Englewood Lab
Quality Assurance Compliance Specialist - Cosmetics & Skincare
Englewood Lab, Totowa, New Jersey, us, 07512
Quality Assurance Compliance Specialist - Cosmetics & Skincare
Responsibilities
Lead and conduct investigations into failed materials and systems, including product complaints, nonconformities, out of specification results and out of trend quality incidents reporting Review and approve/confirm all new formulas in the Quality Systems Assist with creating and revising Standard Operating Procedures (SOPs) and maintain/update existing SOPs Initiate and review Non-conformance reports, perform Root Cause Analysis and CAPA Maintain Change Control Notices (CC) and implement changes to product specifications for raw materials, bulks, intermediates and finished goods Participate in internal and external audit processes Perform periodic and scheduled audits of Analytical and Micro Lab per Data Integrity requirements Participate in product recall audits Maintain investigation records and associated documents Assist in conducting follow-up on CAPA effectiveness, including close-outs Use the Quality Module within the ERP system to maintain evidence of manufacturing and production investigations supporting current GMP processes Elevate discrepancies to the immediate supervisor for resolution Maintain files of existing specifications for customers and EWL codes Maintain files and database of customer approvals and documents as evidence of authenticity Review customer transmittals (via portals, emails, or faxes) for new or updated raw material specifications Implement changes to specification sheets as approved through proper change control requests Initiate Change Control Requests for customer-requested changes to raw material, intermediates/bulk, finish goods and specifications Initiate investigations, perform root cause analysis and drive implementation of adequate/effective CAPA Maintain copies of approved change controls as applicable to product specification updates/revisions Maintain SOP binders and update them through approved Change Controls Communicate new and updated SOPs to all employees at EWL Ensure that product specification updates are implemented in a timely manner Qualifications
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 Ability to lift and carry up to 10 - 15 pounds Compensation & Benefits
The approximate pay range for this position is $65,000 - $75,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. Medical, Dental, and Vision Insurance Life Insurance 401k match PTO
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Responsibilities
Lead and conduct investigations into failed materials and systems, including product complaints, nonconformities, out of specification results and out of trend quality incidents reporting Review and approve/confirm all new formulas in the Quality Systems Assist with creating and revising Standard Operating Procedures (SOPs) and maintain/update existing SOPs Initiate and review Non-conformance reports, perform Root Cause Analysis and CAPA Maintain Change Control Notices (CC) and implement changes to product specifications for raw materials, bulks, intermediates and finished goods Participate in internal and external audit processes Perform periodic and scheduled audits of Analytical and Micro Lab per Data Integrity requirements Participate in product recall audits Maintain investigation records and associated documents Assist in conducting follow-up on CAPA effectiveness, including close-outs Use the Quality Module within the ERP system to maintain evidence of manufacturing and production investigations supporting current GMP processes Elevate discrepancies to the immediate supervisor for resolution Maintain files of existing specifications for customers and EWL codes Maintain files and database of customer approvals and documents as evidence of authenticity Review customer transmittals (via portals, emails, or faxes) for new or updated raw material specifications Implement changes to specification sheets as approved through proper change control requests Initiate Change Control Requests for customer-requested changes to raw material, intermediates/bulk, finish goods and specifications Initiate investigations, perform root cause analysis and drive implementation of adequate/effective CAPA Maintain copies of approved change controls as applicable to product specification updates/revisions Maintain SOP binders and update them through approved Change Controls Communicate new and updated SOPs to all employees at EWL Ensure that product specification updates are implemented in a timely manner Qualifications
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 Ability to lift and carry up to 10 - 15 pounds Compensation & Benefits
The approximate pay range for this position is $65,000 - $75,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. Medical, Dental, and Vision Insurance Life Insurance 401k match PTO
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