Principal Quality Assurance Process Design Specialist

Multiple Locations: Texas, United States • North Carolina, United States • Arizona, United States • Georgia, United States • South Carolina, United States

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Requisition Number: 588

Position Title: QA Process Design Specialist

External Description:

SUMMARY:                       The QA Process Expert is an experienced GxP workflow and process design expert with a desire to work collaboratively across Worldwide to design and produce clear, concise and effective Quality Documents and drive improvements in the effectiveness and efficiency of Worldwide document management processes.

The QA Process Design Specialist will foster a culture of continuous improvement, readily participate in cross-functional initiatives and collaborate with colleagues across the organization. This individual will work collaboratively with Subject Matter Experts and process owners to guide the design of workflows and processes and write clear concise Policies, Standard Operating Procedure, and other related GCP/GLP/GVP documents in support of the Quality Manual.

 

RESPONSIBILITIES:

Tasks may include but are not limited to:

Strategic Thinking

  • Identify areas for improvement within QMS and/or QMD processes, create and execute plans for improvement
  • Thinks creatively about strategies to engage employees and ensure visibility, access, and clarity of quality procedures.
  • Champions and drives change throughout the organization.
  • Design collaborative review process to improve efficiency and effectiveness

Design, Writing, and Editing

  • Works collaboratively with Subject Matter Experts and process owners to design workflow and write clear concise Policies, Standard Operating Procedure, and other related GCP/GLP/GVP documents in support of the Quality Manual
  • Perform Collaborative review as Quality Assurance representatives
  • Contribute and support the creation of QMDs across the organization.
  • Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively and proactively works to resolve conflicts in content or design
  • Translates process maps or other process representations and transforms them to SOP procedures or supporting materials.
  • Works with functional area SMEs to develop cross-functional process models

QMD Training

  • Collaborates with Training Department and subject matter experts to determine the most effective training strategy for new or revised quality documents.
  • Contributes to designing and delivering training content and materials for procedures and related materials.
  • Creates and delivers training for SMEs and Process Owners on process mapping, workflow design and procedure writing.
  • Takes and educational approach working with SMEs and process owners to lead and educate on workflow design process and effective procedures.
  • Designs training and communication related to QMD procedures in collaboration with Training Management.
  • Contribute to the design and delivery of new employee QA orientation and quality system refresher training.
  • May contribute to designing/updating/evaluating additional training materials or programs.

Continuous Improvement

  • Contribute to establishing standards for QMD compliance, including format requirements, minimum content, and regulatory references.
  • Contributes to the development and maintenance of up-to-date SOP writing procedures so that the process is used and consistently applied by all process writers and authors
  • Collaborate with cross-functional partners to Identify gaps in current procedures and systems and leading an effort to gain remediation/closure, including ensuring current US and international regulations, laws, and guidelines and reflected in QMDs.
  • Contributes to solutions to improve visibility, communication, and navigation of procedures across Worldwide.

Customer Service

  • Fosters a culture of exemplary customer service within QA and demonstrates this in proactive communication, driving improvements, identifying solutions, and peer collaborations.
  • Solicits regular feedback from the organization to ensure procedures are meeting the needs of the business. Identifies areas for improvement and readily makes changes to improve.
  • Creates communication across the organization to ensure all areas are sufficiently informed of QMD releases, changes and requirements.

Contribute as a Document Control team member

  • Contributes to the maintenance and updates to the SOP harmonization tracking spreadsheets and timelines, as assigned
  • Review and manage deviations as needed per the QMD deviation management procedures.
  • Works collaboratively and proactively as a team member and supports team members to achieve overall objectives.
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 

OTHER SKILLS AND ABILITIES:

  • Proven experience designing workflows and writing standard operating procedures and job aids
  • Experience designing and delivering training content within GxP
  • Experience leading complex cross-functional projects
  • Experience with Document Management Systems a plus
  • Demonstrated success in managing quality systems such as deviations, change orders, etc.
  • Knowledge and experience with how to identify key quality metrics for maintaining compliance and identifying areas of improvement
  • A high degree of initiative, decision making, and responsibility which will enable the incumbent to perform efficiently with minimum supervision.
  • Ability to effectively prioritize and manage multiple projects and tasks
  • A team player builds productive working relationships, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner and able to express ideas in a written and oral context
  • Possess a flexible approach to problem-solving, be an adept negotiator and apply risk-based decisions
  • The ability to adapt to working effectively within a variety of situations; adapts to organizational change and to changes in job demands.
  • Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

 

REQUIREMENTS:

  • Four-year college curriculum with concentration in nursing, biological, physical, health, pharmacy or other related science
  • A minimum of 10 years of QA GCP experience in biotech/pharmaceutical environment
  • Strong understanding of domestic and international regulatory requirements
  • Preferred, experience in assisting audits and/or inspections by regulatory agencies
  • Proven experience developing and implement GxP quality systems
  • GcLP, GLP, GVP, GPP and GMP knowledge an asset
  • Ability to speak, read and write English fluently
  • Domestic and international travel required (approximately 15%)

 

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Principal Quality Assurance Process Design Specialist

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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