Quality Assurance / Control Inspector 8/20/2016

Open Systems Technologies Hauppauge, NY

Company
Open Systems Technologies
Job Classification
Full Time
Company Ref #
28890349
AJE Ref #
575946425
Location
Hauppauge, NY
Job Type
Regular

JOB DESCRIPTION

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A pharmaceutical company is seeking Quality Control/Assurance personnel for their Long Island facilities. Main responsibilities include packaging pharmaceutical products following all SOPs and GMPs. The right candidate should have prior quality experience.

The QA Floor Inspector provides review of in-process test data and batch documentation in order to limit the need for later review or rework. The QA Floor Inspector is the Quality expert on the production floor and will guide and advise operations associates as necessary on cGMP's and Good Documentation Practices to ensure timely release of product or reaction to issues.

Responsibilities include:

Record data manually and on computer

* Investigate discrepancies or adjust errors.
* When required, conduct approval of pre-start-up activities including line/room clearance, and initial equipment checks.
* When required, perform in-process testing verifications of operations data to confirm consistency in testing methodology and test data.
* Consistently review in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP's and cGMP's.
* Discusses errors directly with line personnel so corrections can be made if required.
* Collect data on FPQ and performs release of batch records.
* Perform daily compliance Audit for responsible areas within production.
* Responsible for conducting duties in compliance with safety rules, applicable SOP's, and cGMP Guidelines.
* Experience with production equipment functionality and Quality Assurance Systems is preferred.
* Experience working with computer software such as AS400, Captiva and PDM software is preferred.
* Work environment may be exposed to powders, chemicals and allergens

Requirements include:

High organizational skills, required.

High attention to detail is required.

Excellent written and oral interpersonal communication skills, required.

Intermediate to advanced computer knowledge of MS Office programs (Outlook, Excel, and Word) is required.

Physical ability to repetitively lift (up to 50 lbs.), stand, bend, climb, etc. within an operatiOns environment is required.

High school diploma or general education degree (GED) is required.

Complies with company policies and procedures and maintains exceptional work attendance.

Understanding of mathematical functions, such as mean, median, average, and standard deviation is preferred.