Corden Pharma - A Full-Service CDMO · 10 hours ago
QA Product Specialist
Boulder, CO
Full-time
Onsite
Senior Level
$89K/yr - $111K/yr
5+ years expCorden Pharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients and pharmaceuticals. The QA Product Specialist is responsible for providing quality assurance leadership, collaborating on GMP documentation, and ensuring compliance with regulatory standards to support product lifecycle for internal and external customers.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Represent QA for all Quality related customer interactions for one or more products. 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
Qualification
Required
Bachelor's Degree in Science
5 years of Quality Assurance experience within the Pharmaceutical Industry
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
Excellent customer service skills
Knowledge of cGMP, cGLP, and FDA regulations, as well as internal quality related procedures
Practical and theoretical knowledge of the basic principle of validation and their applications
Analytical ability and ability to influence
Excellent verbal, presentation, and written communication skills
Ability to provide leadership in all aspects of QA/development processes
Analytical skills with the ability to function in an interactive interdisciplinary team environment
Proactive approach to problem solving and resolution
Preferred
Project Management experience
Benefits
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 Maternity/Paternity Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance
Company
Corden Pharma - A Full-Service CDMO
CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Lipid Excipients, Drug Products and Packaging.
1001-5000 employees
H1B Sponsorship
Corden Pharma - A Full-Service CDMO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2022-05-02Acquired
Leadership Team
Mimoun Ayoub
Senior VP, Global Head of Sales & Key Account Management
Recent News
2025-09-23
Company data provided by crunchbase