QA Product Specialist

Corden Pharma - A Full-Service CDMO

Provides Quality Assurance leadership in pharmaceutical product lifecycle support at CordenPharma. Responsible for documentation review, GMP compliance, and cross-functional team collaboration.

Posted 6/27/2026full-timeBoulder • Colorado • 🇺🇸 United StatesMid-LevelSenior💰 $100,000 - $118,000 per yearWebsite

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceGMPprocess validationtechnical transferChange ControlsMaster Batch RecordsValidation ProtocolsQuality Risk AssessmentsCorrective Actions Preventative Actions (CAPAs)product quality metrics

Soft Skills

communicationcollaborationleadershipdecision-makingproblem-solvingpresentation skillscustomer interactionanalytical thinkingscientific thinkingproject management

Tools & Technologies

cGMP documentationregulatory filingsCorden SOPsQuality Control systemsauditing toolsstatistical analysis softwareproject management softwaredata analysis toolsmanufacturing processespackaging systems

Industry Keywords

Pharmaceutical Industryclinical developmentregulatory inspectionsinternal auditsexternal auditsquality inspectionsscientific journalsanalytical journalsquality metricsproduct lifecycle

About the role

Key responsibilities & impact

Provides Quality Assurance related product leadership as it relates to planning and execution of products.
Responsible for the collaboration, review, and approval of GMP documents.
Represents a high-level of GMP understanding and accomplishment.
Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative supporting the lifecycle of products for internal and external customers.
Responsible for clear, direct, and appropriate communication in customer interactions.
Provide process support including process validation, technical transfer, and commercial activities. May include clinical development as needed.
Collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation.
Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs).
Create, report, and communicate product-related quality metrics to internal and external stakeholders.
Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction.
Provide Quality leadership and decision-making on cross-functional teams that include but are not limited to Operations, Process Engineering, Quality Control, and Safety.
Perform final product batch disposition.
Assist in and represent Quality during internal and external audits and regulatory inspections.
Perform other duties as needed to support CordenPharma initiatives and improvements.

Requirements

What you’ll need

Bachelor’s Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience.
Project Management experience, although not required, is beneficial to this position.
Ability to read, analyze, and interpret common scientific and analytical journals.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to communicate information to customers and senior management.
Ability to effectively present information to top management and public groups.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

Benefits

Comp & perks

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance