Company: Alpha Consulting
Posted on: May 28, 2023
- 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
- 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
- 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
- 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
- Occasionally, facilitate complex or highly cross-functional
- 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
- ssist 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
- Conduct risk reviews and escalate findings, as appropriate, to
Manager and Warren Leadership with resolution and
- Represent the Risk Management unit at various project meetings
and provide quality input in the resolution of quality-related
- Work independently and perform with a high degree of
- pply 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
- Collaborates with stakeholders to develop appropriate actions
to resolve quality system issues.
- ct 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.
- ssures appropriateness of calibration/maintenance programs,
validation plans, qualification protocols, associated reports and
- 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
- Ensure the site stability program meets global and regulatory
- 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
- Experience in CAR T or Biologics preferred.
- Professional certification in Quality Risk Management
- Equivalent combination of education and experience
- Must have GMP, Quality, and in-depth risk management
- 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
- Must be able to recognize patterns and trends in reported data
and communicate strategic solutions to stakeholders
- 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
- ble to fully interpret complex results and situations with a
degree of independence and articulate recommendations for
- 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
- Represents department in internal and external cross-functional
- 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.
- ble 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
- Understands fundamental scientific problems.
- ble to write and review reports with clarity and brevity.
- ble 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: email@example.com
LPHA'S REQUIREMENT #23-00624
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting, Detroit , Principal Specialist, Other , Warren, Michigan
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