Validation Lead

Sumeru Solutions

Job Location:

Santa Monica, CA - USA

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Knowledge

Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Experience in deviation and CAPA management impact assessments and root cause investigations.
Strong technical writing reporting and documentation review skills.
Effective verbal communication interpersonal and stakeholder management skills.
Proficient in Microsoft Office applications.

Responsibilities

Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Provide front line QA support to escalations ensuring timely actions and clear resolution paths.
Contribute to the Quality on the floor processes including shopfloor rounds and real time QA support.
Performs QA review and approval of deviations and corrective and preventive action (CAPA).
Conducts or acts as a coordinator of investigations and CAPA recommendations related to manufactured products
Identifies and reports deviations from approved processes and procedures to senior colleagues.
Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met
Exercises judgment within well-defined established procedures and practices to determine appropriate action identifies problems and generates alternatives and recommendations within defined processes.
Works directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May act as mentor to junior staff with some task management responsibility.
Contributes to QA projects and participates in cross-functional teams.
Coordinates planning organization and implementation of projects within specified objectives.
Works on more complex non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
Additional duties as assigned

Knowledge Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Experience in deviation and CAPA management impact assessments and root cause investigations. Strong technical writing reporting and documentation review skills. Effective verbal commu...

Knowledge

Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
Experience in deviation and CAPA management impact assessments and root cause investigations.
Strong technical writing reporting and documentation review skills.
Effective verbal communication interpersonal and stakeholder management skills.
Proficient in Microsoft Office applications.

Responsibilities

Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and Kite procedures.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Provide front line QA support to escalations ensuring timely actions and clear resolution paths.
Contribute to the Quality on the floor processes including shopfloor rounds and real time QA support.
Performs QA review and approval of deviations and corrective and preventive action (CAPA).
Conducts or acts as a coordinator of investigations and CAPA recommendations related to manufactured products
Identifies and reports deviations from approved processes and procedures to senior colleagues.
Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met
Exercises judgment within well-defined established procedures and practices to determine appropriate action identifies problems and generates alternatives and recommendations within defined processes.
Works directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May act as mentor to junior staff with some task management responsibility.
Contributes to QA projects and participates in cross-functional teams.
Coordinates planning organization and implementation of projects within specified objectives.
Works on more complex non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
Additional duties as assigned