Document Control Specialist | Waltham

Avava, Inc.; Waltham (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Avava, Inc. is seeking a Document Control Specialist to manage quality documentation for biomedical applications. The role focuses on compliance, ensuring documents are accurate and accessible. Ideal candidates have solid experience in documentation control and a thorough understanding of industry regulations.

Qualifications

• 5+ years of documentation control experience in biomedical/biotech.
• Familiarity with industry regulations (ISO, GMP).
• Strong organizational and compliance knowledge.

Responsibilities

• Manage and maintain documentation systems ensuring accuracy and compliance.
• Conduct document audits and resolve discrepancies.
• Assist in preparing documentation for internal and external audits.

Skills

Organizational skills

Compliance knowledge

Communication skills

Detail-oriented

Education

Bachelor’s degree or equivalent experience

Tools

Arena PLM system

Document control software

Job description

AVAVA is more than an aesthetics company – it’s a portal to the future of skin vitality. Traditional treatments follow a one-size-fits-all approach.

AVAVA advanced energy products are different. We put patients first by breaking down barriers to develop products that are safe and effective across all skin tones, helping patients achieve their personal skin health goals. Driven by technical precision and imaging to provide clinicians with a “laser eye view” at high resolution.

MIRIA is a next-generation laser with first-in-class features that allow full use of this powerful technology for everyone through a highly personalized treatment whether your skin tone is darker, lighter, or anywhere in between.

AVAVA pushes the limits of innovation, leveraging power and precision to offer personalized solutions for all.

JOB SUMMARY

We are seeking a skilled and experienced Document Control Specialist to join our team! The Document Control Specialist will manage and controls quality documentation, ensuring all documents are accurate, up-to-date, and accessible to relevant stakeholders. Support continuous improvement initiatives by streamlining document control processes. This role is critical to ensuring accuracy, compliance, and organization of the company’s documentation processes.

Job Duties

• Manage and maintain documentation systems, ensuring all documents are up-to-date, accurate, and compliant with industry standards and regulations.
• Maintain revision control of all controlled documents via document control system
• ManageChange Order Requests, andReview Change Orders for completeness and accuracy before routing for approval
• Work with change order initiators to ensure their change orders comply with document control procedures.
• Works with a variety of SMEs from various departments to quickly update documents while ensuring compliance with documentation control procedures (e.g. Disposition,Implementationtasks assign, etc.)
• Oversee the document control process, including document creation, revision, and archiving.
• Conduct document audits and address discrepancies.
• Assist in preparing documentation for internal and external audits.

Qualifications

• 5+ years of documentation control experience in the biomedical and/ or biotech industries.
• Bachelor’s degree or equivalent experience in quality or documentation management.
• Extensive experience working with the Arena PLM system is required.
• Experience with document control software
• Strong organizational and compliance knowledge
• Detail-oriented with excellent communication skills
• Familiarity with industry regulations (e.g., ISO, GMP) related to documentation

AVAVA, Inc. complies with all aspects of the Americans with Disabilities Act (ADA) and state disability laws. This means that we will not discriminate against qualified individuals with a disability in any phase of the employment relationship including application for employment, hiring, promotions and/or advancement opportunities, termination, compensation, training, and any other conditions or privileges of employment.

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Document Control Specialist | Waltham

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