PRINCIPAL SPECIALIST WARREN, NJ Project Description:
The Principal Specialist is responsible for supporting Warren Cell Therapy Quality Risk Management Program and providing quality oversight for Site Technology Transfer activities and Validation activities in accordance with Client policies, standards, procedures and Global cGMP in a fast-paced, highly collaborative clinical manufacturing facility producing cell therapy CAR T and engineered T Cell products for first-in-human and early phase trials.
Functional responsibilities for the incumbent include facilitating risk assessments to identify risk areas and risk mitigation measures, ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities; ensuring accurate and timely review of technology transfer documents; ensuring accurate and timely review of investigations and evaluation of change controls.
Supports all activities for the QA Engineering group.
Support cross functional departments on risk identification, root cause analysis and investigative measures and support evaluation and implementation of a plan to mitigate process and/or product risks.
Contribute to the writing, coordination, review, approval, and maintenance of the Warren Risk Management Standard Operating Procedures (SOPs) and associated documentation.
Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
Develops and Maintains Quality Metrics to monitor compliance.
Evaluate and report key performance metrics, analyze data, and lead improvement initiatives.
Support risk owners in planning, execution, and completion of risk assessments by providing direction, and guidance to cross functional teams.
Occasionally, facilitate complex or highly cross-functional risk assessments.
Ensure product risk management documentation/files are maintained, with good documentation practices and in compliance with Warren Quality System.
Partner with other risk management stakeholders, including Validation, Manufacturing, Quality Control, Patient Scheduling, Facilities, Warehouse and Safety.
Drive continuous improvement for effective risk management and address recurring issues identified throughout Warren.
Track and verify appropriate corrective actions have been implemented, documented, and align with source event.
Maintain Warren Quality Risk Catalog, Risk Register Registry and track the status of risk mitigation actions through to completion.
Assist the risk owner to schedule and facilitate Warren risk assessment activities to identify risk areas and implement risk mitigation measures to support manufacturing, compliance and business continuity.
Conduct risk reviews and escalate findings, as appropriate, to Manager and Warren Leadership with resolution and recommendations.
Represent the Risk Management unit at various project meetings and provide quality input in the resolution of quality-related issues.
Work independently and perform with a high degree of accuracy.
Apply Federal (FDA) Good Manufacturing Practice (GMP) requirements, guidelines, and documentation practices.
Proactively learn, develop, and customize methods and techniques (e.G., Six Sigma/Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
Provide subject-matter expertise and consultation to risk assessment teams at the site.
Develop and deliver training on QRM concepts, methods, and regulatory expectations.
Collaborates with stakeholders to develop appropriate actions to resolve quality system issues.
Act as primary link to other CTDO sites to ensure Quality systems are properly implemented and consistent.
Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
Review media simulation activities to ensure successful execution and documentation.
Ensure site is compliant with global and regulatory data governance and data integrity requirements.
Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
Ensure procedures are adequate to review and confirm appropriateness of laboratory raw data.
Review/approval of technology transfer related deviations/discrepancies.
Ensure the site stability program meets global and regulatory requirements.
Ensure process and method transfers, method qualifications/verifications, and analyst trainings meet company and regulatory requirements.
B.S. Degree required.
Minimum of seven years of experience in the pharmaceutical or related industry.
Experience in CAR T or Biologics preferred.
Professional certification in Quality Risk Management preferred.
Equivalent combination of education and experience acceptable.
Must have GMP, Quality, and in-depth risk management knowledge.
Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
Routinely recognizes and resolves Quality issues; informs management of proposed solutions.
Seeks management guidance on complex issues; develops procedures.
Able to fully interpret complex results and situations with a degree of independence and articulate recommendations for solutions.
Recognizes risk and develops contingency plans.
Negotiates solutions cross-functionally.
Drives continuous improvement and improves efficiency and productivity within the group or project.
Effectively communicates internally within the function and with internal and external cross-functional teams.
Interacts with internal and external cross-functional teams.
Represents department in internal and external cross-functional teams.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Consults management for advice on complex issues.
Work is self-directed.
Able to prepare written communications and communicate problems to management with clarity and accuracy.
Has advanced computer skills to increase the department's productivity, as well as broadening technical and scientific knowledge.
Understands fundamental scientific problems.
Able to write and review reports with clarity and brevity.
Able to produce data reports with precision.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-00624
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE