Quality Assurance Compliance Specialist
Englewood Lab, Inc
Totowa, new jersey
Job Details
Not Specified
Full Job Description
- 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