Specialist I, QA

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I. JOB SUMMARY

The Specialist I, Quality Assurance is responsible for independent QA oversight in support of commercial product manufacturing at the site managing activities for one or more Quality System. The Specialist will provide a broad scope of technical knowledge to analyze risk,

troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management.

The individual will provide support to ensure change management, CAPA, deviations, and effectiveness checks, are conducted in accordance with established policies and procedures.

The position requires strong technical knowledge of Change Management and enterprise systems, GMP processes, and risk management.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.• Provide leadership and guidance through critical review of Change Controls to ensure completeness, accuracy, and compliance.• Lead 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.• Review documentation including but not limited to regulatory submissions, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls.• Analyze complex information and develop solutions that are compliant with the quality system objectives.• Contribute to inspection readiness strategy and activities and serve as a subject matter expert in quality systems.• Prepare and review Management Review metrics for identification of negative trends.• Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team.• Frequently interacts with senior leadership, direct manager, peers, and other cross functional peers across Emergent to gain alignment on sound quality decisions.• Represents Quality in key decision-making regarding requirements for CAPEX and validation projects. • Manages the site change control program regarding new product introduction, equipment, and facilities. • Has a broad expertise or unique knowledge, uses skills to contribute to development of company objectives. Achieves goals in creative and effective ways. • Serves as change agent for continuous improvement within the scope of work. • Provide support during regulatory and internal inspection activities as needed. • Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.• Must work independently and manage time.• Must be detail oriented and conduct thorough reviews and approve documents on behalf of Quality Systems.• Review and approve other documents as needed.• Support and partner GMP departments across the site.

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• Bachelor's degree in science or engineering from an accredited university or college• A minimum of seven (7) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof • Experience with Change Management, investigations into deviations and determination of impact, root cause, and corrective actions • Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage, and distribution, RODI water system, and Temperature Controlled Units (e.g., refrigerators, freezers, and incubators) is an advantage. • Veeva EQMS experience for change management is required.• Demonstrated success in independent judgment, technical proficiency, and collaboration with others in a cGMP environment. • Must be a team player and able to work cross-functionally in a matrixed environment. • Must have excellent written and verbal communications skills. • Excellent organizational and interpersonal skills. • Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions. • Demonstrated ability to manage multiple activities while maintaining a high level of organization. • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision. • Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.