Supervisor, QC Testing

Location
Rockville, MD, US
Posted
Jun 08, 2021
Ref
721918500
Discipline
Quality, Quality Control
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 Supervisor, position supports the Quality Control group at Emergent BioSolutions Rockville Campus. The QC Supervisor is responsible for reviewing and scheduling activities in support of the Microbiology, Environmental Monitoring, Analytical (including testing and method transfer), Critical Utility testing programs, Manufacturing Support Testing, and supporting quality initiatives. Individuals will manage teams of 4-7 analysts. An individual in this role will serve as a QC trainer and a coach for their team. Analyst's performance review, goal planning and compensation planning will be the responsibility of an individual in this role.

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
  • Reviews/Approves microbiological / analytical work per SOPs, and applicable protocols
  • Informs supervisor/manager upon observing OOS, OOL, or generation of deviations
  • Leads/Assists with complex investigations by obtaining root cause and implementing changes
  • Writes, reviews, revises, and approves SOP's and Testing Standards as necessary
  • Trains QC analyst
  • Reviews, analyzes, interprets, reports, and approves data
  • Applies Environmental/Analytical knowledge to support change and risk management
  • Support department compliance and productivity goals
  • Track time Individual and Team time worked per project and holiday
  • Identify and implement continuous improvement opportunities to reduce non-value-added work or complexity.
  • May require work on weekends and nights, travel, or work with 3rd party vendor
  • 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 manufacturing and support staff.


*R equires vaccination against different viruses including Vaccinia virus.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

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


Experience:
  • 5+ years (MS with 3+ years) in the Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation, and manufacturing processes.
  • Proven track record of achievement and sustained performance in a cGMP/GLP environment.
  • 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.

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.

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