What are the responsibilities and job description for the Quality Assurance Compliance Specialist - Cosmetics & Skincare position at Englewood Lab?
Title: Quality Assurance Compliance Specialist
Reports to: Quality Systems Manager
Department: Quality
Responsibilities:
S3SI7VZLtD
Reports to: Quality Systems Manager
Department: Quality
Responsibilities:
- 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
- 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
- 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. The benefit package includes:
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
- PTO
S3SI7VZLtD
Salary : $65,000 - $75,000