QA Product Specialist

Corden Pharma Colorado • Boulder, CO, US, CO

12h • $100,000 - $118,000 • Onsite

About The Position

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.

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.
• 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

Nice To Haves

• Project Management experience, although not required, is beneficial to this position.

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
• Responsible for providing Quality leadership throughout the lifecycle of a product.
• Supports training for QA Associates and other quality personnel.
• Carries out leadership responsibilities in accordance with Corden policies and applicable laws.
• Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and 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 Parental Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level