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QC Analytical Specialist jobs in United States
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PCCA · 14 hours ago

QC Analytical Specialist

positionHouston, TX
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp
PCCA is a company that helps pharmacists and prescribers create personalized medicine. They are seeking a QC Analytical Specialist who will serve as a subject matter expert in UHPLC and other analytical techniques, responsible for leading analytical testing and ensuring compliance with regulatory requirements.
Pharmaceutical
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Diversity & Inclusion

Responsibilities

Develop, implement, and maintain UHPLC/HPLC methods and analytical protocols
Lead method verification, method transfer, and validation activities in accordance with USP and ICH guidelines
Review and interpret analytical data, ensuring accuracy, completeness, and compliance with cGMP, SOPs, and regulatory expectation
Lead investigations of deviations, out-of-specification (OOS), or out-of-trend (OOT) results related to analytical testing
Troubleshoot laboratory equipment and method performance issues, related to UHPLC, to identify root causes and implement corrective actions
Support complaint investigations directed to Quality Control, providing technical assessment and corrective action
Create, revise, and maintain SOPs, protocols, and other controlled documents
Ensure proper handling, storage, and documentation of laboratory reagents, standards, and samples
Maintain compliance with cGMP regulations, including adherence to data integrity principles
Maintain, calibrate, and troubleshoot laboratory instruments to ensure consistent, accurate, and reliable test results
Drive continuous improvement initiatives to enhance laboratory efficiency, reduce test variability, and strengthen product quality
Serve as the SME for laboratory techniques, analytical methods, and GMP practices
Train and mentor QC Analysts on UHPLC and other analytical techniques
Lead special projects and support cross-functional initiatives as assigned

Qualification

UHPLC expertiseHPLC testingCGMP complianceQuality Management SoftwareRegulatory guidelines knowledgeLaboratory investigationsMethod validationTrainingMicrosoft Office proficiencyMentoring

Required

Bachelor of Science Degree
Minimum of 5 years of experience in a GMP-regulated QC laboratory, with demonstrated expertise in HPLC/UHPLC testing
Strong knowledge of UHPLC analytical techniques, laboratory instrumentation, and cGMP compliance
Experience with laboratory investigations, deviations, OOS/OOT reporting, and corrective actions
Experience with Quality Management Software, preferably MasterControl
Knowledge of regulatory guidelines including FDA, ICH, USP, and EP
Proficiency with Microsoft Office (Word, Excel, Outlook, SharePoint) and ERP systems
Comprehensive knowledge of UHPLC method development, method transfer, and the preparation and execution of analytical protocols

Company

PCCA

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PCCA supports the creation of personalized medicine and innovative products that make a difference in patients’ lives.
dateFounded in 1981
location
Houston, Texas, USA
people-size201-500 employees
web-link
http://www.pccarx.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2010-11-01Grant

Leadership Team

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David Sparks
Chief Executive Officer
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Recent News

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Company data provided by crunchbase