QA Investigation Auditor

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: QA Investigation Auditor

Location: Warran, NJ

Duration: 8 months

Pay rate: $55 to $62 W2 Deal

Job Description:

This role is responsible for providing quality oversight on technology transfer into and out of the site, process understanding and enhancement, and other site qualification activities in a fast-paced, highly collaborative manufacturing facility. This team supports the Cell Therapy Development early clinical drug product manufacturing facility, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.

Roles And Responsibilities:

• QA lead on technology transfer activities (process):
• Ensure technology transfers on new product introduction and/or new trials and cohorts are compliant with internal standards and/or regulatory requirements, as applicable.
• Maintain knowledge of scientific literature, regulatory guidelines, internal standards/procedures and apply key concepts during project activities/plans.
• Interact and coordinate with other QA functional teams to ensure timely completion of QA related activities.
• Interact and collaborate with cross-functional teams to achieve common goals.
• Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
• Must be knowledgeable on change control process.
• Must be knowledgeable on the process and associated methods for the assigned product.
• Support Product/Program Lifecycle Management Activities
• Support change initiatives and implementation of new technologies, process and method improvements, material changes and ensure compliance with internal standards and regulatory requirements.
• Support regulatory filings and amendments, as applicable (i.e. IND, INDa, CTA etc.)
• Participate and drive Quality Risk Management (QRM) initiatives at the site to ensure risk areas are identified and risk control measures are implemented.
• Review media simulation activities to ensure successful execution and documentation.
• Maintain data integrity by ensuring procedures/processes are compliant with internal data integrity standards and procedures.
• Work with Engineering/Facilities/Warehouse/Supply Chain/Manufacturing Operations/Quality Control management to ensure functional activities comply with internal standards and regulatory requirements.
• Ensure procedures are adequate to review and confirm appropriateness of data.
• Display Leadership Qualities
• Create an environment of teamwork, open communication, and a sense of urgency
• Promote a mindset of continuous improvement, problem solving, and prevention
• Drive strong collaboration within the site and across the network
• Build trust and effective relationships with peers and stakeholders
• Drive improvements to remove inefficiencies, improve quality and optimize productivity.
• Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
• Reporting Relationship
• Reports to Senior Manager, QA Engineering
• Qualifications
• B.S. degree required.
• Minimum of six years of experience in the pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.
• Must have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
• Must have knowledge of technology transfer for manufacturing processes.
• Must routinely anticipate, recognize and resolve quality issues with minimal direction from management. Inform management of proposed solutions on complex issues.
• Must be able to get resources and information from established internal contacts; consult with supervisor for decisions outside established processes.
• 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 fully interpret complex results and situations independently and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally.
• Must be action-oriented, customer-focused, skilled in decision-making, build relationships, good at problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Work is self-directed.
• Must effectively communicate and interact with management and stakeholders with clarity and accuracy.
• Understands fundamental scientific problems.
• Must have strong quality background.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.