QA Document Control Associate

Description

position at SBM Management

The QA Document Control Associate supports departmental operations by assisting customers with document revision and internal/external document requests.

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.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

education and/or 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 driver’s 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: $26.73-35.50/hour

Shifts: 9-6 pm Monday-Friday

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.

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