Documentation Specialist

2 months ago


Santa Monica, California, United States MassGenics Full time
Job Summary

We are seeking a highly skilled Quality Assurance Documentation Specialist to join our team at MassGenics. As a key member of our documentation team, you will be responsible for ensuring the accuracy and timeliness of our documentation processes.

Key Responsibilities
  • Implement Change Requests (CR), Document Change Orders (DCOs), and Documents in a timely and accurate manner.
  • Maintain documentation manuals to ensure accuracy and current information.
  • Input database entries, verify own work, and ensure the correct and timely implementation of documentation processes.
  • Support the distribution and maintenance of GXP documentation.
  • Scan, verify, and archive documentation as needed.
  • Recommend process improvements and propose changes to enhance documentation efficiency.
  • Provide support with internal and regulatory audits/inspections as required.
  • Provide user training for electronic systems as applicable.
  • Create and maintain document templates.
  • Assist with the periodic review process.
  • Support the maintenance of monthly document control metrics.
  • Perform general word processing tasks and support.
  • Check format and conformance to document templates, verify own work.
  • Provide additional support and assistance on tasks and projects as directed by management.
  • Participate in training on issues affecting own area of work.
  • Notify manager of compliance questions and issues.
Requirements

To be successful in this role, you will need:

  • Excellent communication and organizational skills.
  • Ability to work accurately and efficiently in a fast-paced environment.
  • Strong attention to detail and ability to maintain high-quality documentation.
  • Proficiency in word processing and database management software.
  • Ability to work collaboratively as part of a team.
What We Offer

At MassGenics, we offer a competitive salary and benefits package, including:

  • Medical and pharmacy coverage.
  • Dental and vision insurance.
  • 401(k) plan.
  • Health savings account (HSA) and flexible spending account (FSA).
  • Life insurance.
  • Pet insurance.
  • Short-term and long-term disability insurance.
  • Accident and critical illness coverage.
  • Pre-paid legal and ID theft protection.
  • Sick time and other types of paid leaves (as required by law).
  • Employee assistance program (EAP).


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