QA Document Specialist

Proclinical is currently recruiting with a QA Document Specialist with a leading biotechnology company located in San Diego, CA. As the QA Document Specialist, you will manage document control activities, including but not limited to, change control, training, and maintenance of documents. Track, scan, archive, and manage quality-controlled documents and quality records, including training records, forms, specifications and batch records.

Job Responsibilities:

• Manage document control, change control and training processes for GxP activities.
• Prepare and handle documents and procedures for review, approval, and execution.
• Develop, review and revise documentation procedures.
• Establish and maintain records management process including scan, storage, archival and retention.
• Handle and track change control activities and ensure timely approval and closure.
• Oversee on boarding and on-going training program, tracking and maintaining training records.
• Perform other duties, as assigned.

Skills and Requirements:

• Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
• 4+ years of relevant bio-pharmaceutical industry experience, with a 2+ years of document management role.
• Knowledge of GMP and GDP regulatory requirements.
• Self-motivated, excellent organizational skills, and ability to prioritize effectively.
• Ability to work and make decisions independently and as part of a team.
• Strong and effective verbal, interpersonal, and written communication skills.
• Strong collaboration, strategic thinking, leadership, and teamwork skills.
• Advanced computer skills.
• Preference- EDMS experience.

If you are having difficulty in applying or if you have any questions, please contact Damian Albera at d.albera@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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