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