QA Associate: Document Control & Training (Hybrid, Fremont)

Celgard; Fremont (CA); Sur place; USD 55 000 - 62 000; Plein temps

Résumé du poste

Bionova is seeking a motivated QA Associate to join the Quality Assurance department on a 4-6 month assignment with potential renewal. The role focuses on QA oversight of Document Management and Training in the Master Control QMS, located in Fremont, California, with onsite work and hybrid potential.

Responsibilities include managing electronic quality systems, providing training, ensuring GMP compliance, and maintaining controlled documents.

Qualifications

• Associate degree and/or 2+ years of related experience.
• Experience in pharmaceutical or life-sciences industries.
• Experience with electronic quality systems and MasterControl or equivalent.
• Excellent verbal and written communication across departments.

Responsabilités

• Technical acumen and management of electronic quality systems (e.g. Master Control document coordination and control activities).
• Provide user assistance, training, and oversight on document control and record management systems, processes, and procedures.
• Strong working knowledge of GMP practices and how they might apply to SOPs, work instructions, and controlled records.
• Identify and elevate gaps and discrepancies in controlled documents and the processes that govern them.
• Assist users with formatting documents such as SOPs and quality agreements using approved templates.
• Proficient in Microsoft Word formatting including styles, pagination, section breaks, headers/footers.
• Strong grasp of GxP training program requirements and training assignments.
• Ability to promptly respond to email inquiries and user support.

Connaissances

Excellent communication

Multitasking

Independent judgment

Initiative

MS Office proficiency

GxP knowledge

Formation

Associate degree or 2+ years experience

Outils

MasterControl

Learning Management System

Microsoft Office

Description du poste

Bionova is seeking a motivated QA Associate to join the Quality Assurance department on a 4-6 month assignment with potential renewal. The role focuses on QA oversight of Document Management and Training in the Master Control QMS, located in Fremont, California, with onsite work and hybrid potential.

Responsibilities include managing electronic quality systems, providing training, ensuring GMP compliance, and maintaining controlled documents.