Quality Systems Specialist, Document Control

Twelve is a new kind of chemical company built for the climate era. Our breakthrough technology eliminates emissions by turning CO2 into essential products. We are a team of scientists, engineers and problem solvers on a mission to fundamentally shift the way the world addresses climate change and lead the transition to a fossil free future with our carbon transformation technology.

Job Brief

We are currently embarking on a new chapter at Twelve. As we look to expand our manufacturing facilities we are looking to grow the Quality Assurance team.  

The Quality Systems Specialist, Document Control is one of the more important functions on the Quality team. The Quality Systems Specialist will lead and maintain the document flow in several key areas within the Quality Department. This includes recommending improvements in the procedures used to control documents to enhance overall document accuracy, storage and retrieval capabilities. This role will report to the Quality Manager.  The team will be responsible for overseeing implementing ISO 9001:2015 across the organization and several sites. The ideal candidate will work closely with R&D and Production to support new product introduction through ERP and TQM systems. 

The Quality Assurance team at Twelve manages processes verifying the predetermined services and specified requirements. The QA team assists in bridging the process across cross functional teams.  We are the positive regulators validating the desired expectations to ensure Twelve's technological advantages remain sustainable.

What you will do 

• Develop and maintain overall document control structure within the document management system.
• Maintain regulatory licensure and accreditation documentation; develop and maintain a spreadsheet of licensure and accreditation effective/expiration dates with renewal requirements.
• Support development of system and process improvements that would enhance compliance to documentation/training requirements.
• Perform periodic audits and inspections of Quality System activities which may include but is not limited to clinical study work and records, study reports, laboratory method SOPs, product batch records, and other quality records, processes, and activities
• Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate
• Support platforms and tools utilized for the performance of Quality System activities such as the Document Control System, Quality Management system, certification/accreditation database, and those required for regulatory contacts or other purposes.
• Perform review of validation SOPs, protocols, plans, reports and documentation for compliance to Quality System and regulatory requirements.
• CAPA process - tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
• Internal Audit program - planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit.
• Quality Agreements - maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision

 Who you are 

• Bachelor's degree (preferred)
• Minimum of Five (5) years relevant experience or two (2) years relevant experience with an advanced degree required.
• Previous Quality Assurance experience within a GMP regulated environment required
• Strong understanding of Quality Management Systems and experience with ISO 9001 preferred, auditor certification a plus.
• High degree of computer literacy, experience with ERP systems (SAP) preferred
• Strong experience in technical writing is highly preferred

Twelve Benefits

• Medical, dental, and vision coverage
• Paid sick days and vacation
• Competitive salary and equity compensation commensurate with experience
• Diverse and inclusive work environment

We believe that the unique contributions of each individual is the driver of our success. To make sure that our products and culture continue to incorporate everyone's perspectives and experience we never discriminate on the basis of race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status.

Want to work with us but don't see a current opening that fits your background? Email us at talent@twelve.co.