Specialist I, Device Quality

Location
Hattiesburg, MS
Posted
Jul 09, 2021
Ref
731467000
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Contract


 

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.

 

SPECIALIST I, DEVICE QUALITY

 

Emergent BioSolutions is currently seeking a Specialist I, Device Quality for the Hattiesburg Location. The successful candidate will have a BA/BS (preferably in an Applied Science) or equivalent work experience, a minimum of 6 years of experience in a cGMP manufacturer, Aseptic Manufacturing, Medical Device Manufacturing, and previous Quality Assurance experience. The ideal candidate will exhibit strong interpersonal and communication skills, have the ability to work independently and in a team setting with minimal supervision and make sound decisions regarding compliance-related issues. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

Reporting to the Manager, Quality, this position is responsible for day-to-day implementation of Quality Systems and infrastructure appropriate for commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements. Individual executes Quality requirements for the oversight of manufacturing of medical devices, associated testing, and supply of medical device products ensuring the realization of industry best practices for GxP.

The Quality Specialist will review and prepare approvals for batch records, Deviations, CAPAs, Change Controls, and Supplier Notifications.  Individual will also serve as quality control back-up for material inspections, LIMS support, final device release testing, and manufacturing start-up verification as needed.

 

ESSENTIAL FUNCTIONS

 

  • Review and prepare for approval executed manufacturing records for filling, assembly, labeling, packaging, and shipping operations of products to ensure completeness, accuracy, and compliance. 
  • Review and prepare for approval production and testing procedures, batch records, specifications and validation protocols and reports.
  • Review and prepare for approval 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 OOS investigations.  Authorize resampling, retesting and determination of batch impact.
  • Independently resolve discrepancies found during review with Quality team.
  • Review and approve supplier 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 for medical devices 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.
  • 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.
  • Medical Device (ISO 13485:2016 and 21 CFR 820) Quality experience is preferred
  • 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.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

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.