Inspector, Quality Assurance

Overview:

Finished product retention samples processed and recorded into QA logs. Appropriate product AQL performed and release, Hold decisions are made in Trackwise and reported to QA Team Leader.

Responsibilities:

• QA Inspector must conduct audits in Granulation, Blending, Compression, Coating, Boxing and Packaging. QA Inspector is responsible in these departments for performing a daily walkthrough for product verification, SPC verification and product attributes.
• Conduct Line clearance, in-process audits in packaging includes, verification of Packaging line clearance has been completed correctly, verifying that the proper cleaning has been performed by production. After Major “A”or Minor “B” verify that all previous components (with the exception of common components of back-to-back lots) have been removed from the room and approved components are on the line, corresponding to MPS, Master Packaging Specification.
• QA Inspector is responsible to perform all In-Process Inspections checks through Granulation, Compression, Blending (If applicable), Coating, Boxing, and Packaging.
• Perform AQL in Compression, Coating, Boxing and Packaging lines to confirm product is defect free and meets Quality requirements.
• Perform finished product testing in Compression/Coated for weight variation, Friability, Disintegration, pull samples and log into QA Retention logbook (If applicable).
• QA Inspector is responsible to report to QA Team Lead/QA Management Department any Non-Conformance issues which will be addressing by QA Team Lead through TrackWise system.
• QA Inspector is responsible to complete Quality Assurance documents as per QA SOP’s.
• QA Inspector is responsible to make sure product(s) manufactured at IVC-Philadelphia meets all regulatory and cGMP standards.
• QA Inspector is responsible to perform sampling throughout the job required in the workstation area according Batch records requirements.
• QA Inspector is responsible to check all logbooks through manufacturing and Packaging for correct and up to dated entries. QA Inspector must sign off on the bottom on each page once the full page is completed.
• QA Inspector is responsible to verify all entries through electronic logbooks in Granulation and Packaging areas.
• QA Inspector will make sure that every year the logbook is updated and replaced it accordingly.
• QA Inspector is responsible to perform and verify on daily basis the scale and weight logbook accuracy.
• QA Inspector is responsible to complete any IVC training or updated SOPs through “SmartSolve” and “ILearn-Share Point system”.
• QA Inspector/Sampler is responsible for performing Inspections to the Incoming Components and Raw Materials.
• QA Inspector/Sampler is responsible for issuing/returning bottle labels physically and systematically.
• QA Inspector is responsible as business needs, willing to support and work overtime as needed.
• QA Inspector is responsible for other duties as required by Team Leader and /or Management department.

Qualifications:

• High School Diploma or GED.
• 2 to 4 years working experience as a QA in a manufacturing pharmaceutical environmental. Nutritional experience preferred.
• Working knowledge of cGMP, good documentation practice, Trackwise, Oracle will be plus.
• Demonstrate ability to work independently and communicate effectively with a wide variety of individual teams and cross-functional groups.
• Fluent with Microsoft Office (Word, Excel, Outlook).
• Good Documentation skill, both written and verbal.
• Good problem solving and reasoning skill, self-directed. Good Math skills.
• Good attendance, Good Organizational skills and a team player. Experience in Quality system, data entry skill will be a plus.