QA Analytical Project Specailist

Job Description

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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 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.

LEADERSHIP & BUDGET RESPONSIBILITIES

Responsible for providing Quality leadership on new technology, new opportunities and large projects and technology transfers. Carries out leadership responsibilities in accordance with company policies and applicable laws.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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 of their knowledge, training, ability and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Knowledge of cGMP’s 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.

EDUCATION and/or EXPERIENCE

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.