Quality Control Analyst - Abzena

Quality Control Analyst

Location: San Diego, CA
Area: Quality

Position Responsibilities:

  • Analyze raw materials, in-process materials, intermediates, APIs and finished products as necessary.
  • Sample materials for QC testing, retains and stability.
  • Assist in testing of stability samples, keep stability program schedule, trend test results and investigate out of specification results.
  • Perform routine and in-process environmental monitoring of viable air, viable surface, and total airborne particulates of the production facilities and aseptic filling operations.
  • Report and investigate OOS results; determine root cause, propose and implement corrective actions as appropriate.
  • Initiate and participate in the investigations into environmental monitoring excursions to assess any potential impact to product.
  • Assist in qualification and validation of analytical methods for release of final product of phase II clinical material.
  • Assist in writing and revising standard test methods, specifications, method validation protocols and reports.
  • Assist with technical transfer of test methods for release of raw materials, in-process materials, intermediates, APIs and finished products.
  • Performs other related duties as required.

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with PacificGMP’s policies and procedures.
  • Adheres to quality standards set by regulations and PacificGMP policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of PacificGMP’s business.
  • Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting PacificGMP’s strategic goals.
  • Travels as needed.

Qualifications/Skills Required:

  • BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.).
  • Minimum three (3) years experience working in a lab.
  • Required experience in assay development/validation.
  • Required experience in optimization, development and validation of analytical and microbiological assays.
  • Experience with analytical methods such as HPLC and molecular biology techniques (PCR, immunoassays, SDS-PAGE, ELISA and functional assays) is a plus.
  • Experience with understanding basic principles of HPLC and plate based assays such as ELISAs.
  • Experience in environmental monitoring under static and dynamic conditions and personnel monitoring under GMP conditions.
  • Knowledge of and experience in GMP, following STM’s, or willingness to become GMP proficient.
  • Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
  • Ability to use routine laboratory equipment including, but not limited to, HPLCs, plate readers and electrophoresis equipment.
  • Ability to work well under pressure, multi-task, be organized and have good communication skills.
Interested in our services? Get In Touch