Analyst III, QC Data Reviewer

Location
Baltimore (Bayview), MD, US
Posted
Oct 12, 2020
Ref
661228500
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

Perform assay technical and data integrity review as required to support QC lab operations including QC Analytical, QC Raw Material and QC Microbiology as well as QC testing performed for method validations and qualification. Review of lab and equipment notebooks for GDP and compliance to internal procedures and GXP practices.

ESSENTIAL FUNCTIONS
  • Be familiar with a wide variety of analytical/biological/Compendia methodologies and techniques
  • Perform detailed technical and data integrity review of complex QC data; perform LIMS review as assigned
  • Adhere to all effective STM's/SOPs and document work consistent with cGMP requirements
  • Contribute to troubleshooting/laboratory investigation efforts with supervisory guidance
  • Contribute to SOPs, protocols, technical studies, and reports under supervisory or senior analyst guidance
  • Identify opportunities for improvements within QA/QC procedures and documentation
  • Train and provide assistance in basic QA tasks to junior staff; provide training to peers in an effective manner
  • Independently move projects forward; guide project progression through appropriate decision making
  • Report compliance concerns to Supervisor/Manager QA and appropriate area management
  • Support coverage of operational activities outside of core working hours
  • Review all documentation in accordance to governing procedures.
  • Investigate any concerns and/or discrepancies and ensure appropriate action is taken
  • Compile and collate documentation packages
  • Review and assessment of (assigned) QC investigations
  • Support the QA Manager by organizing tasks for the assay review team
  • 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.


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
  • University degree or technical diploma in chemistry, biology or related field of study
  • Minimum of five years directly related experience in a recognized professional or technical/scientific field. Experience in a pharmaceutical cGMP environment is an asset, but is not required.
  • Proficient in Microsoft Office - Word, Excel, PowerPoint
  • Proficient understanding of pharmaceutical GLPs and GMPs
  • Ability to work in a fast paced and highly regulated environment
  • WHMIS and biohazard safety awareness
  • Comprehensive knowledge of laboratory techniques and safety precautions
  • Ability to work in a faced paced and highly regulated environment
  • Able to multi-task and adapt to changing priorities
  • Competent in laboratory safety and generally accepted lab practice, including maintaining adequate written laboratory records
  • Able to interpret analytical data to support research and development work
  • Able to contribute ideas/solutions to aid in troubleshooting and investigations
  • Have strong communication skills; ability to articulate effectively in both written and verbal forms.
  • Have strong organizational and interpersonal skills and the ability to work collaboratively with others.
  • Strong leadership skills, independence and initiative.


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.