Quality Control Analytical Scientist

Quality Control Analytical ScientistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The QC Analytical Scientist will be a member of the Quality Control Department. As a Senior Member of the team the QC Analytical Scientist will be involved in various QC projects and should have a deep understanding of general QC flow and the Product Cycle.

• Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients.
• Support routine GMP testing as assigned. Mentor and train team members
• Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements.
• Write the contents of Analytical Method Transfer and Validation life cycle documentation including master plans, protocols, test methods, and reports.
• Create validation project plan i.e., timelines and resources and provides status updates to management. Utilize statistical tools for evaluation of method validation and trending data.
• Identify, evaluate, and implement continuous business process improvements.
• Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS).
• Provide support during laboratory investigations.
• Train QC personnel during method transfer and validation. Provide support during equipment qualification.
• Consistently produce elevated level of documentation accuracy and clarity according to cGMP documentation practices.
• Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures.
• Indirectly may supervise cross functional teams including product development, QA, PMP, and Manufacturing.

REQUIREMENT

• B.S Analytical Chemistry or other scientific field or MS/Ph.D. in Analytical Chemistry or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products.
• 8-10 years of experience in the areas of method development, validation, and transfer.
• Direct GMP Experience.
• Proficiency in project management skills and tools.
• Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc.
• Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs.
• Strong Quality orientation with attention to detail required. Analytical and problem-solving skills required.
• Excellent communication skills, both written and verbal, with all levels of the organization, including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
• Excellent presentation skills. Ability to communicate to upper management, across departments and within the immediate QC team.
• Ability to create and manage work plans and timelines and independently manage competing priorities with limited instruction.
• Highly motivated individual with good interpersonal skills that have proven effective in managing relationships and negotiating solutions while maintaining a level of approachability with colleagues both internal and external.
• Must be familiar with GMP lab environment and Aseptic techniques.

Working EnvironmentMust have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays, or overtime and as required by the companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogenMust have the ability to work with specialized equipmentMust be able to handle the standard/moderate noise of the manufacturing facilityMay work with hazardous materials and chemicals Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.