What are the responsibilities and job description for the Specialist, QA Engineering: Tech Transfer position at Artech LLC?
Title : Specialist, QA Engineering
Duration : 08 months
Location : Warren NJ (100% Onsite role)
Payrate : $64 / hr
Work Schedule : Monday - Friday, Business Hours
Screening Questions :
Here are the screening questions :
1) Do you have experience with GMP manufacturing of CAR-T / Biologics / anything else?
2) Any experience with technology transfers (for process) and new product introduction?
3) Have you worked with Change Controls before? If yes, on what role : Owner / Impact Assessor / QA / anything else?
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
EDUCATION AND EXPERIENCE (As Applicable)
REQUIRED COMPETENCIES : Knowledge, Skills, and Abilities
Salary : $64
