21 days old

Analyst III, Quality, QA on the Floor QC

Emergent BioSolutions Inc.
Baltimore, MD 21202


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.

I. JOB SUMMARY
This role is responsible for monitoring Quality Control laboratories, reviewing GMP records/data, and interacting with Batch Review, Quality Control, and Quality Engineering teams to provide guidance necessary to maintain and improve CGMP compliance at the facility.


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

 Conduct Analytical and Micro Labs in-process audits and walkthroughs
 Perform Quality on the Floor batch record review
 Monitor key Quality Control laboratory processes
 Review logbooks, reports, data integrity, equipment audit trails, and GMP records
 Participate in daily QA and QC tier meetings
 Maintain company quality and safety standards in the labs
 Author/revise standard operating procedures (SOPs) and other controlled documents
 Support QC Quality on the Floor improvement initiatives
 Implement solutions for issues affecting QA and Quality Control operations
 Initiate deviations and assist in area investigations
 Train/mentor QC personnel to resolve open concerns resulting from record reviews, walkthrough observations, and deviations
This will be a day shift Monday thru Friday position. Overtime and weekend work may be required based on business needs.

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 managements assignment of essential functions.


III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS or BA degree in Science or Engineering with 2-5 years of GMP experience; QA/QC role preferred
 Ability to make sound compliance-related decisions with minimal supervision
 Must possess strong attention to detail.
 Ability to navigate lab equipment software and computer programs such as Veeva (Document Management System) and SAP (ERP System).
 Proficient knowledge of CGMP.
 Strong communication (written and verbal) and organizational skills.
 Ability to independently manage multiple priorities in a dynamic environment.
 High level of personal/departmental accountability and responsibility.
 Excellent problem-solving and teamwork skills.
 Proficient at resolving issues in creative and innovative ways.
 Exercises good judgment in selecting methods/techniques to achieve positive results.
 Understand and respond appropriately to a diverse population.


IV.  PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

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Posted: 2020-12-31 Expires: 2021-02-07

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Analyst III, Quality, QA on the Floor QC

Emergent BioSolutions Inc.
Baltimore, MD 21202

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