In-Process QA Inspector (Second Shift) job

Sun Pharma
Job Location
Cranbury, NJ
Job Description

In-Process QA Inspector (Second Shift) -- IPQA (Second Shift Hours -- 3:30 p.m. - 12:00 a.m.) 
The world’s largest pharmaceuticals market is also the biggest market for Sun Pharma. We have been present in the US since 1996, working with the country’s healthcare system with a focus on generics, branded generics and over-the-counter (OTC) products. We are valued suppliers to the largest wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers. Being a vertically integrated company with a global presence, we have the flexibility to develop and manufacture products in the US as well as at other locations across the world. Our US headquarters is located in Cranbury, New Jersey and we have manufacturing, distribution and customer service teams at multiple locations across the country. 
Very Important Note: This person hired for this position will initially start working on first shift (7:30 a.m. - 4:00 p.m.) for training purposes and then transition to working second shift hours (3:30 p.m. - 12:00 a.m.) once the initial training phase is completed. 
Job Summary: 
This role verifies and line clearance for dispensing, manufacturing and packaging activity. Perform batch record review, random sampling and in-process testing and final AQL visual inspection of finished bulk product. Performs manufacturing and packaging record review, random sampling and in-process testing, and final AQL inspection of packaged finished product. 
Essential Job Functions: 
Verify dispensing activity and review of pharmacy stage BMR. 
Verify the cleanliness of rooms and equipment, and perform line clearance activity in the manufacturing and packaging areas. 
Verify manufacturing activity and review of manufacturing BMR at granulation/compression/coating/encapsulation end stage. 
Blend sampling using sampling thief 
Online BMR review and random sampling and performs in process tests. 
AQL visual inspection of finished bulk product and collect samples for QA testing. 
Ensure manufacturing area, log books, utility systems are compliant per GMP and in-house procedures. 
Review and release the batch for packaging process. 
Perform in-process checks for packaging activity 
Review packaging batch record review. 
Collect and compile data for Annual Product Review. 
Maintain QA hold log book. 
Collect retain samples and stability samples. 
Maintain and perform annual visual inspection of retain samples. 
Perform activities related to receipt, storage, inspection, and issuance of labeling components. 
Affix/remove QA disposition labels on the drug product containers. 
Additional duties as assigned by the supervisor.

High school diploma minimally, BS degree in Science preferred. 
At least 1 - 2 years of pharmaceutical industry experience is required. 
Knowledge of packaging operations and/or label inspection preferred. 
Excellent writing skills are required. 
Must have the ability to work overtime hours including occasional weekends. 
Physical Requirements: 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend. 
Capable of bending and lifting and/or moving approximately 50 - 75 pounds on a regular basis. 
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes. 
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes. 
Must have English language fluency, both written and verbal, with the ability to communicate at all levels within the organization. 

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