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Quality Assurance Associate

Location: Jupiter, FL
Reports To: Vice President, Quality
Status: Exempt 

Position Summary
The Quality Assurance Engineer is responsible to author and maintain Quality System documents, records, and resource materials. This person will also coordinate 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 Quality Assurance Engineer 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.

Job performance will involve a variety of activities including:

  • Implements and ensures adherence to appropriate quality standards
  • Supports development, implementation, and maintenance of the Quality Management System
  • Performs QA reviews of product shipment releases, training records, and deviation reports
  • Manages Document Control activities including setup, documentation system, training employees on proper documentation procedures and writing SOPs
  • Assist with writing verification/validation and stability reports, product stability monitoring and reports
  • Coordinates supplier corrective action activities with purchasing and the supplier quality assurance personnel for supplier quality issues related to the assigned product lines
  • Establishes and / or improves product/ process quality individually and through team-based problem- solving efforts using Industry Best Practices tools
  • Reviews processes and ensures the proper use of effective documentation
  • Interacts with management and other departments on special projects
  • Authors, reviews and/or approves SOPs, work instructions, forms and controlled logbooks
  • Assists department personnel with editing and releasing controlled procedures and documents
  • Tracks metrics pertaining to the Quality System
  • Participates in regulatory, internal and customer audits
  • Monitors the supplies process
  • 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
  • Ambitious, eager to learn and aptitude for technology
  • Experience working with an eQMS system considered a plus

About Alphazyme
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.

Need a custom enzyme developed?
Need an enzyme manufactured to scale?
No problem!
Please contact us to discuss your custom project.