Job Information
Englewood Lab, Inc Quality Assurance Compliance Specialist in Totowa, New Jersey
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