Specialist I, Quality Assurance

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 
The Quality Assurance Manufacturing Specialist I is an experienced quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories. 

 

The Specialist position operates with considerable latitude, and is responsible for system level oversight and complex root cause analysis Quality System work.  The specialist also serves as a subject matter expert in Emergent quality systems and directly interacts with regulators during on-site inspections. This position Frequently interacts with department managers, internal customers, and other cross functional peers to gain alignment and make quality related decisions.

 

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

 

•    Provide quality on the floor support and oversight to help resolve manufacturing issues of moderate to high complexity without oversight
•    Performs audits of the manufacturing facilities and laboratories to ensure compliance with internal Emergent procedures and cGMPs 
•    Reviews Product Manufacturing and Testing records to ensure product specification and process requirements are consistently met in accordance with Emergent standard operating procedures
•    Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity
•    Define, prepare and communicate performance metrics and trend analyses to senior management 
•    Supports Major and Critical Non-conformance investigations inclusive of a detailed root cause analysis and corrective actions
•    Serves as a decision-maker on significant procedure and site projects
•    Coordinate/lead cross functional teams in process mapping and other exercises designed to facilitate process and system understanding
•    Serve as Quality representative over an integrated process team and represent Quality Assurance as part of the Value Stream Management Committee 
•    Coordinate the completion of product release deliverables and ensure product release goals are met by Quality Assurance
•    Implements continuous improvements projects in support of Quality Assurance and Manufacturing/QC
•    May serve as system owner for one or more quality systems or be the lead of an integrated process team
•    Directly supports internal and external inspections and audits by directly interacting with auditors as a subject matter expert for quality systems
•    Responds to customer inquiries and complaints. Investigates customer complaints for root cause and takes appropriate action as required

 

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

•    BA/BS (preferably in an applied science)
•    >8 years of experience working in an FDA regulated industry with at least 5 years of experience within Quality Assurance 
•    Experience with aseptic processes, clean room gowning, and Pharmaceutical quality system work preferred
•    Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
•    Familiarity with performing Root Cause Analysis, CAPA, and Change Control. 
•    Ability to make sound decisions regarding high complexity compliance-related issues with low supervision.
•    High level of personal/departmental accountability and responsibility.
•    Strong Understanding of pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) and current industry trends. 
 

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

 

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