What are the responsibilities and job description for the IPQA Level III 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 III 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.
Provides on the job training and day to day guidance to other nonexempt personnel.
Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log).
Qualifications - Skills & Requirements:
Communication skills (written and verbal).
Effectively communicate with other department on different levels.
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 decision making.
Education & Experience:
High School Diploma or equivalent GED.
Up to 5 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
Compensation: $28.00 to $32.00 an Hour
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.
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 III 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.
Provides on the job training and day to day guidance to other nonexempt personnel.
Maintaining various logbooks to document the performance or completion of specific functions (ex. Material Receiving Log).
Qualifications - Skills & Requirements:
Communication skills (written and verbal).
Effectively communicate with other department on different levels.
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 decision making.
Education & Experience:
High School Diploma or equivalent GED.
Up to 5 years of experience performing in-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment.
Compensation: $28.00 to $32.00 an Hour
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.
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.
Salary : $28 - $32