• Job Description

  Req#: 532524

  
  

  EQUAL OPPORTUNITY EMPLOYER

  Corden Pharma provides equal employment opportunities to all employees and applicants for employment 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.

  
  

  CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

  Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

  SUMMARY

  This role will support all Quality Assurance activities related to cleaning verification and validation for CordenPharma Colorado and CordenPharma Boulder in accordance with the appropriate cGMP requirements for an API Contract Manufacturing and Development Organization (CDMO). Assures consistent quality of products by developing and enforcing cGMP Systems as related to cleaning activities. The individual will assure that processes, documentation, and systems conform to internal quality standards.

  This position will be responsible for identifying potential challenges with respect to compliance, production, or testing activities related to cleanability and potential carryover risk. This role will provide Quality oversight for equipment, standard operating procedures, change controls, deviations, CAPA and technical documents, and other tasks as assigned.

  ESSENTIAL DUTIES AND RESPONSIBILITIES

  Include the following. Other duties may be assigned.

  • Approves and provides quality oversight on cleaning strategy documents, cleaning verification and validation protocols, cleaning auxiliary documents (as applicable) and change controls, deviation, and CAPAs

  • Works directly with Manufacturing and other departments responsible for cleaning activities to resolve deviations and other compliance issues in a timely manner

  • Provides Quality Assurance oversight on equipment upgrades and qualification projects, as related to improvements in cleanability and to reduce carryover risk
  • Participates and provides quality oversight in equipment cleanability assessment and equipment cleaning risk assessments as necessary
  • Participates and provides quality oversight on equipment cleaning related operational excellence projects
  • Trains and mentors other Quality Department staff on equipment cleaning requirements

  LEADERSHIP & BUDGET RESPONSIBILITIES

  None.

  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 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

  High School Diploma or General Education Degree (GED) and 3 years related experience in the pharmaceutical industry; or equivalent combination of education and experience. An understanding of Chemical Concepts and cGMP Manufacturing preferred.

  LANGUAGE SKILLS

  Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, regulatory agencies, and/or boards of directors.

  MATHEMATICAL SKILLS

  Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.

  REASONING ABILITY

  Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

  CERTIFICATES, LICENSES, REGISTRATIONS

  None.

  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; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, 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 occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. 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.

  • Knowledge of chemical processing equipment, chemical processing, cleaning, validation, and high potent and cGMP operations
  • Familiarity with Manufacturing and Regulatory Requirements for cleaning validation
  • Good customer service skills, as well as effective interpersonal and conflict resolution skill
  • Strong math skills
  • Strong reading comprehension
  • Demonstrated mechanical aptitude
  • Demonstrated training and facilitation skills
  • Excellent written and verbal communication skills
  • Effective writing and editing skills; attention to detail is a must

  SALARY

  Actual pay will be based on your skills and experience.

  BENEFITS

  • 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
  • Accident Plan
  • Critical Illness Insurance
  • Dental Insurance
  • Disability Insurance
  • Employee Assistance Program
  • Flexible Spending Account
  • Health Insurance PPO/HSA
  • Hospital Indemnity Plan
  • ID Theft Protection
  • Life Insurance
  • Paid Maternity/Paternity Leave
  • Tuition Reimbursement
  • Wellness Program
  • Vacation – Three Weeks 1st Year
  • Vision Insurance

  This post will expire on June 28, 2025

• About the company

  CordenPharma's global, full-service CDMO for API production, drug products, & packaging services with a network of cGMP facilities across Europe & the US.

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