Quality Assurance Associate

Company: Alphazyme LLC
Location: Jupiter
Posted on: February 19, 2021

Job Description:

The Quality Assurance Associate 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 Associate 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.RESPONSIBILITIES* 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 assignedEducation / 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

Keywords: Alphazyme LLC, Jupiter , Quality Assurance Associate, Other , Jupiter, Florida