Analyst I, Quality Assurance

Location: 

Lansing, MI, US, 48906


 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY 
The Quality Assurance Analyst 1 is an entry level quality professional that is responsible for Quality oversight of processes in manufacturing/ production and/or release laboratories. 

This position interacts with Manufacturing, Quality Control, Production Planning, Emergent partners and Auditors/Inspectors to ensure required inputs for the manufacturing process meet cGMP requirements within established timelines. 


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

 

•    Provide direct quality “on the floor” support and oversight to with oversight from QA management 
•    Follows written instructions in the routine review of laboratory and production records in accordance with Emergent standard operating procedures and good documentation practices (GDP) 
•    Perform label control processes such as counting, verification, issuance, receipt and reconciliation of components
•    Supports Minor Non-conformance investigations which may contain basic root cause analysis
•    Uses existing procedures to solve routine or standard problems
•    Basic conceptual knowledge and practices associated with Document Review and Product Disposition
•    Recognizes errors in records and resolves them in a timely manner
•    Supports basic improvement projects 
•    Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines.


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 (in an applied science preferred) or equivalent work experience.
•    1-3 years of experience working in an FDA regulated industry preferred 
•    Experience with quality assurance preferred 
•    Gowning for BSL-2 and BSL-3 and Aseptic environments preferred
•    Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
•    Ability to make sound decisions regarding compliance-related issues with supervision
•    High level of personal/departmental accountability and responsibility.
•    Familiarity with pharmaceutical industry guidance (ICH, CFR 21.210-211, USP) 
 

 

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

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


Nearest Major Market: Lansing