Associate Manager, Quality Assurance

Description

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development with a focus on cGMP 1994 we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies 2004 we opened our peptide production facility in Menlo Park CA and in 2014 we expanded our production capability through the addition of a new state of the art building dedicated to cGMP peptide 2017 we passed a FDA inspection and were recommended to be approved for commercial drug substance 2023 we added additional cGMP clinical production capacity in Milpitas CA.

Job Duties :

• Support Quality Management System at CSBio encompassing quality investigations including Deviations CAPAs and oversee Document Control Training and Customer Complaints.
• Provide direction assess and remediate as appropriate current and previous validation documentation including conducting gap assessments risk assessments and development of standards.
• Review / approve OOS deviations CAPAs SOPs and operation documents.
• Create and provide guidance on phase-appropriate processes and systems.
• Review Risk Assessments Process Development Reports and Protocols.
• Quality support of the validation system to ensure quality and compliance requirements are met in an efficient and effective manner.
• Quality support and approval of validation related documentation (e.g. IQ OQ PQ etc.); this includes process facilities utilities equipment test methods cleaning and software validations.
• Work with Operations Manufacturing Quality Control and Validation to maintain a validation assessment plan for all GXP assets buildings systems including laboratory instrumentation and systems.
• Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues.
• Support the recall process including initiation customer and regulatory notification and product withdrawal.
• Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes.
• Manage develop and mentor staff.

Competencies :

Requirements

Benefits

Required Experience :

Manager

Key Skills

Administrative Skills,Core Java,Glass,Administration Support,Database Administration,Import & Export

Employment Type : Full-Time

Experience : years

Vacancy : 1