What are the responsibilities and job description for the QA Documentation Associate position at Aurobindo Pharma USA, Inc.?
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
The QA Documentation Associate will be responsible for QA documentation related to batch record issuance, reconciliation of documents, issuance of control documents, and maintenance of company-wide training record files for each employee.
Responsibilities
Maintain the Manufacturing and Packaging Batch Record Master hard copy and pdf soft copy. Create and maintain the New Hire Employee Training Folders. Help in the GMP training of New Hire Employees. Assist in QA documentation activities as and when required. Maintain the Change Control Spreadsheet and documentation related to Change Control.
Qualifications - Skills & Requirements
Good knowledge of Microsoft Office Applications.
Education & Experience
Bachelors Degree required.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
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., Good knowledge of Microsoft Office Applications., Maintain the Manufacturing and Packaging Batch Record Master hard copy and pdf soft copy. Create and maintain the New Hire Employee Training Folders. Help in the GMP training of New Hire Employees. Assist in QA documentation activities as and when required. Maintain the Change Control Spreadsheet and documentation related to Change Control.
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
The QA Documentation Associate will be responsible for QA documentation related to batch record issuance, reconciliation of documents, issuance of control documents, and maintenance of company-wide training record files for each employee.
Responsibilities
Maintain the Manufacturing and Packaging Batch Record Master hard copy and pdf soft copy. Create and maintain the New Hire Employee Training Folders. Help in the GMP training of New Hire Employees. Assist in QA documentation activities as and when required. Maintain the Change Control Spreadsheet and documentation related to Change Control.
Qualifications - Skills & Requirements
Good knowledge of Microsoft Office Applications.
Education & Experience
Bachelors Degree required.
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
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., Good knowledge of Microsoft Office Applications., Maintain the Manufacturing and Packaging Batch Record Master hard copy and pdf soft copy. Create and maintain the New Hire Employee Training Folders. Help in the GMP training of New Hire Employees. Assist in QA documentation activities as and when required. Maintain the Change Control Spreadsheet and documentation related to Change Control.
