Quality Assurance - Quality Systems Engineer

Englewood Lab, Inc.•Totowa, NJ

1d•Onsite

About The Position

The Quality Systems Engineer will perform Process Validation and Cleaning & Sanitization Validation under quality systems to ensure compliance. They will maintain formal drug stability programs, bulk hold studies, product compatibility, SOP binders, supplier and vendor qualification programs, and participate in IQOQ including Risk Assessment of Quality Systems. This role is responsible for supporting the company's business events through a variety of tasks.

Requirements

Associate’s degree (2-year college degree) required.
Good Technical Writing ability.
Excellent knowledge of Word, Excel, Access, and other Windows-based programs.
Good record-keeping skills.

Nice To Haves

Previous experience in Pharma, Cosmetics, food, medical device, or allied profession preferred.
Knowledge of FDA Regulations under FD&C Act is a plus.

Responsibilities

Reviews and approves/confirms all new formulas in the Quality Systems.
Design and author protocols and reports to support qualifications, validation and designs of experiments.
Perform capability analysis and trending to support validation and qualifications.
Co-ordinates process validation and product stability programs and maintain associated reports.
Conducts Annual Drug Reviews and Device History Reviews.
Maintains regulatory documents and all documents of external origin.
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.
Participates in product recall audits.
Complies with 21 CFR Part 210, 211 & 820.
Perform other duties as assigned by the manager.
Perform Process Validation and Cleaning & Sanitization Validation under the quality systems to ensure compliance.
Maintains formal drug stability program, bulk hold studies, and product compatibility by coordinating samples submission, testing, result retrieval and program review.
Maintains files and database of customer-approvals and documents as evidence of authenticity.
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, FGs, specifications.
Maintains copies of approved change controls as applicable to product specification updates/revisions.
Maintains SOP binders and updates such through approved CCs.
Communicates new and updated SOPs to all employees at EWL.
Maintain suppliers and vendors qualification program.
Participate in IQOQ including Risk Assessment of Quality Systems.
Perform annual drug and device history reviews.
Any other special projects and duties at the discretion of the immediate supervisor.