Specialist I, Quality Control

Location: 

Rockville, MD, US, 20850


 

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

The QC Specialist I position supports the Quality Control group at Emergent BioSolutions Rockville Campus. The role requires knowledge and understanding of scientific concepts, practices and procedures within the biopharmaceutical field and a cGMP environment.

The QC Specialist is responsible for reviewing and scheduling activities in support of CGMP initiatives. The role will serve as a QC trainer and a coach for their team. Individuals should be able to work independently and participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments. In this role, Individuals will use soft skills, to work on QC schedules and to work with internal customers (EHS, Manufacturing and QA). People leader skills will be cultivated in this role. The individual will also assist in coordinating the preparation and conduct of study protocols, data analysis, reports, and standard operating procedures (SOPs) that support manufacturing activities and complex investigations to identify root causes and CAPAs to avoid reoccurrence. An individual in this role will serve as an SME for QC on cross functional Teams and will lead departmental, protocols, change controls, and tracking and trending reports.

II: ESSENTIAL FUNCTIONS

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

 

  • Assist the QC Manager with feasibility assessment of client projects
  • Write, review, revise, and approve SOP’s and Testing Standards as necessary.
  • Escalates issues through the proper channels.
  • Leads/Assists with complex investigations by obtaining root cause and implementing changes
  • Resource for technical knowledge of current assays
  • Trains QC analyst
  • Basic understanding of compliance/guidance/regulation pertaining CGMP manufacturing.
  • Participate in investigations of OOS results and other related studies.
  • Verifies and enter results in LIMS, and reviews and approves QC Data and Logs
  • Practice Good Documentation per the Standard Operating Procedures.
  • Applies Environmental/Analytical knowledge to support change and risk management
  • Support department compliance and productivity goals
  • Identify and implement continuous improvement opportunities to reduce non-value-added work or complexity.
  • Support departmental goals and actively participate in department level meetings.
  • Track time worked per project, and can train QC analysts     
  • Detailed oriented – Able to complete required tasks and associated documentation with minimal error.
  • Adaptability – Maintain positive attitude in a changing work environment.
  • Communication – Effectively communicates with all levels of Emergent Employees

 

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.

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:       BS in Microbiology/Biology/Chemistry or related field

Experience:      5+ years (MS with 3+ years) in Pharmaceutical or Biotechnology with emphasis in aseptic processing, Microbiology, Environmental Monitoring, Critical Utilities. Proven track record of achievement and sustained performance in a cGMP/GLP environment. Capable Project Leader who has shown ability to manage complexity. Strong technical and communication skills: oral/written and listening. Personal Competencies: Self – awareness, Integrity, Team Player, Creative and Flexible  

Skills:              Knowledge of MS Word, Excel, LIMS, and PowerPoint.

 

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: Washington DC