QC Chemist - Pharma Manufacturing

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 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
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.
Additional Physical Requirements
No Additional Requirements

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.