RLT Remediation QC Specialist in Millburn, NJ

RLT Remediation QC Specialist

Onsite role in Millburn, NJ

• Reporting to the AAA Site Remediation Lead, the AAA Remediation QC Specialist is responsible for the on-time execution of Remediation Project Plan deliverables related to Quality Control, ensuring successful completion of remediation commitments and successful inspection outcomes.
• There will be a strong focus on equipment validation, compliance, record backlog elimination, and sterility assurance.
• This is a high visibility and demanding role, bringing with it the opportunity to learn about the company, shape global healthcare trends and have impact at the highest level.

Major accountabilities:

Responsibilities include but not are limited to:

• Execute and/or review deliverables for the Site Remediation Project Plan, enabling overall strategic implementation of remediation activities according to the site’s commitments to Health Authorities.
• Remediation activities are related to facility, equipment, quality systems, computerized systems, laboratory or products.
• Work in close collaboration with site-based SMEs to ensure the implementation of robust, high-quality deliverables, with clear alignment between inspection SMEs and site leadership.
• Certified investigator for deviations and OOS; drive and/or review deviations and lead strategic discussion for investigations with respect to Quality Control related matters in support of record backlog reduction.
• Responsible for the design and implementation of corrective and preventative actions.
• ?Authors SOPs, work plans, method transfer/qualification/validation protocols, and reports according to Client Global Standards
• Define and plan agendas, deliver content and/or lead preparation for project governance meetings, as delegated by the Site Remediation Lead
• Responsible for routine reporting of the status of deliverables and risk to the Site Remediation Lead and delivering relevant content for governance meetings
• Reinforce the site’s Inspection Readiness program for regulatory inspections, Client baseline audits /audits and providing hands-on support at sites in preparing for inspections / audits
• Actively drive high quality deliverables at the site by promoting a high standard of Quality Culture. Helps build and drive a culture of compliance throughout the organization
• Inspire change management initiatives, control project scope to limit schedule changes, and capture changes of scope that may arise
• Partner with Site QC to ensure the Primary SME is trained and ready to deliver remediation evidence during regulatory inspections; final project handover, including Remediation Continuity Plan as needed

Key performance indicators: 

• Successful and timely completion of the site’s Remediation Plan deliverables, meeting strategic objectives of AAA Global Remediation Task Force
• Successful Health Authority Inspections

Job Dimensions:

Number of associates:

• N/A; indirect coordination with AAA Global Remediation Task Force and multiple cross-functional stakeholders

Financial responsibility:

(Budget, cost, sales, etc.)

• Adhere to established budget and costs

Impact on the organization:

• High; significantly contributes to success of AAA RLT objectives by ensuring cGMP-Compliance with focus on Successful Health Authority Inspections & correct, cGMP compliant decisions as part of critical Quality Issues (e.g. market actions).

Ideal Background:

• B.S. degree in Science, Engineering or related field with 5 years’ relevant experience or MSc with 3 years of relevant experience.
• Experience in quality-based roles including experience in cGMP and/or laboratory operations required
• Must have a working knowledge of FDA and global regulatory requirements as well as industry quality management tools, standards, and quality systems.
• Must understand pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
• Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections
• Good understanding of local/National Health Authorities regulations and Client standards
• Excellent technical writing skills
• Demonstrated ability to problem solve and mediate complex issues. Project management capabilities preferred.
• Strong communication, leadership and team working skills
• Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance)
• Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization – oral and written
• Demonstrated ability to work cross-functionally
• Highly motivated, driven and have a passion to be part of a fast-paced team

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