Quality Control Associate II
MUST HAVE Flow Cytometry and qPCR EXPERIENCE
- Perform chemical, biochemical, biological and/or microbiological testing, assays and procedures related to quality control (QC) by following Standard Operating Procedures (SOPs) in order to obtain results that allow for release of patient product(s).
- Document performance of analytical methods in order to be consistent with current GMP and documentation practices.
- Support creation of analytical method protocols and reports to support method development, method qualification, stability study, and assay optimization in collaboration with PI and QC project lead. Adhere to cGMP compliance requirements to maintain inspection-ready state.
- Collect, interpret and perform basic analyses and reporting of data from test results. Recommend modifications for optimization or clarification of test procedures, protocols, and assays in collaboration with quality control, quality systems management, Principal Investigator (PI) and project team.
- Manage, maintain, monitor, and order QC raw materials and supplies
- Monitor and troubleshoot pertinent equipment; Ensure equipment qualification, preventive maintenance, and calibration are performed per requirement and by due date. Coordinate equipment implementation for use and decommissioning activities.
- Participate in the investigation of out-of-specification and/or non-conforming test results.
- Prepare deviation reports per SOPs with input and oversight from supervisor. Implement prevention or corrective actions based on supervisor feedback.
- Participate in the development and maintenance of QC related SOPs, test procedures, training records, and other QC-related documentation.
- Perform QC Support tasks – e.g. equipment maintenance, tracking of reagent and sample inventory, organization of the lab, checking to ensure removal of expired media performed, etc.
- Coordinate the timely shipment of samples to contract laboratory for testing (e.g. ship samples such as environmental monitoring plates for growth promotion, speciation and product sample).
- -Other duties may also be assigned
- Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
Education & Experience (Required):
Bachelor’s degree in relevant scientific discipline or other appropriate specialty (such as Chemistry, Life Sciences, Engineering) and one year related experience or an equivalent combination of education and relevant work experience.
Knowledge, Skills and Abilities (Required):
- Applicable or related experience in a laboratory, preferably a clinically related laboratory or demonstrated excellence in laboratory skills and methods.
- Strong technical skills and some experience with testing QC methods and concepts.
- Some knowledge of cGMP or International Organization for Standardization (ISO) requirements, quality systems.
- Strong team-oriented, interpersonal skills and collaborative work style.
- Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
- Excellent organizational skills and attention to detail.
- Excellent verbal and written communication skills.