Specialist, QA Engineering
Company: Integrated Resources, Inc.
Posted on: August 7, 2022
Specialist, QA Engineering in Summit, NJ at Integrated
Resources, Inc Job DescriptionJob Description: 1. PURPOSE AND
Product OF POSITION:
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.
2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
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
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 procedures.
Able to fully interpret complex results and situations with 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
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.
Is recognized Subject Matter Expert within the group.
Able to prepare written communications and communicate problems to
management with clarity and accuracy.
Has advanced computer skills to increase 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.
3. DUTIES AND RESPONSIBILITIES
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
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
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 risk
Ensure product risk management documentation/files are maintained,
with good documentation practices and in compliance with Warren
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 to
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
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
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 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
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
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.
4. EDUCATION AND EXPERIENCE (As Applicable)
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 acceptable.
Additional Job Requirements:
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Keywords: Integrated Resources, Inc., New York , Specialist, QA Engineering, Engineering , Summit, New York
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