Technology Transfer Scientist II Job Rochester area,New York USA,Quality Assurance

Title:
Technology Transfer Scientist II
Location:
Rochester, NY
Duration: 6 months
Pay Range: $40 - $45/hr. on w2

Job Description :

30% Operate within established Change Management, Verification, and Validation procedures to ensure compliance and maintain high-quality standards. Contribute to the creation and maintenance of operations documentation, including FMEAs, validation plans, protocols, reports, SOPs, and related materials. 30% Implement new and improved processes for Quality Operations Value Assignment teams, including integrating updates to software tools enhancing efficiency and accuracy.
15% Assess product designs for alignment with Operations requirements, providing feedback to design teams to mitigate risks early to drive optimization of business and operational processes
15% Collaborate closely with R&D and technical partners to ensure thorough knowledge transfer, enabling smooth transition from development to Operations. Lead and/or support training initiatives to ensure teams are equipped with the knowledge and skills required for new processes, tools, or product introductions
10% Support overall program execution by helping teams meet key milestones and ensuring alignment with project timelines by coordinating activities across cross-functional groups, proactively identify and resolve issues to maintain project momentum.

Education:
Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 3 years’ experience in an Tech Transfer, Operations or Product Development/Support role within a GMP manufacturing environment.

Experience required:

Minimum of 3 years’ experience in an Tech Transfer, Operational or Product
Development/Support role within a GMP manufacturing environment.
Demonstrated ability to successfully deliver against project timelines
Track record of contributing to cross-functional teams within a regulated environment.
Knowledge of R&D and Operations (manufacturing, quality processes and systems) is required.
Ability to recommend efficient solutions to harmonize potential process changes with operational preferences.
Efficient use of common applications, such as MS Excel, is required.
cGMP and external audit experience (GMED, FDA, etc.) is strongly preferred.
Maintains an organized approach – understands priorities and escalates issues appropriately.
Knowledge of client products and quality system is preferred.
Multi-disciplined validation experience is strongly preferred (Process, Product, Method).
Experience with Lean Manufacturing, Six Sigma and Mistake Proofing is preferred.

#sczr2