Doctorate degree or Master’s degree and 3 years of quality experience or Bachelor’s degree and 5 years of quality experience o Bachelor degree in Sciences, Engineering, Computer Sciences, Pharmacy.
o Experience in biopharmaceutical, working with Change Controls, CAPAs, Deviations, Risk Assessments, Technical Reports, Validation reports, Maximo, trackwise
o Experience writing technical reports, annual reports, deviations
o Experience in Audit Readiness and Auditing by a regulatory agency (FDA, MHRA, EU, etc)
o Experience as Quality reviewers and approver of different GMP records
Mostly first Shift (7-3:30pm) but also could be an intermediate shift 10-6:30pm, and may include Saturday and Sunday, and/or Holiday periods
Perform one or more of the following duties and responsibilities in support of Client’s 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.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.
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 the Client Values/Leadership Practices.