Location: Jupiter, FL
Reports To: Vice President, Quality
About the Job
The Document Control Specialist II is responsible to author and maintain Quality System documents, records, and resource materials. He/She also coordinates communication between Alphazyme and its suppliers on SCARs and Quality-related matters. Alphazyme is focused on continuous improvement of its processes to maximize efficiency and minimize waste streams. As a member of the Quality Assurance department, the Document Control Specialist II plays an integral role in identifying opportunities for such improvements.
Key attributes for this role include strong technical writing skills, a process-orientation, and the ability to independently solve problems in a fast-paced environment.
Our Quality Management System allows Alphazyme to reliably manufacture enzymes consumed by industrial partners in important and large applied markets. Your work will support the Company’s mission to be the partner of choice for firms who leverage the power of genomics to address some of the most complex challenges facing humanity today.
- Implements and ensures adherence to appropriate quality standards
- Supports development, implementation, and maintenance of the Quality Management System
- Manages Document Control activities including setup, verification/validation of the eQMS documentation system, training employees on proper documentation procedures and writing SOPs
- Reviews processes and ensures the proper use of effective documentation.
- Interacts with management and other departments on special projects such as ISO training.
- Authors, reviews and/or approves SOPs, work instructions, forms and controlled logbooks
- Assists department personnel with editing and releasing controlled procedures and documents
- Reports metrics pertaining to the Quality System
- Participates in regulatory, internal and customer audits
- Reviews and manages Quality System Records for conformance and compliance
- Controls filing, access, retrieval and retention periods for records and documents
- Maintains Quality System Living Documents and records such as training matrix
- Assures ongoing compliance with quality and industry regulatory standards and requirements
- Recognizes opportunities for improvement, recommends and makes solutions actionable
- Additional duties as assigned
Education / Experience / Skills
- BA/BS or equivalent experience in document control and/or combination of experience and training.
- Minimum 3+ Years of experience in a Pharmaceutical/Biotech or medical device environment
- Experience in ISO/FDA Quality System Regulation environment, medical device preferred
- Excellent written and verbal communication skills
- Initiative and organizational skills
- Proficient with MS Office applications
- Practical working knowledge of electronic documentation systems, data retrieval, and electronic file formats.
- Experience working with an eQMS system considered a plus
Alphazyme was founded in 2018 by experts in the field of enzyme development and production with a track record of success and a passion for supporting innovators in molecular science. Our mission is to be the world’s premier partner for custom, industrial-scale molecular biology enzymes. We partner with the manufacturers of nucleic acid therapies and detection platforms to develop and produce affordable, reliable enzymes which meet the specifications of the rapidly expanding market for custom DNA and RNA molecules, genomic medicines and genetic tests. Consistent quality, scalable production, and compatibility with regulatory requirements are the hallmarks of our business.