QA Analytical Project Specialist - Temporary Position

CORDEN PHARMA BOULDER INC • CO

95d

About The Position

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

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
• 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

Nice To Haves

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

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 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

Benefits

• Benefits are those provided by the temporary agency

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees