QUALITY ASSURANCE ASSOCIATE (WAREHOUSE OPERATIONS)

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.

Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages.

Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

Job Overview:
As Quality Assurance Associate (Warehouse Operations) you will be responsible for QA support of the warehouse and supply chain processes. This role will provide critical quality support to process to ensure compliant receipt, inspection and release of materials used in cGMP manufacturing operations. You will be essential to Quality floor support of the warehouse, aiding the effective resolution of deviations and nonconformances associated with materials, suppliers, and storage.

Responsibilities:

• Support supplier quality management including change notifications and corrective action requests.
• Assist with the onboarding of new GMP materials and suppliers.
• Inspect labels, starting materials and fill/finish components before use in manufacturing.
• Responsible for writing, revising, reviewing and/or approving documents associated with GMP materials such as SOPs, work instructions, and protocols.
• Work cross-functionally to investigate and resolve deviations.
• Execute QA review and approval of master data. Verify chain of custody and complete final release of GMP raw materials.
• Identify and implement continuous improvement activities to eliminate waste and increase the efficiency and effectiveness of Quality oversight.

Qualifications - Skills & Requirements:

• Strong knowledge of GMP regulations and their application.
• Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.

Education & Experience:

• Minimum B.S. degree; preferably in scientific field.
• Minimum 1 year related pharmacuetical quality assurance experience.

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. Additional Physical Requirements:
No Additional Requirements
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.