Latitude, Inc. Quality Control Specialist (Scientist) in Baltimore, Maryland
Evaluates and implements protocols and methods to inspect and test in-process materials and finished products and ensures compliance with internal and external safety, quality and regulatory standards requirements for distribution. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk materials and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection/testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records. Assures compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
Leads QC testing of in-process, release and stability samples for the Baltimore location
Works to maintain and continuously improve QC laboratory controls.
Analyzes and formats data to support method evaluation and trending.
Performs analytical data review to ensure data integrity and adherence to standard operating procedures and CGMPs.
Serves as a resource of technical knowledge for established assays during audits / inspections and with internal / external customers or clients.
Leads design of analytical method validations and executes validation studies including test method transfer activities to and from EMOB.
Provides technical expertise for method development, optimization, verification, qualification and validation.
Serves as the QC lead for planning and coordinating execution of method transfer, development, optimization, verification, and validation including along with writing protocols and reports, as needed. This includes ordering of supplies and materials, documents preparation, providing training, working with other sites and collaborators.
Leads laboratory investigations and provides oversight to the content of investigation reports. Leads CAPAs and change controls as necessary.
Applies expertise to support change and risk management, including application of scientific and technical innovation.
Actively participates in equipment and instrument purchase, qualification, calibration, and preventive maintenance, as assigned.
Maintains good working relationships with organizations that are transferring processes to Bayview.
Assists in evaluating new technologies or new applications of established technologies that lead to improved product quality and lower costs.
Interacts with other functions on a technical level for various projects.
Provides input to troubleshoot manufacturing complications in collaboration with Analytical Sciences, Manufacturing Sciences, Operations, and the PAD groups at other sites.
Implements control systems to meet cGMP/GLP requirements where required including 21CFR Part 11 compliance.
Communicates, supports, and meets corporate and site goals and objectives
Prepares presentations for senior management to provide updates and facilitate decision-making.
Builds and maintains strong relationships with site leads, corporate management and staff to ensure effective communication.
Bachelor?s degree in Biology, Biochemistry, Chemistry or closely related scientific discipline with 5-7 years of relevant experience or MS with a minimum of 3 years of relevant experience.
A minimum of 5 years in a FDA regulated environment, with 3-5 years of experience with electronic document management, deviations (i.e. non-conformance), CAPA and change control systems.
Skilled in technical writing, critical thinking and fact-based decision-making.
Must possess strong knowledge of and experience with HPLC, GC, cell culture and cell-based assays such as TCID50 and plaque assays. Skills and knowledge in immunological and ligand-based test methods such as ELISA, Western Blot and SDS-PAGE testing is also desirable.
Skills and knowledge of general chemical and bioanalytical test methods such as pH, Appearance, UV spectroscopy, Karl Fischer, Moisture Determination, Particle Size, Container-Closure Integrity, CE, Gel electrophoresis, IEF and qPCR.
Advanced knowledge of cGMPs, safety and data integrity as relevant to a QC laboratory.
Experience in executing phase appropriate method qualifications and validations.
Knowledge of viral based delivery systems and the methods used to analyze them is highly desirable.
Excellent written and verbal communication skills including ability to write reports for method verification/qualification/validation.
Computer skills (MS Office)
Experience with statistical software applications (i.e. JMP) is desired.
Experience with LIMS and SAP software applications is desired.