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Acrotech Biopharma inc.

IPQA Level II

Acrotech Biopharma inc., Princeton Junction, New Jersey, United States

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Division Overview Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

AuroPackaging (APK) is a division of Aurobindo USA that plays a primary role in converting the Bulk from our manufacturing sites to Finished Goods (FG) as per requirements. AuroPackaging was founded in 2018 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. The support and expertise of our parent organization has given AuroPackaging a jump start in building a solid pharmaceutical portfolio very quickly. AuroPackaging's aim is to provide healthcare at economical prices to make a healthier world to live in.

Job Overview IPQA Associate Level II will support and assist activities related to the production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.

Responsibilities

Collaborates with other production staff and Departments.

Accurately and consistently completes and documents batch records/other required paperwork.

May provide on the job training and day to day guidance to other nonexempt personnel.

Qualifications – Skills & Requirements

Good communication skills and capable of communicating with all levels.

Be available for overtime, including weekends, as needed for production support.

A familiarity with cGMPS, CFRs, OSHA and FDA regulations.

Education & Experience

High School Diploma or equivalent GED.

Up to 4 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.

Compensation Min: USD $24.00/Hr.

Max: USD $28.00/Hr.

Physical Requirements WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs; Frequently required to stand, walk, stoop, kneel, crouch or crawl; Occasionally required to sit and climb or balance. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus. The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes. The worker is subject to both environmental conditions. Activities occur inside and outside. Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects.

Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.

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