QA Specialist - Cleaning

Corden Pharma Colorado

10h

About The Position

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.

Requirements

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

Responsibilities

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

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