
• Proficient knowledge of cGMP, minimum of 1 year in an FDA regulated industry.
• Ability to make sound decisions regarding compliance-related issues with moderate supervision.
• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Strong communication skills (written and verbal) and strong organizational skills.
• High level of personal/departmental accountability and responsibility.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to use computer programs such as Access, Excel, SAP and an electronic document management system.
• Ability to work in a team environment and to work within that team to maximize efficiency and throughput.
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.