QA Analytical Project Specialist

Summary

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

• Responsible for ensuring analytical methods are current with respect to compendial updates
• Supports analytical aspects of new product introduction
• Supports analytical aspects of existing products to include, but not limited to, method validation, method transfers, revision of methods, and specifications
• Responsible for 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
• Assures that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction
• Serves as QA liaison on product/project implementation teams
• Supports the implementation of new processes and new business opportunities proposed for implementation into development and/or manufacturing
• Provides analytical and basic statistical information for annual product reviews

Responsible for providing Quality leadership on new technology, new opportunities and large projects and technology transfers. 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.

• 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

Bachelor’s Degree in Science with 5 years of Quality Assurance/Quality Control experience within the Pharmaceutical industry; or a combination of Pharmaceutical industry and academic experience with a strong knowledge in Analytical Chemistry. 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, 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.

None.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit.

The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific visual abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals.

The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

• Excellent customer service skills
• Knowledge of cGMP, cGLP, and FDA…