Quality Lab Associate
The position reports to the QAQC Manager at our manufacturing facility in Apex, NC. The Quality Lab Associate will be responsible for the biological and chemical evaluation of our final product, intermediate products, and raw materials, using equipment at our production facility.
Responsibilities & Principal Activities:
- Perform all QC assays and raw material specification tests.
- Write and establish specifications.
- Write Standard Operating Procedures.
- Use critical thinking skills to troubleshoot assay and instrument problems.
- Assist in the validation of QC assays.
- Train Assistants and Interns in SOP and QC assays.
- Document results in lab notebooks and batch sheets and review for corrections.
- Issue Certificates of Analysis for completed batches.
- Communicate with QAQC team.
- Maintain and calibrate laboratory equipment and instrumentation.
- Assist in QC method evaluation, development, and improvement.
- Approve Certificates of Analysis for raw materials and maintain files for COA.
- Keep all lab areas clean and orderly. Replenish supplies.
- Follow all safety policies.
- Ensure the facility is maintained and auditable to HACCP, FAMI-QS and GLP / GMP.
Education / Qualifications / Background Requirements:
- Associate’s degree in a field related to biotechnology preferred or Bioworks certification with appropriate experience.
- Current knowledge of GLP standards and competency in GLP practices.
- 2+ years of experience in the field or in a related area preferred.
Behaviors & Key Performance Factors:
- Knowledge of standard concepts, practices, and procedures within the biotech field.
- Competency with QC/Laboratory practices.
- Demonstrates proactive thinking and problem solving.
- High attention to detail.
- Ability to accomplish the described duties using appropriate machines and test equipment.
- Relies on experience and judgment to plan and accomplish goals.
Résumés (with position title in the headline) may be emailed directly to firstname.lastname@example.org