What are the responsibilities and job description for the Sr. QA Engineer- Technology Transfer– Pharma (Onsite, Warren, NJ) position at Stage 4 Solutions Inc?
Sr. QA Engineer- Technology Transfer Pharma (Onsite, Warren, NJ)
We are looking for a Sr. QA Engineer- Technology Transfer Pharma for a global pharmaceutical company. 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 is a 40-hour per-week, 8-month contract (extensions possible), 100% onsite role in Warren, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities :
- 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.
- Provide training to QA colleagues on new product manufacturing process, as applicable to ensure clinical production readiness.
- 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.
- Develop and author training and other documents to educate and to improve consistency, quality, and efficiency in performing routine activities.
Requirements :
Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the Sr. QA Engineer- Technology Transfer Pharma (Onsite, Warren, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation : $60 / hr - $64 / hr
LI-SW1
Salary : $60 - $64
