QC Associate I
San Diego Metro Area, California
- Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods.
- Follow established protocols and SOP s to test raw material and components for QC acceptability.
- Perform daily assignments following written procedures and SOP s.
- Ability to troubleshoot instrument problems when necessary.
- Conducting visual and measurement tests; rejecting and returning unacceptable materials.
- Approves in-process production by confirming specifications; communication required adjustments to supervisor and generating NCR s and Change Orders when necessary.
- Handles incoming inspection in a timely manner which includes but not limited to sample analysis, batch record review, historical trend reviews, and official documentation findings.
- Careful documentation of lab procedures.
- Ability to follow written procedures
- Flexibility with schedule may be required.
- Preperation, daily maintenance, and use of next-generation sequencing instruments and equipment.
- Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
- Requires a basic knowledge of and application of principles, theories and practices of the chemist profession.
- Requires basic communication skills. Periodic contacts with other departments or individuals outside of the organization that requires giving or obtaining routine information related work being done.
- Flexible: able to respond quickly to shifting priorities and meet deadlines
- Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, etc. required. Experience with DNA or RNA sample preparation, sequencing, qPCR, robotics and/or Illumina technology is a plus.
- Experience and familiarity with instrumentation a plus.
- Ability to understand and follow work instructions and perform molecular biology assays with minimal guidance after initial training.
- Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
- Knowledge of GMP documentation, required.
- Demonstrated attention to details and accuracy, required.
- BS/MS in Biology/Molecular Biology, biochemistry, chemistry or related discipline
- 2 to 5 years of industry experience with Functional analysis QC of molecular-biology-based assays preferred, other QC, R&D or manufacturing experience will be considered.