Quality Control Analytical Scientist

Qualifications

• Bachelor's degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.
• Minimum of 3 years of analytical development or validation experience in GMP Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Excellent technical writing skills and ability to write technical documents and reports that meet company and regulatory requirements.
• In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.
• Knowledge about analytical method validation and critical reagent qualification.
• Intermediate statistical knowledge and experience with data analysis.
• Knowledge concerning cGMP, especially lab related topics such as method validation and 2 unexpected results investigation.
• Basic knowledge about regulatory requirements concerning analytical instrumentation, test methods and licenses.
• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.
• Able to complete tasks with minimal direction, demonstrate basic project management skills.
• Able to multi-task in a highly dynamic and diverse environment.
• Attention to detail, good organization, and time management skills to meet deadlines.
• Proficient in Microsoft Office.
• Strategic and business-oriented thinking.

Responsibilities

• Support various Quality Control activities within the AQC department.
• Transfer and execute analytical methods, including raw materials, for use in a CGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).
• Drive special projects that require AQC attention/leadership.
• Drive analytical method development and validation of laboratory methodologies and instrumentation. This includes leading analytical/microbiology QC efforts to support the introduction of new product testing, modifying existing laboratory space, plan design new laboratory spaces and working with vendors to purchase new instruments, and the installation and qualification of new instruments.
• Serve on project teams, in a leadership role as needed, which will require substantial interaction and communication with other group functions.
• Upgrade of analytical technologies within an established licensed technology platform.
• Support investigations and manufacturing investigations requiring analytical method support.
• Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.
• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols.
• Support troubleshooting of analytical methods and instruments and support laboratory investigations as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations.
• Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.
• Ensure all laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.
• Responsible for protocol and report generation as well as authoring CMC submission and other technical documents as required. This includes supporting raw material qualification for new products.
• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.
• Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry.
• Use sound scientific principles and statistical techniques to solve problems and make recommendations.
• Responsible for deliverables to ensure timelines and milestones are met.
• Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).
• Lead small teams as needed to accomplish tasks.
• Representative for Analytical projects with global and local site functions. Ensure RightFirst Time (RFT) in the method introduction and instrument qualification process.
• Other duties as assigned.