+ Lead and conduct investigations into failed materials and systems, including product complaints, non conformity, out of specifications and out of trends, quality incidents reporting. + Reviews and approves/confirms all new formulas in the Quality Systems. + Assist with creating and revising of Standard Operating Procedures and maintains/updates existing SOPs. + Initiates, reviews Non- conformance reports, completes Root Cause Analysis and CAPA. + Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods. + Participates in internal and external audit process. + Perform periodic and scheduled audits of Analytical and Micro Lab per Data Integrity requirements. + Participates in product recall audits. + Maintain investigation records and associated documents. + Assist in conducting follow-up to CAPA effectiveness, including close-outs. + Using Quality Module within the ERP system, maintain evidence of manufacturing and production investigation to support current GMP processes. + Brings discrepancies to the attention of immediate supervisor for resolution. + Maintains files of existing specifications for customers and EWL codes. + Maintains files and database of customer-approvals and documents as evidence of authenticity. + Routinely reviews customer transmittal (through customer portals, emails, or facsimile, etc) of new or updated raw material specifications. + Effects changes to specification sheets as approved through proper change control requests. + Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, Finish Goods and specifications. + Initiate Investigations, complete root cause analysis and drive implementation of adequate/effective CAPA + Maintains copies of approved change controls as applicable to product specification updates/revisions. + Maintains SOP binders and updates such through approved Change Controls. + Communicates new and updated SOPs to all employees at EWL. + Ensures that product specification updates are implemented in timely manner. + Any other special projects and duties at the discretion of the immediate supervisor. Requirements + Minimum of 2 years of college + 3 to 5 years industry or related experience. + Previous experience in Pharma, Cosmetics, food, medical device, or allied profession. + Good Technical Writing ability. + Excellent knowledge of Word, Excel, Access, and other Windows-based programs. + Good record-keeping skills. Benefits + Medical, Dental, and Vision Insurance + Life Insurance + 401k match