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Analyst I, QC Support

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 Analyst I for this position will performing tasks associated with the creation of stability protocols, analytical and micro data review, pull stability samples, and coordinate activities with local and third party laboratories, inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods.  
The Analyst I also maintains laboratory cleanliness and performs preventative maintenance on laboratory equipment per established procedures.

 

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

 

•    Assist with Emergent’s product stability program ensuring each is in alignment with CFR and ICH guidelines, by reviewing industry guidance
•    Create and execute stability protocols (all Emergent products, raw materials, reference standards, from product development, clinical trials I – III, commercial stage and end of product life cycle “discontinuation”) which includes:

  • Write stability protocols
  • Initiate placement of samples and inventory initiation
  • Pull and submit samples to the laboratories
  • Ship samples for testing at contract laboratories
  • Oversight of testing to ensure timely completion with laboratories
  • Perform routine inventory of all stability samples
  • Enter stability data and maintain stability data sets

•    Maintain the Stability pull calendar to ensure all pulls are made on time
•    Clean and maintain stability chambers and laboratory space (including mopping/wiping with cleaning agents, ensuring proper function, tag out non-functioning equipment, etc.)
•    Assist with various QC projects as necessary
•    Create new SOP’s and revise existing SOPs; write deviations, CAPA’s, and Change Controls as needed. 
•    Perform incoming inspections which includes:

  • Following cleanroom behavior and gowning
  • Material sampling
  • Performing Physical Characteristics Testing

•    Perform AQL inspections
•    Assist with inventory reconciliation

 

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
•    Associates Degree or equivalent level of skill and experience
•    1-3 years experience within a cGMP / FDA / Pharmaceutical environment.  
•    Previous experience working with stability programs/samples is desired but not required. 
•    Strong written and oral communications skills
•    Strong initiative, organization and ability to work independently
•    Must have strong computer skills with MS Word, Excel, and Adobe
•    Knowledge of LIMS systems

 

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