Specialist QA

Description:
Perform one or more of the following duties and responsibilities in support of site Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

EDUCATION: Doctorate degree or Masters degree and 3 years of directly related experience or Bachelors degree and 5 years of directly related experience or Associates degree and 10 years of directly related experience.

FUNCTIONS Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, and stored, according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations. Review and approval of Electronic Batch Records and related documentation to support Drug Substance Disposition Process. Performs SAP systems transactions to support batch processing and disposition requirements. Data entry, review and approval of LIMS sample test results to support batch processing and disposition requirements. Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformance s, CAPAs, and validations Supports Continual Improvement initiatives, programs and projects Ensures that deviations from established procedures are investigated and documented per procedures Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures Alerts senior management of quality, compliance, supply and safety risks Represents the quality unit during audits and inspections as needed Completes required assigned training to permit execution of required tasks Performs additional duties as specified by management

PREFERRED QUALIFICATION Project management skills Strong organizational skills, including ability to follow assignments through to completion Initiate and lead cross functional teams Enhanced skills in leading, influencing and negotiating Strong knowledge in area of expertise Collaborate and coordinate with higher level outside resources Strong knowledge of and experience with processes involved in manufacturing, QA, QC, validation and process development Demonstrate ability to interact with regulatory agencies

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation. Ability to evaluate compliance issues, Demonstrate site Values/Leadership Practices.