QC Reviewer

Ology Bioservices, Inc.
Job Description
DESCRIPTION

QC Reviewer, reports to the QC Support Services Manager and performs a range work activities including:

  • Principal responsibility is to perform QC level review of data generated in the QC labs prior to subsequent QA review.
  • Following SOPs in performing cGMP data review generated by QC laboratories.
  • Assist with the development and writing of Test Methods, SOPs, Work Instructions and all other documentation required in accordance with established and current quality requirements.
  • Participating in the review of maintenance, qualification and calibration records and documents of laboratory equipment in QC.
  • Participating in Laboratory administration, including Out of Specification and non-conformances arising, progression of change controls, laboratory investigations/audits, SOP reviews and closure of assigned activities in QC.
  • Review of environmental monitoring sampling and testing performed by QC Micro. Participating in review and approvals of method qualification and validation of QC procedures as needed.
  • Co-ordinate with Quality Control laboratory managers and ensure timely release of material/ stability data to meet the organization’s goals.
  • Prior experiences with data tracking software systems such as LIMS, EMPOWER and/or MODA is preferred.
  • Performance of test method activities as needed.
  • Performance or Assistance with IOQ/IOPQ validation activities as needed.
  • Prior experience with biological testing including TCID-50, CE-SDS, PCR, Cell-based bioassays and ELISA highly preferred

 

*All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.

POSITION REQUIREMENTS
  • Bachelor’s degree in Biochemistry, Biology or Microbiology or related field
  • At least 4 years of experience in a GMP laboratory
  • Must be familiar with cGMP/GLP practices and ICH and FDA Guidelines.
  • Strong verbal/written and interpersonal communication skills as a team player and willing to work in an environment where individual initiative, collaboration and accountability are valued.
  • Ability to work independently with minimal supervision.
NUMBER OF OPENINGS 1  
EOE STATEMENT Ology Bioservices,is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, or military/veteran status or any other characteristics protected by law.

EEO Minorities/Women/Disabled/Veterans  
ABOUT THE ORGANIZATION Thank you for your interest in joining the Ology Bioservices team! We believe we have the most talented and committed employees in the industry with decades of combined experience in manufacturing, developing and licensing vaccines and protein/antibody therapeutics.
Ology Bioservices is a full-service Contract Development Manufacturing Organization specializing in biologic drug substance manufacturing from early stage through commercial product. The company has 183,000 square feet of manufacturing, process development and QA/QC space in our state of the art Advanced Development and Manufacturing ADM) facility in Florida. Ology Bio has 20 years of experience developing and manufacturing drugs and biologics for the US Government, and over $500M in government contracts awarded over that time.
The company expanded to Commercial Manufacturing upon the move into the new facility in early 2017. Our infrastructure provides unique services to our clients, including full regulatory support from preclinical through licensure, clinical trial operational support and bioanalytical testing, as well as cGMP manufacturing up to Biosafety Level 3 (BSL3).
We offer outstanding career growth opportunities, excellent fringe benefits, and competitive pay.
We are an Equal opportunity Employer
AA/EEO Minorities/Women/Disabled/Veterans  
POSITION QC Reviewer  
LOCATION Alachua  
Contact Information