SBM Management Services, LP
QA Document Control Associate
SBM Management Services, LP, Tustin, California, United States, 92681
Overview
The QA Document Control Associate supports departmental operations by assisting customers with document revision and internal/external document requests. Location:
Irvine, CA Responsibilities Support departmental operations by assisting customers with document revisions and internal/external document requests. Collaborate cross-functionally to ensure timely and effective execution of document review activities. Proficiency with the ComplianceWire electronic training system, including tasks such as assigning curricula, generating training reports, and creating or revising curricula. Issue and reconcile equipment logbooks, laboratory notebooks, and controlled documents (e.g., SOPs, forms, and logs). Maintain and organize documents within the QA archive; retrieve archived documents upon request. Uphold GMP standards and QA policies, including adherence to Good Documentation Practices (GDP). Assist in maintaining inspection readiness and provide support during regulatory and other audits. Perform additional duties as assigned by Quality Management.
Education and Experience
B.A. or B.S. degree (preferably in Life Science). Minimum of 1-3 years of experience in the biopharmaceutical industry.
Certificates, Licenses, Registrations
May be required to have a valid drivers license. Complete all safety and task training
Knowledge, Skills, and Abilities
Knowledge of CGMPs or equivalent regulations. Ability to interpret quality standards for implementation. Skills to independently evaluate situations and propose potential solutions.
Compensation
$32.00 - $33.00/hour Shifts
9-6 pm Monday-Friday Equal Opportunity Employer
SBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status. Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Facilities Services
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The QA Document Control Associate supports departmental operations by assisting customers with document revision and internal/external document requests. Location:
Irvine, CA Responsibilities Support departmental operations by assisting customers with document revisions and internal/external document requests. Collaborate cross-functionally to ensure timely and effective execution of document review activities. Proficiency with the ComplianceWire electronic training system, including tasks such as assigning curricula, generating training reports, and creating or revising curricula. Issue and reconcile equipment logbooks, laboratory notebooks, and controlled documents (e.g., SOPs, forms, and logs). Maintain and organize documents within the QA archive; retrieve archived documents upon request. Uphold GMP standards and QA policies, including adherence to Good Documentation Practices (GDP). Assist in maintaining inspection readiness and provide support during regulatory and other audits. Perform additional duties as assigned by Quality Management.
Education and Experience
B.A. or B.S. degree (preferably in Life Science). Minimum of 1-3 years of experience in the biopharmaceutical industry.
Certificates, Licenses, Registrations
May be required to have a valid drivers license. Complete all safety and task training
Knowledge, Skills, and Abilities
Knowledge of CGMPs or equivalent regulations. Ability to interpret quality standards for implementation. Skills to independently evaluate situations and propose potential solutions.
Compensation
$32.00 - $33.00/hour Shifts
9-6 pm Monday-Friday Equal Opportunity Employer
SBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status. Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Facilities Services
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