Analyst III, Quality Assurance Shop Floor
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, Shop Floor is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, investigations, and corrective and preventative actions.The incumbent will interact with external CMO clients, senior leadership, direct manager, peers, internal customers, and other cross functional peers across Emergent to gain alignment on sound quality decisions. This position will support our Bayview site which operates on a 24/7 schedule.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Support/execute QA on the Floor program to provide quality oversight of manufacturing operations
• Work closely with technical, quality, and operational management to address any observations noted during execution
• Provide sound quality judgement in a fast-paced scenario, and escalate when needed
• Establish good rapport and work closely with manufacturing personnel to help drive a Quality mindset
• Support/execute real-time Batch Record review of executed/Master Batch Records on the floor
• Support/execute revision and creation of Standard Operating Procedures in document management system
• Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement, and QA
• Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
• Support the generation of QA operations metrics
• Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
• Receive assignments in the form of objectives to help achieve department goals
• Participate in company sponsored training
• Support regulatory and client audits
• Provide Quality input/support to investigations, CAPA’s and changes
• Support site inspection readiness strategy and activities
• Support internal audits per audit schedule
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 or equivalent years of experience in the field.
• Minimum 5 years’ experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records
• Preferred experience in biologic drug substance manufacture
• Experienced in application of GMP principles, Minimum of 2 years in an FDA or other equivalent regulated industry.
• Strong computer skills with the Microsoft Office product line.
• Moderate understanding of regulations governing document control and records management.
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
• Strong communication skills: oral/written and listening
• Ability to work individually and in a team environment
• Ability to work under pressure and analyze processes within scheduled timeframes
• Strong presentation skills, including written and verbal communication skills
• Experience in SAP and Technical Writing
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.