Description
Review of data & processes that include interpretation and review of product data in the Production Laboratory. Support validation activities related to acquisition of data from various genotyping platforms as needed. Assist with 3rd party and laboratory certification processes as needed. The QC Analyst must possess, and continually develop, an understanding of all platforms and assays currently in the laboratory and in the pipeline and the resulting data generation, interpretation and review.Responsibilities:
- Ensure timely availability, reliability and accuracy of the test data
- Review and approve laboratory data in accordance with standard operating procedures and good documentation practices
- Performs review of data generated from laboratories both internal and external. Discusses the findings of review with peers and management.
- Documents raw data according to SOPs and ISO 17025 requirements from analysis and knowledge of data retrieval and input to/from databases.
- Draws relevant conclusions from data and results and communicates/reports to other analysts, management, and other departments, as applicable.
- Recognizes unexpected outcome/problems; communicates and works independently and collaboratively to solve problems.
- Utilize systems with data acquisition and interpretation software to provide routine data interpretation. Providing second person review of laboratory data in accordance with applicable SOPs.
- Oversee the investigation of quality problems in data generation in order to analyze and propose corrective actions to prevent reoccurrence and to recommend disposition.
- Make recommendations for change and or improvements to documentation and performance of laboratory procedures and operations.
- Audits, reviews, authors and contributes to department and cross-department SOP's and authors new procedures to ensure accuracy and compliance.
- Must be able to communicate and collaborate with various departments (Customer Service, Lab Production, and Quality Assurance (QA), as needed.
- Perform historical QC of data using both manual and automated processes
- Compile and log quality control data and metrics related to data entry, interpretation and results
- Responsible for maintaining and verifying accuracy of test and retest lists.
- Assuring that tests and retests are being assigned and scheduled.
- Compiles Request New lists and delivers to Customer Service.
- Coordinates and directs the activities and functions of validation projects.
- Executes and documents systems validation testing related to data generation, review and reporting
- Other duties and special projects as assigned by management.
Bachelor's degree
- Knowledge of a high-throughput laboratory.
- Ability to implement and effectively manage multiple tasks during a given time frame and to meet strict deadlines for data delivery.
- Strong computer skills, including proficiency with word processing, spreadsheets, and databases.
- Comfortable in a rapidly changing environment.
- Self-motivated; ability to work independently and work as constructive team member
- Standard Operating Procedures (SOP's) desired
- Proficiency with Excel and Access is required