QA Associate: Document Control & Training (Hybrid)

Asahi Kasei Bioprocess America, Inc.; United States; Hybrid; USD 55.000 - 62.000; Vollzeit

Benefits dieser Stelle

MasterControl experience

Zusammenfassung

Bionova Scientific LLC in Fremont, California is seeking a QA Associate for a 4- to 6-month assignment to provide QA oversight of Document Management and Training in the Master Control QMS. The role will work hybrid/onsite, with emphasis on GMP-aligned processes and controlled records.

Ideal candidates have 2+ years in pharma or life sciences and experience with electronic quality systems such as MasterControl or equivalent, plus strong communication and Word/Excel skills.

Qualifikationen

• Associate degree and/or 2+ years of related experience.
• Requires at least 2 years of pharmaceutical or life-sciences experience.
• Experience with electronic quality systems and MasterControl or equivalent.
• Excellent communication skills and ability to collaborate with stakeholders.
• Proficiency in Microsoft Word, Excel, PowerPoint.

Aufgaben

• 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.
• Perform administrative tasks to maintain both the electronic document management system.
• Identify and elevate gaps and discrepancies in controlled documents and the processes that govern them (e.g. document formatting, SOP style consistency, clear and concise wording, document change controls, etc.).
• Strong understanding of version and revision control for a variety of controlled document types.
• Assist users with formatting documents such as SOPs, work instructions, or quality agreements using approved templates and finalizing controlled forms.
• Proficient in Microsoft Word formatting including styles, pagination, section breaks, headers and footers, table properties, attachments, and page layouts.
• Strong grasp of GxP training program requirements, including role-based training, curricula hierarchy, instructor led training, and training assignments.
• Ability to promptly respond to email inquiries and user support.

Kenntnisse

Quality assurance

Documentation

Communication skills

Independent work

Ausbildung

Associate’s degree

2+ years pharmaceutical or life-sciences experience

Tools

MasterControl

MS Word

Excel

LMS (Learning Management System)

Jobbeschreibung

Bionova Scientific LLC in Fremont, California is seeking a QA Associate for a 4- to 6-month assignment to provide QA oversight of Document Management and Training in the Master Control QMS. The role will work hybrid/onsite, with emphasis on GMP-aligned processes and controlled records.

Ideal candidates have 2+ years in pharma or life sciences and experience with electronic quality systems such as MasterControl or equivalent, plus strong communication and Word/Excel skills.