Applicants will be considered with any experience level ranging from level I to III to fill 2 openings in the QC Department at
a biotech firm in the Mira Mesa area.

• REQUIRED skills and experience: HPLC Analytical Experience, QC Testing Experience and GMP knowledge.
• Any Science Degree will be accepted but a Chemistry Degree is highly preferred.

Summary: Oversees and evaluates all processes leading to the accurate and reliable generation of data for a biologic product
or medical device.

Essential Duties and Responsibilities

• Oversees and performs prescribed testing for product release in accordance with established procedures.
• Oversees and performs prescribed procedures, sample collections, customer complaint testing, stability and performance testing to monitor adherence to quality control specifications.
• Participates in the implementation and execution of validation studies on performance assays and analytic
  instrumentation to ensure consistency of data production and concurrence with manufacturer and national standard reference
  values.
• Participates in the design and implementation of stability protocols, performs statistical analyses, and assists in the
  review of stability protocols and final packages.
• Designs databases for entry of data in regards to data evaluation.
• Serves as liaison/team member with QA, regulatory affairs, research and development, and manufacturing
  departments for routine issues.
• Participates in the transfer of new products/methods.
• Trains new employees and coworkers as assigned by supervisor/laboratory coordinator.
• Performs other related duties as assigned.

Education and/or Experience:

• Bachelor's degree or equivalent in Chemistry, Biology, Microbiology or related field
• Three years related experience and/or training; or equivalent combination of education and experience.
• Certified Quality Technician desirable.
• Knowledge of GMP/GLP required.