Temporary Quality Specialist, Finished Goods
Company: Yoh, A Day & Zimmermann Company
Location: Allston
Posted on: January 15, 2021
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Job Description:
QA Specialist (Batch Records, OOS, Change Controls, GMP, GDP,
QDoCs, Trackwise) #305575
TITLE/ROLE:
Quality Assurance, Quality Specialist, Finished Goods
AREA:
GMP, GDP Operational QA, Quality Assurance
SUMMARY:
The Quality Specialist works with some degree of independence,
while providing oversight of the development, implementation and
maintenance of relevant quality initiatives in support of oral drug
product manufacturing practices, pharma packaging and labeling
process and artwork requirements.
The QA Specialist completes should be adept at troubleshooting
problems, coordinating and executing activities on multiple complex
projects ensuring alignment with corporate goals and compliance
with all regulatory requirements. This position reports to the
Quality Manager, GDP QA.
Minimum qualifications:
Bachelor's (BS) degree in a scientific or allied health field
3 - 5 years of QA Operational experience supporting GMP pharma/
oral drug product manufacturing, GMP/GDP
3 - 5 years of relevant work in the following areas:
Knowledge of global GMP/GDP requirements governing oral drug
products and knowledge of oral drug product manufacturing
practices
Knowledge of packaging and labeling process and artwork
requirements
Broad GMP Knowledge and understanding across lifecycle of the
product
Strong leadership skills with the ability to thrive in a high
throughput environment
Project Management / Continuous Improvement
Ability to manage projects within corporate objectives and project
timelines
Proficient in utilizing project management processes / tools to
support in meetings, assist with project planning, and facilitate
completion of tasks
Demonstrated ability to work independently to provide QA support
for large, multifaceted projects
Collaboration / Teamwork / Conflict Management
Ability to understand and translate business needs
Represents Quality Assurance (QA) on cross functional working teams
as needed and is recognized for strong communication and
influencing skills
Critical Thinking / Problem Solving
Ability to evaluate quality matters and make decisions utilizing
risk based approach
Flexibility/Adaptability, Attention to detail, Models Core Values
and leadership behaviors
Sense of urgency- ability to act quickly/escalation
process/transparency
Ability to:
Drive results on time every time
Maintain composure under pressure
Take ownership and accountability for shared information
Understand and translate customer needs
Knowledge of applications:
OPM (Oracle)
QDoCCs
Trackwise
MS Office
Key Responsibilities:
Perform disposition activities for Finished Goods in support of
Commercial/Clinical Product, including:
Batch Record Review; Master and Executed Batch Record review and
resolution of comments/issues
Support in evaluations of Investigations/ OOS/ Change Controls
Certificate of Analysis (CoA) review/approval
Status change in Oracle
Archiving of batch documents in electronic document system,
QDoCCS
Root-Cause Analysis (RCA) and product impact assessment for
investigations
Support management with Material Review Board activities, when
necessary
Quality oversight of artwork/ label review, approval, &
implementation for Finished Goods
Provide quality support for planning of product launches and
tracking of new artworks
Assist in packaging validation activities as needed
Develops relationships with strategic external partners in support
of expanding portfolio.
QP Relationship and Release
Facilitate QP Release of finished goods
Assist with QP Declaration requests as needed
Incorporate QP expectations into quality systems
Provide compliance guidance to project teams
Collaborative reviewer of internal procedures
Investigation guidance
Understand and support Business Partner needs
Establishment of Quality Processes/Process Ownership - Packaging
/Labeling and QP Release of Finished Goods
Serve as review/approver or owner of deviations
Monitors and trends events and identifies/proposes corrective
actions
CAPA; May serve as Corrective and Preventive Action CAPA owner
Identifies risks and communicates gaps to management
Assists with the generation of
process related metrics/monitors for efficiency
Change Control
Serve as QA assessor/approver: resolve gaps, assist in change
plans, classifications, strategy for GMP release and disposition
strategy
Support deployment of the Quality Management System (QMS) as GMP
Representative:
Conduct ongoing monitoring of regulations and participate in update
of Quality Systems Policy statements
Coordinate, Facilitate and Follow-up for Quality Leadership
Team
May participate on process improvement initiatives
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Please e-mail your resume to philip.cooke@yoh.com
?
Please then call Phil at 860.405.7181
#ZipSPG
#LI-PC1
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a
protected veteran. Visit
https://www.yoh.com/applicants-with-disabilities to contact us if
you are an individual with a disability and require accommodation
in the application process.PandoLogic.Category: Quality Control,
Keywords: Quality Control / Quality Assurance Specialist
Keywords: Yoh, A Day & Zimmermann Company, Boston , Temporary Quality Specialist, Finished Goods, Other , Allston, Massachusetts
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