Qa Specialist Ii

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QA Specialist II (Senior) - External Manufacturing, Combination Products & Quality Compliance
Location:
Dublin, IE
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
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.
II.
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

• Individual will be liaison between Quality Assurance and other departments to ensure Quality Assurance commitments are completed and to identify areas to improve data trends or process/ product outcomes.
They will operate in a cohesive fashion

• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals

• Quality oversight, with management support of external manufacturing, warehousing operations, validation, verification, and quality control of combination product(s) (devices) at Emergent

• Responsible for product release, including batch documentation review, management of changes, complaints, deviations, validations, and product annual reviews to ensure completeness, accuracy, and compliance

• Lead or assist in continuous improvement projects as assigned.
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

• Perform, review and approve risk assessments and propose risk mitigations and or corrective/preventive actions to reduce process/ product variation as part of the Quality Risk Management program

• Lead Implementation of appropriate CAPA or risk mitigations for Quality related items

• QA oversight of Validation activities including reviewing and approving validation (including Continued Process Verification (CPV)) and stability protocols and reports

• QA oversight of product related stability activities including new and routine annual requirements

• Performing review of Design History Files (DHF) for combination products and relevant supporting documentation

• Write and implement Quality Plans (where appropriate) to ensure compliance to QMS

• Trend evaluation and reporting and SPC analysis of trends to determine (when possible) proactive approaches to advert future quality issues with process/ product.

• Annual product review generation, review and approval

• Technical review and approval of critical SOPs and processes

• Coordinate and work with Project Managers and Technical Transfer personnel on process changes and new product introduction

• Support design and development activities with combination products

• Quality oversight of Regulatory Affairs activities including with regulatory submissions

• Developing and implementing process improvements
Other:

• Participates in and lead Quality Assurance Process Improvement Teams

• Participates in and lead inspection readiness, audits and regulatory inspections as needed

• Provide guidance for ISO 13485 and ISO 14971 requirements for combination products

• Other assigned responsibilities as established by Manager
Supervisory Responsibilities:

• No direct reports but routinely act as a QA lead and provide guidance to other departmental personnel

• Routinely represents QA management in direct discussions with clients.
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

• Bachelors of Science (Pharmacy, Chemistry, Microbiology or related field), Advanced degree (M.S., Ph.D., MBA) preferred.
Minimum 8 years of cGMP experience including Manufacturing and Quality Assurance experience

• 2-3 years in a senior or leadership Quality Assurance role

• Qualified Person experience preferable

• Broad experience and thorough understanding of international GMP Quality Management System regulations for drugs and devices including ICH Guidelines, ISO 13485, FDA 21 CFR Parts 210, 211 and 820, European (EudraLex Volume 4) and Health Canada GMPs

• Demonstrated experience owning, driving and leading Quality initiatives

• Demonstrated experience working independently with internal and external partners

• Experience as process owner for deviation, CAPA, change management, and self-inspection programs as well as managing 3rd party audits and inspections is preferable.
Experience with quality risk management will be considered an asset.

• Must be a self-starter with ability to work independently

• Ability to manage and deliver multiple priorities, projects and tasks in a dynamic environment using own initiative with little instruction on routine work, general instructions on new assignments

• Ability to operate efficiently in a complex matrix organization and international environment making sound decisions regarding compliance-related issues with minimal supervision.

• Strong mature leadership and interpersonal influencing skills showing personal/departmental accountability and responsibility.

• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.

• Ability to lead Change Management activities and strong Project Management knowledge

• Excellent communication skills, both written and verbal

• 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
IV.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

• The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

• The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

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