Supervisor, QC, First Shift

Location
Baltimore (Bayview), MD, US
Posted
Oct 25, 2020
Ref
656557200
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.

JOB SUMMARY

Supervision and oversight of routine and non-routine microbiological activities. This includes scheduling and execution of the environmental monitoring testing program, utility testing program, raw material, in-process, and product release testing requirements and well as ensuring adequate resources to support non-routine method qualification, area re-qualification, growth promotion, and reagent control activities.

ESSENTIAL FUNCTIONS
  • Responsible for scheduling, execution and quality documentation of the environmental monitoring program. Provides support for alert and action level event investigations.
  • Responsible for scheduling, execution and quality documentation of the utility monitoring program. Provides support for alert and action level event investigations
  • Responsible for scheduling, execution and quality documentation of raw material, in-process, and product release testing. Provides support for alert and action level event investigations
  • Provide process monitoring support for aseptic processes.
  • Responsible for scheduling and execution of test data review in a timely manner
  • Ensure equipment and materials needed to support environmental and utility monitoring programs are procured, tested and available for use.
  • Ensure that lab activities are conducted according to safety guidelines, policies and legislation.
  • Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
  • Perform administrative duties such as approval of time documentation.
  • Responsible for professional development, goal setting and performance review of lab staff.
  • Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments.
  • Provide information in support of department budget. Contribute to departmental strategy and provide input on lab requirements and improvements.

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
  • University degree in chemistry, biology or related field of study.
  • Minimum of five years directly related experience in a recognized professional or technical/scientific field, with experience in a leadership or supervisory role.
  • Experience in an operating in pharmaceutical cGMP environment is required.
  • Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
  • Proficient and professional communicator, verbally and in writing.
  • Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
  • Strong organizational and interpersonal skills and the ability to work collaboratively with others.
  • Proficient in complex procedures and problem solving.
  • Strong commitment to teamwork, proven leadership skills, independence and initiative.
  • Proficient in Microsoft Office - Word, Excel, PowerPoint
  • Comprehensive knowledge of pharmaceutical GLPs and GMPs
  • Comprehensive knowledge of laboratory techniques and safety precautions
  • Experience with LIMS and SAP software applications is desired.


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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.