Quality Assurance Compliance Specialist

• 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

Last updated on Jun 7, 2024