Chemist C

Division Overview Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct 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 managementteam with expertise in manufacturing, R&D, Quality Assurance and Qualitycontrol 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 Responsible for ensuring compliance with Good Laboratory Practices (GLP), cGMP requirements, and internal quality standards within the Quality Control laboratory. Oversees laboratory compliance activities, including review of analytical documentation, data integrity verification, laboratory audits, investigations (OOS/OOT/Deviations), CAPA management, and regulatory inspection readiness. Supports the implementation and continuous improvement of quality systems,analysis of analytical samples (RM/PM/SFG/FG/Stability ) Responsibilities Ensure compliance with Good Laboratory Practices (GLP), cGMP, Data Integrity, and applicable regulatory requirements. Review and maintain laboratory documentation, including analytical worksheets, logbooks, instrument usage records and Audit trail of different software. Perform periodic laboratory audits and identify gaps related to GLP compliance. Support/perform investigations related to OOS, OOT, Deviations and CAPA Review analytical data for completeness, accuracy, and compliance with ALCOA+ principles. Manage laboratory documentation systems and ensure timely archival and retrieval of records. Participate in preparation and support of regulatory inspections, customer audits, and internal audits. Review laboratory equipment qualification, calibration, and maintenance records for compliance. Monitor laboratory housekeeping and maintain compliance status of laboratory areas. Track and trend laboratory compliance metrics and prepare periodic quality reports. Collaborate with QA, QC, Manufacturing, and Regulatory Affairs to ensure regulatory compliance. Ensure timely closure of investigations, CAPAs, and change controls related to laboratory activities. Review and approve laboratory documents, protocols, reports, and compliance assessments as assigned. Analysis of RM/PM/SFG/FG/stability samples Perform the calibration of Laboratory instrument Management of Primary and seconday standard in Laboratory. Qualifications - Skills & Requirements Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing 3 years QC experience in Generic Pharmaceutical industries would be preferable Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA Ability to learn quickly and decision making skills Education & Experience Minimum BS with Scientific field BS with Chemistry is one of the subjects would be preferable 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 $80,000.00/Yr. Max USD $90,000.00/Yr. Physical Requirements FIELD - While performing the duties of this job the employee is required to: Work in a temperature controlled office environment or travel via vehicle or commercial transportation While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment Position requires some degree of travel for business purposes Employee may use computer, phone, copier and other office equipment in the course of a day Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Blood/Fluid Exposure Risk Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks. #J-18808-Ljbffr