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Quality Assurance Specialist

Fremont, CA • Full Time

Job Description

The Quality Assurance Specialist for Document Control and Training Management will organize, control, and maintain the Document and Training Programs within the company’s Electronic Document Management System.

All candidates will be able to demonstrate a compliance mindset, proficiency in communication (written and verbal), competence with computers and business software, and be timeline focused and flexible in their work scheduling.

Duties & Responsibilities

  • Document Control Coordinator within the EDMS
  • Training Coordinator within the LMS
  • Provide EQMS training to end users
  • Provide EQMS support for end users
  • Support the development of training and qualification curriculums
  • Support the implementation and use of the Electronic Quality Management Systems (i.e., Deviation, CAPA, Change Control, Quality Risk Management, Complaint Handling, Audits)
  • Assist in the maintenance of electronic and/or hard-copy archives for applicable GxP records

Essential Qualifications

  • Associate degree. Batchelor degree in STEM related field preferred.
  • Strong communication skills (written and verbal).
  • Working knowledge of SharePoint or Web-based systems preferred.
  • Experience working in laboratories, libraries, or law offices preferred.
  • Practical understanding of documents and records used within the Pharmaceutical industry.
  • Self-motivated, flexible & creative, able to prioritize, and work in a fast-paced & demanding environment.

Preferred Qualifications

  • The ideal candidate will have knowledge of FDA regulations concerning Good Laboratory Practices (cGLP) and/or Good Manufacturing Practices (cGMP) to ensure compliance to quality standards for documentation, training, and records management.

Eligibility Requirements

  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

Ready to Apply?
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Bionova Scientific is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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