Quality Control Analyst 3

San Diego, CA, United States
May 16, 2019
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

The Analyst 3, Quality Control, will transfer, implement, continue to develop, and support the validation of Tocagen's QC testing procedures as required for the characterization and release of process development- and GMP-produced vector products. . It is expected that the Analyst 3, Quality Control will understand and work towards full GMP compliance in his/her day-to-day activities relevant to FDA, EMEA and ISO requirements.

Duties and responsibilities include but are not limited to:
  • Participate in internal and external activities for Tocagen's Quality Control program to allow production and release of clinical products consistent with established standards and procedures.
  • Support assay validation studies.
  • May perform the calibration/verification and IQ/OQ/PQ of laboratory equipment.
  • Qualify and maintain QC assay reagent stocks, reference standards, system suitability controls, and cell lines.
  • Work with internal Quality, Manufacturing, and Process Development resources and contract manufacturing organizations to ensure that all material sampling plans are complete and accurate in support of product release and characterization testing.
  • Prepare sample submissions for contract testing laboratories and work with contract laboratories to ensure adequate supplies of custom assay reagent, standard, and control materials.
  • Maintain inventories of diverse materials, including assay materials, regulated reserve samples, and vector lots for use in preclinical studies.
  • Author and revise SOPs in support of continuous process improvement within the Quality functional area.
  • Prepare protocols, perform experiments, and author reports in support of product characterization and compatibility.
  • Work towards full GMP compliance in his/her day-to-day activities.
  • Adhere to all Tocagen safety regulations.
  • Other duties as required.

Desired Knowledge and Abilities:

  • Knowledge of good manufacturing practices (GMPs), good laboratory practices (GLPs), USP testing methods and statistical processes as described in FDA regulations, ICH guidelines and EMEA guidance a plus.

Education and Experience:
  • Requires a Bachelor's degree in a scientific discipline (Molecular Biology, Biochemistry, Microbiology, etc.), with a minimum of 6 years of industrial lab experience with at least 4 of these years in a QC laboratory setting.
  • Requires experience with aseptic technique, media preparation and maintenance of mammalian cell lines.
  • Previous work with bioassays, qPCR, HPLC or ELISAs a requirement.
  • Strong collaboration and team building skills a necessity.
  • Ability to coordinate time-sensitive testing responsibilities with required documentation tasks in a fast-paced environment a necessity.