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Aurobindo Pharma USA, Inc. · 3 months ago

IT QA Analyst

Durham, North Carolina

Full-time

Onsite

New Grad, Entry Level

$30/hr - $50/hr

0+ years exp

Aurobindo Pharma USA, Inc. is a company with a strong background in generic pharmaceutical product development and manufacturing. They are seeking an IT QA Analyst to coordinate production priorities, review batch records, and assist in quality assurance functions to ensure the timely release of products.

BiotechnologyPharmaceutical

No H1B

U.S. Citizen Only

Responsibilities

Coordinate production priorities

Review IPQA entries in batch records on the floor

Assist in batch review

Coordinate printed packaging material release

Coordinate annual CV program

Assist in APR entry/ approval

Review and approve COA in LIMS

Order supplies in Oracle

Collect / review water room forms

Qualification

In-Process Quality AssurancePharmaceutical manufacturing experienceCGMP familiarityCleaning Verification/ValidationEnglish fluencyEffective communicationTeam playerDecision making

Required

Must complete all proper training forms for the applicable responsibilities listed below and contained within the position's specific syllabus

Be able to train other IPQA as necessary per their syllabus and complete the trainer portion of the documentation

Must be a Team player able to effectively communicate with the fellow IPQA, Quality Control, Production and Supply Chain to meet finished product release goals

Be able to perform all IPQA (In-Process Quality Assurance) functions during IPQA absences

Must be able to read, write and speak fluently in English

Ability to effectively communicate orally and in writing

Be able to work long hours to support production requirements

Be available for overtime including weekends

Be a permanent resident or citizen of the U.S

Be experienced in a pharmaceutical manufacturing/packaging environment

Ability to analyze information and make consistently good decisions

Must be able to perform Cleaning Verification/ Validation swabbing

A familiarity with cGMPS, CFRs and FDA regulations

High School Diploma

Up to 3 years experience in required in-process checks/verifications for both manufacturing and packaging

Benefits

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