Specialist Ii, Quality Assurance

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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.

JOB SUMMARY

Reporting to the Senior Manager, Product Quality, this is a senior position requiring significant expertise / specialization in QA area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for Emergent (EBSI) combination product(s) (devices).

The role is responsible for (1) QA lead for internal and external projects (2) independent oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements (3) executing Quality Management System requirements in support of commercial and developmental programs (4) ensuring the realization of industry best practices for GxP and (5) serving as quality approval proxy as required

This position is responsible for performing various functions as an owner, reviewer and / or approver.

These functions include deviations, change controls, CAPAs, Complaints, Quality Risk Management validation and transfer protocols reports, trend evaluation and reporting, technical review design of history files (and its supporting documentation), review of critical procedures and processes, lead process changes and new product introduction, assist with regulatory responses, and develop and implement process improvements.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Individual will be assigned the responsibility for QA product / client relations and support while working with the client and different teams at the site.

Oversight of quality systems as they relate to the multiple product / client and processes

They will operate in a cohesive fashion

Interacts with senior leadership, direct manager, peers, departmental or non-departmental personnel, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions

Other :

Supervisory Responsibilities :

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

Minimum 8 years of cGMP experience including Manufacturing and Quality Assurance experience

Experience with quality risk management will be considered an asset.

PHYSICAL / MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

Physical / Mental Demands and Work Environment Characteristics :

Type / keyboard, visual acuity, stand, walk, sit, twist / turn, climb, reach outward, Use phone, fax, copier, computer.

Organize / coordinate, analyze / interpret, problem solve, make decisions, supervise, plan, communicate, and prepare written communications.

Hybrid Working Model :

A flexible working model is offered, where employees work partly in the physical workplace, and partly from home or another workspace.

Approximately 5% to 10% OR minimal travel to other sites.

May include international travel.

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 EMERGENTProtecting 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 IntegrityWe gain trust and confidence through ethics, quality, and compliance excellenceStand shoulder to shoulder no matter whatWe combine our best thinking and communicate openly to support each other.Own it alwaysEvery person at Emergent is engaged and accountable for delivering on our commitments.Break through thinkingWe take smart risks, pursue innovation and challenge ourselves to constantly improve.Compete where it countsWe set the right goals and respect each other as we conquer them together.

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