KBI Biopharma Principal QA Specialist - Quality Engineering in Boulder, Colorado
This position supports all QA activities related to Facility Engineering andValidation in a Contract Manufacturing and Development Organization(CDMO). Responsibilities include the review and approval of GMPdocumentation, resulting in timely QA oversight of equipment, utilities,IT infrastructure & enterprise systems and processesqualification/validation activities. The individual will assure thatprocesses, facilities, documentation and systems conform to qualitystandards and governmental regulations. This position will be responsible foridentifying potential problems with respect to compliance, production ortesting activities and working with the affected departments to resolve theissues. This role will provide Quality oversight for facility, utility,equipment, IT, and process change controls, deviations, CAPA andTechnical Documents, as well as supports client and regulatory audits andotherProvides input and compliance review on the following records:Qualification/validation plans, protocols, & reports, ChangeControls, Deviations and CAPAs related to facility, utility, equipmentand procWorks directly with manufacturing, the laboratory and other departmentsresponsible for GMP activities to resolve deviations and other complianceissues in a timely manner.Interfaces directly with clients, provides updates and resolves issues.Reviews the following equipment-related documentation: user requirementsspecifications, qualification plans, protocols, and final reports,SOPs, work plan &calibration templates, and out of calibration reports.Creates and reports metrics for Change Control key performance indicators andprovides quality and compliance assessments to senior management as requiredand contributes to strategic direction or initiatives to achieveorganizational effectiveness.Trains and mentors other Quality department staff to perform quality duties.Experience:BS and 12+ years experience or MS and 10+ years experience in a QA or GMPenvironment or equivalent. Inter- and intra-departmental project managementexperience and experience with electronic document management systems desired.Salary Range: 105,000 - 120,000 p/yrSalary range provided per current averages and expectations. The salary andjob title for this opening will be based on the selected candidate'squalifications and experience and may be outside this range. KBI has a robusttotal rewards strategy which includes an annual bonus structure for allemployees, medical, dental, and vision coverage, paid PTO andholidays, 401K matching with 100% vesting in 60 days and employeerecognition pKBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or veteran status, arestrongly encouraged to apply.