QA Project Specialist
Job # 1814
Corden Pharma Colorado


SUMMARY
Provides Quality Assurance related project assistance as it related to project implementation.   Represents the highest level of GMP understanding and accomplishment.  Responsible for providing strong Quality leadership and scientific/GMP information support to the CPC plant-site as the Quality representative for new products/projects.  Is the QA liaison to the technical department.
 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Provides Validation support and during the transition from clinical development to process validation.
  • Liaison between QA and Development for Review and Approval of all required change control for development products
  • 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 Q liaison to the technical department and on product/project implementation teams
  • Supports the Implementation of new processes and new business opportunities proposed for implementation into development and/or manufacturing
 
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 Corden 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.
 
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in Science and/or 5 years of Quality Assurance experience within the pharmaceutical industry or a combination of pharmaceutical industry and academic experience.  Project management experience although not required is beneficial to this position.
 
LANGUAGE SKILLS
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.
 
MATHEMATICAL SKILLS
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.
 
REASONING ABILITY
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. 
 
PHYSICAL DEMANDS 
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.
 
WORK ENVIRONMENT 
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. 
 
CORE COMPETENCIES 
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
 
  • 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 principle of validation and their applications
  • Analytical ability, ability to influence
  • Excellent verbal, presentation and written communication skills
  • Ability to provide leadership in all aspects of QA/development processes.
  • Analytical skills with the ability to function in an interactive interdisciplinary team environment
  • Proactive approach to problem solving and resolution
 
SALARY
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
 
APPLICATION
Please refer to: Job #1814 – QA Project Specialist
Submit resume to cpc_hr@cordenpharma.com