KBI Biopharma Senior Quality Assurance Specialist in Boulder, Colorado
Responsibilities:Responsible for performing activities of the QA Analytical Review System andto work closely with the Program Management team to facilitate communicationsbetween KBI and clients regarding quality-related events. The QualityAnalytical Representative interacts directly with clients and providesexemplary service to both internal and external customers by ensuring patientsafety and regulatory compliance while supporting product lifecycle activitiesfor timely delivery of products to clients for patients.Support cGMP manufacturing operations for manufactured biopharmaceuticalproducts. Responsibilities include:Performs QA analytical review of analytical test methods, includingprotocols and reports.Ensure verification of associated data and audit trail review has beencompleted by appropriate QC personnel.Performs QA analytical review of finished product testing resultsReviews and approve laboratory investigationsProvides QA Client support and is the key Quality contact for Client issues.Track, trend, compile and report client specific quality metrics asnecessary. Specific data will be reported out at client meetings andManagement Review meetings.Performs complaint investigations and review and approve complaintinvestigations as needed.Experience:Bachelor's degree required in a science/lab related field. Minimum 8 yearspharmaceutical industry experience and 5 years of analytical testing,including analytical test method validation.Familiar with quality operating procedures, quality and regulatoryrequirements pertinent to pharmaceutical, biological, biochemical quality.Knowledgeable of worldwide regulatory requirements.Demonstrate strong interpersonal skills, ability to work in a teamenvironment, attention to details and excellent problem resolution skills.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 Vietnam veteranstatus, are strongly encouraged to apply.