QA Compliance Lead

QA Compliance Lead Participating in the development and maintenance of quality systems, processes and procedures to assure product quality and safety. Assisting the quality assurance site manager in preparation for internal/external audits and implementation of corrective actions to address non-conformities. Supporting risk management process throughout the product life cycle and providing senior management with key data from RA to help drive decisions. Supporting, development and maintenance of product approval/clearance/licensing documentation and notifications as required by global regulatory agencies. Assist in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility. Communicates and implements a strategy to ensure compliance. Responsible for review of batch records in support of disposition of bulk drug substance. Responsible for review of equipment validation protocols and report. General compliance quality systems management support for the following areas: Raw material and solution release. Review of raw material specifications and solution docs. Release of single use disposable product to include label reconciliation. Review of temp. charts and docs or temp related excursions. Review and update label issuance and reconciliation process. General QA documentation support to include the following: Issuance of batch records and issuance and tracking of log books, lab notebooks and SOP binders. Scanning and filing of excursion docs and client related batch docs to support batch release. Develops process improvement plans using a variety of quality and continuous process improvement tools, including but not limited to Six Sigma, Lean Manufacturing, SS, SPC, engineering studies, DOE Gauge R&R, etc. BA degree or a min. of 5yrs work exp. 3 years exp working in a regulated industry. Demonstrated understanding or aptitude to understand drug or Pharma QMS requirements and regulatory requirements including but not limited to FDA, CFR 21 210 and 211. Demonstrated exp. and proficiency with MS Office, word processing, spreadsheet(Excel), presentation and database applications. Integrated Resources