IPQA Level I
Aurobindo Pharma USA, Inc.
Division Overview Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in. Job Overview IPQA Associate Level I will support and assist the day to day activities related to the cleaning and documenting of sampling designated areas, Sampling of incoming raw materials, packaging and labeling material, water sampling, CV sampling, completion of appropriate documentation, registering in LIMS, deduction of sampling quantity in ERP, promptly subbission of the collected samples to the QC lab, further supporting to production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate Level I shall assure compliance with all standards and regulatory guidelines. Responsibilities Collaborates with other production/warehouse staff and other Departments. Accurately and consistently completes and documents batch records/other required paperwork. Maintaining various logbooks to document the performance or completion of specific functions. Replace Temperature/Humidity Charts weekly. Maintaining IPQA supply inventory. Qualifications - Skills & Requirements Ability and willingness to learn manufacturing/packaging procedures and federal regulations pertaining to manufacturing process. Experienced in proper documentation and correction practices. Read, write and speak English. Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals. Be able to work long hours to support production requirements. Be available for overtime, including weekends, as needed for production support. Education & Experience High School Diploma or Equivalency. Up to 2 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment. Compensation: $22.00 to $24.00 an hour. Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits Dental Benefits with three dental plan options through CIGNA Vision Plan with two plan options through VSP Life Insurance, Basic Life and AD&D and Supplemental Life Insurance Disability Insurance, Voluntary Short-Term Disability and State Disability • Long-Term Disability (LTD), State (short term) disability – where applicable FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available HSA (Health Savings Account) 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years Employee Assistance Program (EAP) - 100% Confidential and 100% company paid Critical Illness and Accidental Insurance Legal and Identity Theft Insurance Paid Time Off - Paid vacation, PTO, Holiday Compensation Min USD $22.00/Hr. Max USD $24.00/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. 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.
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