Quality - Specialist, QA Engineering
Location : 100% Onsite role, Warren NJ
Duration : 8 Months Contract with high possibilities of extension
Work Schedule : Monday - Friday, Business Hours
Must Haves :
- Providing quality oversight on technology transfer
- 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 have strong understanding of global cGMP, quality systems (especially change management), and guidance documents.
- Bachelor's degree required
Position Summary :
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.
Duties / 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 :
EDUCATION AND EXPERIENCE (As Applicable) :
B.S. degree required.Minimum of six years of experience in the pharmaceutical or related industry.Equivalent combination of education and experience acceptable.REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities :
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.WORKING CONDITIONS : (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
