Corden Pharma - A Full-Service CDMO
QA Analytical Project Specialist - Temporary Position
Corden Pharma - A Full-Service CDMO, Boulder, Colorado, United States, 80301
Overview
QA Analytical Project Specialist - Temporary Position at
Corden Pharma - A Full-Service CDMO . Provides Quality Assurance related project assistance as it relates to analytical methods and specifications for both development and commercial products. Requires in-depth GMP understanding and accomplishment. Acts as the Quality representative for new products/projects, providing strong Quality leadership and scientific/GMP information support to the plant-site. Serves as QA liaison to R&D and other departments. Responsibilities
Provide QA related project assistance for analytical methods and specifications Ensure analytical methods are current with respect to compendial updates Support analytical aspects of new product introduction Support analytical aspects of existing products, including method validation, method transfers, revisions, and specifications Review and approve protocols and reports for stability and reference standards Act as liaison between QA and other departments for change controls (emphasis on analytical changes) Serve as QA representative for laboratory investigations Ensure manufacturing processes, packaging, and testing comply with regulatory filings and Corden SOPs to support quality inspections and customer satisfaction Serve as QA liaison on product/project implementation teams Support the implementation of new processes and new business opportunities Provide analytical and basic statistical information for annual product reviews Qualifications
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 Education and 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 strong knowledge in Analytical Chemistry. Project management experience is beneficial. Skills & Requirements
Language skills: Ability to read, analyze, and interpret common scientific and analytical journals; communicate with customers, regulatory agencies, and senior management. Mathematical skills: apply frequency distributions, test reliability/validity, ANOVA, correlation techniques, sampling theory, and factor analysis. Reasoning ability: apply logical/scientific thinking to problems. Salary
Base pay range:
$88,551.00/yr - $111,374.00/yr Benefits
This is not a Corden Pharma employee position. This position is employed through a temporary agency. Benefits are those provided by the temporary agency. Equal Opportunity Employer
Corden Pharma provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. CORE COMPETENCIES include: customer service, knowledge of cGMP/cGLP/FDA regulations, validation principles, communication, leadership in QA and development processes, interdisciplinary analytical skills, and proactive problem solving.
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QA Analytical Project Specialist - Temporary Position at
Corden Pharma - A Full-Service CDMO . Provides Quality Assurance related project assistance as it relates to analytical methods and specifications for both development and commercial products. Requires in-depth GMP understanding and accomplishment. Acts as the Quality representative for new products/projects, providing strong Quality leadership and scientific/GMP information support to the plant-site. Serves as QA liaison to R&D and other departments. Responsibilities
Provide QA related project assistance for analytical methods and specifications Ensure analytical methods are current with respect to compendial updates Support analytical aspects of new product introduction Support analytical aspects of existing products, including method validation, method transfers, revisions, and specifications Review and approve protocols and reports for stability and reference standards Act as liaison between QA and other departments for change controls (emphasis on analytical changes) Serve as QA representative for laboratory investigations Ensure manufacturing processes, packaging, and testing comply with regulatory filings and Corden SOPs to support quality inspections and customer satisfaction Serve as QA liaison on product/project implementation teams Support the implementation of new processes and new business opportunities Provide analytical and basic statistical information for annual product reviews Qualifications
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 Education and 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 strong knowledge in Analytical Chemistry. Project management experience is beneficial. Skills & Requirements
Language skills: Ability to read, analyze, and interpret common scientific and analytical journals; communicate with customers, regulatory agencies, and senior management. Mathematical skills: apply frequency distributions, test reliability/validity, ANOVA, correlation techniques, sampling theory, and factor analysis. Reasoning ability: apply logical/scientific thinking to problems. Salary
Base pay range:
$88,551.00/yr - $111,374.00/yr Benefits
This is not a Corden Pharma employee position. This position is employed through a temporary agency. Benefits are those provided by the temporary agency. Equal Opportunity Employer
Corden Pharma provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices. CORE COMPETENCIES include: customer service, knowledge of cGMP/cGLP/FDA regulations, validation principles, communication, leadership in QA and development processes, interdisciplinary analytical skills, and proactive problem solving.
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