QA Product Specialist

Jobtailor; Boulder (CO); On-site; USD 110,000 - 170,000; Full time

Job summary

Jobtailor in Boulder, Colorado seeks a Quality Assurance leader to guide GMP-compliant product lifecycle activities. You will approve CAPAs, changes, and batch records while collaborating with Operations, Process Engineering, and Quality groups. Strong QA leadership and regulatory interactions are essential.

The role emphasizes process validation, technical transfer, and ensuring product quality against regulatory filings and customer expectations.

Qualifications

• Bachelor’s degree and 5+ years of QA experience in the pharmaceutical industry.
• Experience reading and interpreting scientific/analytical journals.
• Ability to respond to inquiries from regulatory agencies and customers.

Responsibilities

• Provide QA leadership across lifecycle of pharma products.
• Collaborate on GMP documents and approve changes.
• Lead investigations and CAPAs with cross-functional teams.
• Dispost final product batches and support regulatory inspections.
• Report quality metrics to internal/external stakeholders.

Skills

Quality Assurance

GMP

Process validation

Technical transfer

Change Controls

Master Batch Records

Validation Protocols

Quality Risk Assessments

CAPAs

Product quality metrics

Education

Bachelor’s Degree in Science

Job description

Responsibilities

• 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

• 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.

Hard Skills

• Quality Assurance
• GMP
• process validation
• technical transfer
• Change Controls
• Master Batch Records
• Validation Protocols
• Quality Risk Assessments
• Corrective Actions Preventative Actions (CAPAs)
• product quality metrics

Soft Skills

• communication
• collaboration
• leadership
• decision‑making
• problem‑solving
• presentation skills
• customer interaction
• analytical thinking
• scientific thinking
• project management