Documentation Specialist
2 months ago
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.
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.
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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