Quality Documentation Specialist
Quality Documentation Specialist
Office based position
40 hours/ week. Mon-Fri schedule, either 7am to 4pm or 8am to 5pm working hours.
1 year contract position, possibility of longer term depending on performance
This position is responsible for providing Quality Documentation Systems support for the Temecula and Ramona sites. Ensures compliance with ISO 9001, ISO 13485, and FDA QSR. Prepares and coordinates Quality and Regulatory system documents and reports as needed for the Temecula and/or Ramona site.
Maintain a compliant Quality and Regulatory documentation system in accordance with the Divisional Quality and Site Quality Management System and applicable standards and regulations.
Significant focus will be in the support of documents required for Device Master File, Device Master Record, Design History File, Product Technical File compliance, and Annual Product Review / Post Market Surveillance compliance.
Provide technical support to internal and external customers in the achievement of a compliant Quality Management System.
Lead and direct Investigative, RCA and CAPA support as identified through the site audit systems.
Assist in providing support for performing internal quality system audit(s).
Assist in providing technical documentation support for product Design and Development and New Product Introduction/Technical Transfer and/or Engineering programs.
Writes and revises Standard Operating Procedures as needed.
May be required to perform additional duties as assigned.
Working hours: 8:00 AM - 4:30 PM
Strong understanding of Quality System Regulations and ISO 9001 / ISO 13485 standards.
Able to work well in a team environment.
Ability to work and communicate effectively with all areas and levels of the organization.
Excellent analytical skills.
Excellent oral and written communication skills.
Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks.
Technical certification in Life Sciences, Engineering, or Regulatory Management field required.
High School Diploma or Equivalent required.
A minimum of 2 years in Quality or Lab Sciences along with experience working in a Class II or Class III drug manufacturing, medical device, or biologics industry in Regulatory Management, Quality Assurance or Quality Engineering position.
Experience in Technical Writing and Audit procedures preferred.
This is a contract position through Randstad. Hourly pay is based on experience.
Please email Rebecca.Ricksgers@external.milliporesigma.com or call my desk line at 951-514-4501. We look forward to hearing from you!
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