Specialist I, QC

Location
Baltimore (Bayview), MD, US
Posted
Oct 06, 2020
Ref
653573200
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

Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department. Performs review of in-process, release, and stability testing data to support a GMP facility and manufacturing.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
  • Provides review and feedback to developmental labs in support of analytical assay development, transfer and qualification/ validation studies to meet regulatory and ICH guidelines.
  • Assists with execution, documentation and review of testing as required to support product release, stability, and validation studies.
  • Leads or coordinates complex projects with other departments and interacts with other department personnel to accomplish objectives.
  • Leads LIR, OOS, and QC based deviations investigations; designs and implements corrective action plans to address deficiencies.
  • Ensures the reliability and accuracy of the computer databases, and paper files.
  • Writes proposals and/or summary documents suitable for external distribution or for regulatory submission that collaborate data from multiple sources.
  • Provides technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments as a member of a cross-functional team.
  • Provides information in support of department budget. Contributes to departmental strategy and provides input on lab requirements and improvements.

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
  • Bachelor's degree in chemistry, biology or related field of study.
  • Minimum of five years directly related experience in the pharmaceutical/biopharmaceutical or related industry.
  • 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.
  • Extensive knowledge of biomolecular analysis; practical experience with a range of analytical instrumentation / methodology including such methodologies as FTIR, GC, HPLC, ELISA, immunological assays, spectrophotometric analysis, USP/EP testing, wet chemistry.
  • Proficient in Microsoft Office - Word, Excel, PowerPoint.
  • Comprehensive knowledge of pharmaceutical GLPs and GMPs.
  • Comprehensive knowledge of laboratory techniques and safety precautions.
  • Comprehensive knowledge of regulatory/industry guidance.


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.