IT QA Analyst

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 give 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

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.

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.

Qualifications - Skills & Requirements

• 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.

Compensation: $30.00 hour to $50.00 hour, Annual Bonus

• 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

Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.

Education & Experience

• High School Diploma.
• Up to 3 years experience in required in-process checks/verifications for both manufacturing and packaging.

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time 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 III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.