Senior Analyst

Primary duties of this position will include serving as a lead for various technical aspects of the QC areas. Position will provide both subject matter expertise as well as technical leadership on activities such as method related projects (ex. method transfers and validations), investigations, quality events, data analysis and trending, key program oversight (ex. reference standard program), and cross-functional interaction on various teams to enable appropriate overall QC support on projects and programs, as well as external coordination to contract organizations. Position will also assist in managing departmental and/or cross-functional teams occasionally.

Discretion/Latitude:

· Works autonomously and receives general instructions on new assignments.

· Proposes technical strategies and frequently discusses soundness of technical judgment and reviews progress in meeting objectives and timelines with supervisor.

· Operates under compliance requirements. May independently refer to or seek guidance on policies and practices.

Impact:

· Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization.

· Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities method remediation and troubleshooting, method monitoring), critical reagents and reference standard programs, global technical oversight program, cell bank adventitious agent safety testing.

· Method monitoring and data analyses.

· Pharma/Biotech Background.

· Statistics experience.

· At least 2 Year Experience Preferred.

· Senior specialist who can focus on Non-laboratory activities.

· Candidates need to have very good experience with monitoring activities.

· Data analyses, data trending, statistical analyses, asset controls.

· Looked at methods from statistical perspectives.

· Experience writing SOP’s.

· Experience working with reference standards.

· Method Validations-Monitoring.

· If they are already working in the lab the HM will consider them as well.

With Regards,

Kavita Kumari

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 – 2007-2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Tel: 732-549-2030 x208

Fax: 732-549-5549

Direct: 732-549-5302

www.irionline.com

https://www.linkedin.com/in/rkavita