QA Analytical Project Specialist

Corden Pharma Colorado• Boulder, CO, US, CO

2d•Onsite

About The Position

Provides Quality Assurance related project assistance as it relates to analytical methods and specifications for both development and commercial products. Requires in-depth understanding and accomplishment of GMP. Responsible for providing strong Quality leadership and scientific/GMP information support to the plant-site as the Quality representative for new products/projects. Serves as the Quality Assurance liaison to R&D and other departments.

Requirements

Knowledge of cGMPs as they apply to documentation protocol and analytical method validation activities
Ability to apply attention to detail, regulatory requirements, and a practical, defendable, logical approach to problem solving
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, 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 principles of validation and their application
Excellent verbal, presentation, and written communication skills
Provide leadership in all aspects of QA and development processes
Analytical skills with the ability to function with interdisciplinary teams
Proactive approach to problem solving and resolution

Nice To Haves

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

Responsibilities

Ensuring analytical methods are current with respect to compendial updates
Supporting analytical aspects of new product introduction
Supporting analytical aspects of existing products to include, but not limited to, method validation, method transfers, revision of methods, and specifications
Review and approval of protocols, and reports for stability and reference standards
Liaison between QA and other departments for review and approval of change control (with an emphasis on analytical changes)
QA representative for laboratory investigations
Assuring that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction
Serving as QA liaison on product/project implementation teams
Supporting the implementation of new processes and new business opportunities proposed for implementation into development and/or manufacturing
Providing analytical and basic statistical information for annual product reviews
Providing Quality leadership on new technology, new opportunities and large projects and technology transfers.

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