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Principal QA Specialist - Quality Engineering

Company: KBI Biopharma
Location: Boulder
Posted on: May 3, 2021

Job Description:

Job Description Job Summary This position supports all QA activities related to Facility Engineering and Validation in a Contract Manufacturing and Development Organization (CDMO). Responsibilities include the review and approval of GMP documentation, resulting in timely QA oversight of equipment, utilities, IT infrastructure & enterprise systems and processes qualification/validation activities. The individual will assure that processes, facilities, documentation and systems conform to quality standards and governmental regulations. This position will be responsible for identifying potential problems with respect to compliance, production or testing activities and working with the affected departments to resolve the issues. This role will provide Quality oversight for facility, utility, equipment, IT, and process change controls, deviations, CAPA and Technical Documents, as well as supports client and regulatory audits and other tasks, as assigned. Provides input and compliance review on the following records: Qualification/validation plans, protocols, & reports, Change Controls, Deviations and CAPAs related to facility, utility, equipment and processes. Works directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner. Interfaces directly with clients, provides updates and resolves issues. Reviews the following equipment-related documentation: user requirements specifications, qualification plans, protocols, and final reports, SOPs, work plan templates, and out of calibration reports. Creates and reports metrics for Change Control key performance indicators and provides quality and compliance assessments to senior management as required and contributes to strategic direction or initiatives to achieve organizational 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 GMP environment or equivalent. Inter- and intra-departmental project management experience and experience with electronic document management systems desired.KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.Read More

Keywords: KBI Biopharma, Boulder , Principal QA Specialist - Quality Engineering, Other , Boulder, Colorado

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