QC Stability Study Coordinator I

Vacaville, CA, US • Posted 4 days ago • Updated 1 day ago

Contract Corp To Corp

Contract Independent

Contract W2

On-site

$20 - $30/hr

Keen Technology Solutions LLC

Fitment

Dice Job Match Score™

🤯 Applying directly to the forehead...

Job Details

Skills

Routine Master Data Testing Creation
Routine Master Data Testing Review
Annual Product Quality Reviews (APQRs)
Time Point Approval assistance

Summary

QC Stability Study Coordinator I

Vacaville, CA

Duration: 1 Year

Onsite

Summary
With limited supervision, QC Stability Study Coordinator, is responsible for the oversight of stability program management in accordance with cGMP regulations. These duties include execution of trend analysis, documentation review, support of deviations (OOS, OOT, OOE) and other laboratory support activities. In conjunction with Quality Control leadership, the QC Stability Study Coordinator works to meet departmental and organizational goals.

Job Responsibilities
Review data and assess against established acceptance criteria
Perform technical review of peer-generated data
Evaluate data to identify trends and/or establish limits
Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
Identify and troubleshoot technical problems
Identify gaps in systems and procedures
Receive training
Support the maintenance and compliance of operational areas
Assure and apply GMP throughout operations
Coordinate with customers to support multi-site operational activities
Support internal and external audits and regulatory inspections
Works to meet schedules, timelines, deadlines
Participate in and/or lead group and project teamwork; project and process improvements
Stability Protocol Creation
Stability deviation assessments
Routine Master Data Testing Creation
Routine Master Data Testing Review
Routine and non-routine Out Of Trend linear regression assessments.
Annual Product Quality Reviews (APQRs) - Author assistance develop to authoring
Time Point Approval assistance
Change control of various documents
Data / Data Table requests / annual report requests (non-routine requests) (e.g.,
Client monitor requests)
Actively participate in various stability related projects
Data entry and review
Assist with training coordination
Assist with Perform other duties as requested by managers to support Quality activities

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91165791
Position Id: 8906919
Posted 4 days ago

Company Info

About Keen Technology Solutions LLC

Keen Technology Solutions headquarted in Irving, TX, with more than 25 Years of IT professional resourcing and managed services, we empower organizations across the full lifecycle of technology adoption, providing flexible solutions that adapt to their needs as technologies and skills evolve.

Keen is a world-class technology services business that incorporates industry insights and experience to deliver solutions that fulfil our clients’ digital visions. We use our unique deployment model to build qualified, industry specialized fit-for-purpose teams combined with proven solutions and service models to achieve results. Our agility and obsession with providing value enables us to support an ever-evolving digital world.

WORKING WITH KEEN
"One big positive for me is Keen ensures there is a continuous dialogue with the client and wants to make sure the candidates are qualified and progressing as expected…. they are professionals with a strong customer focus. Keen Account Managers go the extra mile to ensure qualified candidates are presented and are always keeping in touch. That is important in this business. "

Go to company profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

QA Documentation Specialist-Pharma

Tampa, Florida

•

Yesterday

QA Documentation Specialist Current Location: Tampa, FL 100% on-site The QA Engineer is responsible for ensuring the timely development, review and approval of all engineering, validation and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with corporate procedures, SOPs, cGMP, standards and implementing industry best practices. Key Accountabilities: Responsible for the Quality review and approval of engineering and validation documentation to supp

Easy Apply

Contract

$20 - $30

Search all similar jobs