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Specialist I, QA Compliance

Location: 

Lansing, MI, US, 48906


 

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 

Provide Quality oversight and approval for all site qualification and validation activities, work orders, regulatory submissions and contract manufacturing operations.  Act as change control reviewer and support management of the change control system.  Provide quality guidance and approve the outcome of cGMP continuous improvement projects. Represent Emergent in regulatory communications including audits, submissions and other communications or meetings. 


ESSENTIAL FUNCTIONS

 

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

Quality Systems:
•    Provide Quality oversight of projects including: Equipment Qualification, Method Validation, Aseptic process validation, Process Validation, Work Order Review, Cleaning and Sterilization Validation, Shipping Validation, Regulatory Submissions, and Contract Manufacturing.
•    QA Representative for the Change Control System; reviewing and approving change requests, monitoring the timely completion of change activities, and performing final change approvals. 
•    Serve as reviewer and approver of documents such as qualification reports, change controls, validation & technical study protocols and other cGMP compliance documentation; ensuring data integrity and traceability, clarity of technical writing, compliance with SOP’s/regulations and suitability for review by regulatory authorities
•    Define, prepare, and communicate metrics, trends, and data summaries to senior management, as needed.
•    Work across all disciplines and functional areas to ensure that the site maintains a state of inspection readiness. 
•    Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the site.
•    Provide quality guidance to continuous improvement projects, product development, validation and transfer initiatives.
•    Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as appropriate.
•    Keep abreast of changes to quality regulations and guidelines, advising management of any business implications of these changes. 

Compliance and Regulatory:
•    Represent Quality Assurance and Emergent during FDA, EU and other regulatory agency inspections and customer relation activities with CDC, BARDA, DoD and HHS.
•    Complete FDA inspection response reports, monthly response updates and coordinated response and gap analysis teams
•    Performs final Quality Assurance approval of documentation for regulatory submission (e.g., BPDR’s, CMC, DMF, and related correspondence). 


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. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    Bachelor’s Degree in Biological Science or similar scientific field
•    Minimum of 8 years of parenteral pharmaceutical cGMP Quality experience with increasing responsibilities 
•    Previous experience working with FDA (CBER) and participating in regulatory agency inspections desired
•    Must have a full understanding and knowledge of cGMPs and EU Regulations.  
•    Must have Change Control, SOP, investigation and protocol writing skills and demonstrated ability to critically evaluate content and criticality of information.
•    Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for FDA review.  
•    Proficiency in MS Office products, SAP or comparable word-processing and spreadsheet skills are required


 

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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

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


Nearest Major Market: Lansing