Quality Control Engineer II - RST
Quality Control Engineer II - RST
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Job Description
The Quality Control Engineer II is responsible for performing quality control assays including release in-process and stability tests performing environmental monitoring within the clean rooms and leading assay development and validation tasks as directed by supervisor providing qualification and validation support for manufacturing processes that are essential to the clinical production.
Perform all GMP related activities strictly according to SOPs with accurate and complete documentation associated with the testing in compliance with cGMP principles of Data Integrity and good documentation practices. Perform investigations and process improvements including CAPAs and Change Controls. Ensures compliance with all applicable Federal and State accrediting agency requirements in the testing of biopharmaceutical products manufactured in the current Good Manufacturing Practices (cGMP) facility. Participate in identifying optimizing and validating new analytical procedures for testing as necessary. Assists in reviewing and revising Standard Operating Procedures as necessary. Perform general laboratory activities as assigned by supervisor. Complete and maintain updated all training required to perform assigned tasks and trains others where qualified. Reviews data and supports internal and external audits.
Qualifications
- A bachelors degree in a biomedical related field and a minimum of 2 years relevant experience within a laboratory or Masters degree in a biomedical related field.
- A technical understanding and experience performing analytical molecular or microbiological assays.
- Ability to analyze data and compose reports.
- Effective human relations and communication (written verbal and listening) skills are required.
- Must be flexible and capable of adapting to and facilitating change.
- Must have demonstrated capacity to comprehend complex protocols programs and situations.
- The ability to exercise good judgment while working under deadlines is required.
Must be flexible with work schedule as needed to meet internal and external customer needs.
Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.
Employment Type
Full-Time
