What are the responsibilities and job description for the IPQA Level II 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:
IPQA Associate Level II will support and assist activities related to the production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.
Responsibilities:
Collaborates with other production staff and Departments.
Accurately and consistently completes and documents batch records/other required paperwork.
May provide on the job training and day to day guidance to other nonexempt personnel.
Qualifications - Skills & Requirements:
Good communication skills and capable of communicate with all levels Be able to work long hours to support production requirements.
Be available for overtime, including weekends, as needed for production support.
A familiarity with cGMPS, CFRs, OSHA and FDA regulations.
Education & Experience:
High School Diploma or equivalent GED.
Up to 4 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
Physical Requirements: WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. 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.
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:
IPQA Associate Level II will support and assist activities related to the production of pharmaceutical products in accordance to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.
Responsibilities:
Collaborates with other production staff and Departments.
Accurately and consistently completes and documents batch records/other required paperwork.
May provide on the job training and day to day guidance to other nonexempt personnel.
Qualifications - Skills & Requirements:
Good communication skills and capable of communicate with all levels Be able to work long hours to support production requirements.
Be available for overtime, including weekends, as needed for production support.
A familiarity with cGMPS, CFRs, OSHA and FDA regulations.
Education & Experience:
High School Diploma or equivalent GED.
Up to 4 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
Physical Requirements: WAREHOUSE OR PRODUCTION POSITION – While performing the duties of this job the employee is required to: Regularly lift and/or move objects 10-50lbs Frequently required to stand, walk, stoop, kneel, crouch or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus The worker is subject to environmental conditions. Protection from weather conditions but not necessarily from temperature changes The worker is subject to both environmental conditions. Activities occur inside and outside Medium work Exerting up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects. 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.