Sr Quality Support
Company: Integrated Resources, Inc
Location: Irvine
Posted on: January 12, 2021
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Job Description:
Job Title: Sr Quality SupportJob Location: Irvine, CAJob
Duration: 12 Months (Possible Extension)Summary:This position is
primarily responsible for supporting the change control within the
quality systems organization with focus on QA review and processing
of document changes and change controls within the Electronic
Document Management Systems (EDMS) and TrackWise
system.Additionally, will be Subject Master Expert of the computer
systems support Change Control such as EDMS and TrackWise.You
will:* Provides quality oversight to the change management system
for complex Minor and/or Major Change Controls of documents,
processes, and systems including managing communication with 3rd
party clients pre and post implementation on applicable change
controls.* This includes verifying that proposed changes adhere to
local SOPs and 21 CFR parts 210 and 211 as well as Part 820
requirements while leveraging ICH Q9 and Q10 and ensuring
escalation of potential issues to Client management/ 3rd party
liaisons.* Ensure the health of these systems minimally meet the
KPI metrics established by the global team and site leadership by
routinely monitoring and managing corrective actions when needed.*
Become SME for EDMS (ClientDoc and Wisdom) and TrackWise for change
control and serve as back up other elements within the site's
quality systems such as LIMS and SAP.* Draft new and revise
existing procedures to ensure implementation of continuous
improvements/compliance changes related to quality systems
processes.* Participates in inspection readiness activities,
investigations and internal audits with potential to lead
investigations.* Recognize opportunities for improvement and drive
change through collaboration and influencing stakeholders outside
quality department and implements continuous improvement efforts as
they relate to QA.* Solicit information from various departments
and compile PowerPoint presentation for routine quality systems
meetings.* Provide employee training for document change and change
control processes.* Provides guidance to change control owners in
all GMP areas to ensure compliance with all applicable procedures /
regulations and assists in resolution of issues identified.*
Maintain work areas and perform job functions in a safe and
efficient manner in accordance with company policies and
procedures, Good Manufacturing Practices (cGMP's), Standard
Operating Procedures (SOP's) and Batch Record instructions.
Requirements:* Bachelor's degree required in Science or
Engineering.* ASQ Certification preferred.* 5 years related QA
experience in a Pharmaceutical manufacturing environment required.*
Experience working in a Sterile Aseptic manufacturing environment
strongly preferred.* Experience with and an in-depth knowledge of
cGMP and other applicable industry regulatory requirements related
to production of pharmaceutical products and associated quality
systems preferred.* Experience with and in-depth knowledge of
document changes and change control process required.* Experience
with Manufacturing/Quality systems such as TrackWise EDMS and SAP
preferred.* Statistical software JMP or Minitab a plus.* Strong
knowledge of data analysis using MS Excel is preferred.* Computer
proficiency with comprehensive working knowledge of Excel,
PowerPoint, and Word required.* Detail oriented with ability to
identify errors or inconsistencies while performing tasks and to
determine or initiate corrective responses around scope of change.*
Ability to demonstrate sound judgment and decision-making.*
Experience influencing people with history of achieving results and
outstanding outcomes.* Ability to build and maintain collaborative
relationships between teams, departments and business units.
Motivate and influence others without direct authority.*
Self-directed with ability to organize and prioritize work with
little instruction on routine work and under general instructions
on new projects.* Ability to communicate effectively with excellent
written and oral communication skills.* Excellent time management
and organization skills to manage small project.
Keywords: Integrated Resources, Inc, Irvine , Sr Quality Support, Other , Irvine, California
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