Emergent Biosolutions Hiring For Specialist I, External Manufacturing Quality (Tablets & Solid Oral Dosage) at Dublin, County Dublin Full Time

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.

Job Summary

The Specialist is responsible for day-to-day implementation of Quality Systems and infrastructure appropriate for commercial manufacture in compliance with Current Good Manufacturing Practice (CGMP) requirements. Individual executes Quality requirements for the oversight of contract manufacturer of Emergent Products, associated testing, and supply of medical device products ensuring the realization of industry best practices for GxP. The Specialist will review and prepare for approval batch records, Deviations, CAPAs, Change Controls, Supplier Notifications. Individual will also serve as quality approval proxy as needed, and support supplier audit activities with approximately 15% domestic and international travel. The ideal candidate will have experience with solid oral dosage forms.

Essential Functions

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

Review and prepare for approval CMO executed manufacturing records for formulation, filling, assembly, and labeling, packaging and shipping operations of products to ensure completeness, accuracy and compliance

Review and prepare for approval of CMO production and testing procedures, batch records, specifications and validation protocols and reports.

Review and prepare for approval CMO related production deviations, conducting assessment of batch impact and final decision recommendations for batch disposition. Coordinate and lead cross functional teams to perform high level non-conformance investigations, including root cause analysis. Review and approval of CMO related OOS investigations. Authorize resampling, retesting, and determination of batch impact

Independently resolve discrepancies found during review with CMO Quality team

Review and approve supplier and CMO change notifications. Author and coordinate applicable changes through the Emergent Change Management process as required

Review various types of documentation to ensure completeness, accuracy, and compliance

This includes SOP revisions, Protocols, Data Sets, Material Specifications, Validation reports

Contribute to the continuous improvement of Quality review/ release processes

Support the stability program as required, facilitating communication and data acquisition between supply chain, contract manufacturers and stability program coordinator

Collaborate to support approval of Quality Technical agreements for contract manufacturing, testing, holding/ distribution facilities, and raw material suppliers

Facilitate discussions between Emergent and CMO Quality organizations to establish responsibilities for Quality related functions

Serve as Quality Approval Proxy for all areas noted above as required (i.e., Deviation, CAPA, Batch Record documentation, Batch Release, etc.)

Assist audit group with scheduling, preparation, and completion of audits for contracted services and material suppliers

Review and approve technology transfer activities across contract organizations for production and testing

This includes review of CMO validation protocols and reports for equipment, process and test method enhancements

Support regulatory department with any regulatory filings associated with new market authorizations, annual reports and change supplements

Work with translation service providers to conduct translation activities for manufacturing, testing, qualification/ validation activities

Responsible for identifying defects and have the authority to report device defects at any time

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.

Education, Experience, & Skills

BA/BS (preferably in an Applied Science) or equivalent work experience

Minimum 6 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Medical Device Manufacturing and previous Quality Assurance experience

Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred

Candidate must exhibit strong interpersonal and communication skills

Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents

Strong oral and written communication skills

Ability to work independently and in a team setting with minimal supervision

Ability to make sound decisions regarding compliance-related issues with minimal supervision

Strong Leadership, high level of personal/departmental accountability and responsibility

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.

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.