Specialist Qa- Batch Record Audit

Experience in Quality performing batch record audit, non-conformances, oversight, on-the-floor support of Manufacturing; additionally, experience applying continuous improvement and Lean principles to reduce lead times and improve Quality.
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.
FUNCTIONS:
Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. 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 in Sciences or Master’s degree in Sciences and 3 years of Quality experience or Bachelor’s degree in Sciences and 5 years of Quality experience.
Job Types: Full-time, Contract
Experience:
Quality Assurance: 5 years (Preferred)

Benefits:
None

This Company Describes Its Culture as:
Detail-oriented -- quality and precision-focused
Stable -- traditional, stable, strong processes
People-oriented -- supportive and fairness-focused
Team-oriented -- cooperative and collaborative

Schedule:
Monday to Friday
Day shift
Overtime