KBI Biopharma Senior Quality Assurance Specialist - Quality Engineering in Boulder, Colorado
Responsibilities: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 and 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, and 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.Works 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.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.Participates in client project teams.Experience:BS or MS with 8 - 16 years' experience in a QA or GMP environment orequivalent. Inter- and intra-departmental project management experience andexperience with electronic document management systems desired.KBI 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.