Beschreibung
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an QA Lab Oversight Specialist !
The QA Lab Oversight role is an exempt level position with responsibilities for providing quality oversight for Raritan site Quality Control laboratories. The responsibility includes reviewing and approving, of standard operating procedures (SOPs)/ Forms, validation/ qualification/ method transfer protocols/ reports, completed assay data for testing of pre-clinical, clinical, and commercial stage CAR-T cellular therapy products tested in QC labs which includes In Process, Release, Critical Reagents and Microbiology labs, Monthly Lab audits, initial approval for retest for SST/AAC/ SAC failures. Closure of QIs related to SST/AAC/ SAC.
Role Objective
Works in a collaborative team setting with diverse personnel that include all Quality Control Departments including QC Critical Reagents, QC Release, QC IPL, QC Micro and QC Lab Services to provide daily QA assistance.
Major Responsibilities
- Provides quality oversight for site Quality Control laboratories responsible for testing clinical and commercial stage CAR-T cellular therapy products in accordance with J&J policies, standards, procedures, and Global cGMP.
- Work with QC organization to support the successful transfer of QC Lab functions to the Raritan cGMP facility to test products.
- Review and approve Technical Documents, Completed Daily Assay Data, Personnel Gowning and Pipette Qualifications, Data Generated Reports and CoA's as applicable.
- Support the release of patient sample materials.
- Provide Quality feedback to QC Management by performing spot-checks in the QC Laboratories to ensure compliance.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
- Strengthen QC Culture and recognize patterns/trends in Shop floor behaviour, reported data and communicate to management trending issues for improvement opportunities.
- Provide mentorship to other employees in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seeks management perspective on quality issues.
- Interpret sophisticated results and situations with degree of independence and articulates recommendations for solutions. Identifies risk and develops contingency plans.
- Act as liaison for the quality team to guide and improve site improvement projects and strategies.
- Learn and develop within the business as a Subject Matter Expert on quality assurance topics.
- Detailed knowledge of CAR-T QC test methods and related equipment is helpful.
Befähigungen
A Bachelor’s Degree in Science or equivalent experience.
Experience and Skills
2-4 years relevant work experience is required. It is preferable that the candidate has experience in cGMP aseptic manufacturing environments, preferably in quality control, quality assurance, manufacturing, compliance, clinical quality, or cell and gene therapy.
- Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process information and make critical decisions with minimal oversight.
- Proficient in applying process excellence tools and methodologies.
- Ability to independently be responsible for a portfolio of ongoing projects.
- Ability to pay attention to details and follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive approach under some supervision.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Ability to work with others in a team environment.
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP). Knowledge of current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing is a plus.
- Ability to identify/remediate gaps in processes or systems.
- Experience with cell and/or gene therapy analytical technique (e.g. flow cytometry, qPCR)
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
Additional Information:
- The anticipated base pay range for this position is $58,000 to $80,500 annually .
- This position is overtime eligible
- Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .