QA Operations Associate Second Shift job in New Brunswick
|Employer:|| Sun Pharma|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
Sun Pharma, one of the world’s largest specialty generic companies, operating in over 150 markets worldwide, has been present in the U.S. since 1996, focusing on generics, branded generics and over-the-counter (OTC) products. We are a vertically integrated company and valued supplier to the largest wholesalers, distributors, warehousing, non-warehousing chain drugstores as well as leading managed care providers.
This position is located at OHM LABORATORIES Inc., (A Sun Pharma Company) in New Brunswick, NJ and is one of the nation’s leading manufacturer of pharmaceuticals. A long standing history of superior product and a steadfast reputation for excellence has positioned OHM LABORATORIES as an integral partner of choice by many leaders in industry. Rigid quality control, quality assurance, versatility, personalized service and the expertise of our team have continually attributed to the success of OHM LABORATORIES Inc. for over two decades.
Position Title: Associate, QA Operations Second Shift
This position is accountable for monitoring and improving compliance at Ohm Laboratories facilities, with specific focus on Manufacturing/Product Development/Technical Services activities such as exhibit/validation and commercial batches and Warehouse operations.
• APR Report generation
• Exhibit batch record review
• Commercial batch record review
• Line clearance, in-process check, AQL
• Understanding of inventory practices Area of Responsibility:
• Conduct Line clearances, in-process checks, AQL
• Monitor compliance in Production, Packaging, Warehouse, and Product Development/Technical Services areas.
• Collection and storage of retain samples
• Collection and submission of stability samples from manufacturing and packaging operations
• Initiating TW deviations
• Batch record review, closure and archival
• Inspect and release printed packaging material, bulk tablets and contract packaged goods
• Provide necessary support to complete Annual Product Review
• Provide necessary support to complete annual retain sample inspection
• Provide supportfor FDA audits (GMP & Pre-approval) and Customer audits through audit readiness preparation, supply necessary documentation, answer queries and other associated tasks
• Provide necessary support to complete DEA inventory
• All other projects or tasks as assigned by supervisor, manager, or department head Minimum of a High School Diploma or GED plus 2 years of Pharmaceutical Industry experience required however an Associate’s Degree with 2 years of Pharmaceutical Industry experience is preferred. Area of Study preferred is Pharmaceutical or related field of study.
• 2+ years Pharmaceutical experience in a QA role and full understanding of cGMP environment
• FDA regulations and GMP guidelines skills
• Manufacturing and packaging operations skills
• Strong communication and written skills
• Document Review Skills
• SAP, Trackwise, LMS, EDMS, DCM, Microsoft Office skills
• Able to multi-task, communicate both verbally and electronically, work in a team environment as well as an individual contributor Work Conditions:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job in an office, lab, or manufacturing environment.
• Corporate office environment
• Manufacturing/Production environment
• Warehouse environment
Environmental related to manufacturing, production and warehouse environments:
• Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
• Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
• Dust: Airborne particles from dispensing, sifting, blending, wood, and silica.
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.
• Bend Flexion of the upper trunk forward while standing and knees extended or knees flexed when sitting.
• Carry to hold or rest weighted objects (maximum weight up to 50 pounds) directly on hands arms, shoulders, or back while walking from one location to another.
• Climb ascend/descend with gradual or continuous progress by one self, using both hands and feet.
• Lift Exertion of physical strength to move objects (up to 50 pounds) from one level to another.
• Push Exertion of force on or against an object (up to 50 pounds) to move it from one location to another.
• Reach Extending the hands and arms in any direction.
• Stoop Flexion of the upper body forward at the waist with partial flexion of the knee while standing.
• 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.