Aurobindo Pharma USA Hiring For Quality Assurance Associate Nc at Durham, NC, United States , United States Full Time

Job Description

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:
QA Associate is to perform all required testing & sampling for Manufacturing and Packaging batches. Perform incoming inspections and outgoing inspections of finished product batches. Perform verifications using special instruments (Caliper, Balance, etc.) to assign final Approval to Labeling, Packaging and Raw Materials.

Responsibilities:
Perform all required testing & sampling of batches in progress and products to be packaged.

Perform line clearances of the manufacturing/ packaging areas and equipment

Verify and confirm issuances and reconciliation of product and components.

Performing Cleaning Verification/Validation Swabbing of Equipment

Verify that temperature/humidity, D.I. Water and Magnehelics are all in range/good working conditionParticipate in Stability/Validation product Sampling

Review and Approve Preventive Maintenance or Work Orders; (if necessary)

Capture critical information for Customer Complaint/Deviation investigations/CAPA/Change Controls (when necessary)

Handle various requests from departments for developmental or investigative reasons

Training of personnel on all pertinent documents and procedures, (including but not limited to their corresponding syllabus) as well as preparing them to become trainers themselves

Data Entry of Finished Product Information into the APR (Annual Product Review) system

Complete all applicable training forms in a timely manner and forward to document control for archival

Qualifications – Skills & Requirements:
Experienced in proper documentation and correction practices

Read, write and speak English

Must be a Team player able to effectively communicate with QA Supervisor, QA, 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

Possess the ability to analyze information and make consistently good decisions

Education & Experience:
Bachelor’s Degree

3+ year experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment

ANY REQUIRED LICENSES/CERTIFICATIONS

A familiarity with cGMPS, CFRs, OSHA and FDA regulations

Experience with deviations/incidents and CAPA

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. We Are An Equal Opportunity Employer: Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.