QC Documentation Associate - 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 QC Documentation Associate will be responsible for the activities related to QC Documentation, sample management for finished product and stability testing and sending samples to outside labs for testing. 

Responsibilities:

• Perform sample log-in activity and organize the incoming samples for testing.
• Co-ordinate to load and pull the stability samples from the chambers.
• Periodically check for the expired chemicals and separate them for destruction.
• Send samples to third party labs for Micro testing.
• Organize the Laboratory related documents and maintain/submit the documentation to QA for archival as and when required.
• Receive and load the stability samples into the respective stability chambers as defined in the Approved Protocols.
• Prepare the stability sample pull schedules, Pull the samples at the respective time intervals and submit to the sample login in-charge and notify to the concern team leads. Circulate the monthly stability schedule to the team leads.
• Any changes in stability schedule/any discontinue in stability program need to coordinate with the team leads and circulate the respective document for approval.
• Remove the additional/retain samples from the stability chambers during the last time point pull and discard the samples appropriately.
  For control substance stability samples inventory should be maintain throughout the stability program.
• Periodically review and update the stability SOP’s and related documents to in line with the current ICH guidelines.
• Maintain the Working standards/Reference standards/Impurities/sample inventory which required for analysis.
• Place the lab chemicals, standards and consumable orders as and when required.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.

Qualifications - Skills & Requirements:

• Ability to learn quickly.
• Good knowledge of Microsoft Office Application.

Education & Experience:

• Minimum Bachelor's degree in relevant field (Chemistry preferred).

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: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.