Temporary Quality Specialist, Finished Goods

Company: Yoh, A Day & Zimmermann Company
Location: Somerville
Posted on: January 15, 2021

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

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Please then call Phil at 860.405.7181











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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, Somerville , Temporary Quality Specialist, Finished Goods, Other , Somerville, Massachusetts