Aurobindo Pharma USA Hiring For Qc Investigator at Dayton, NJ, 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 product 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 give 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:
As a key site Quality Employee the QC Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible for:

Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.

Assisting SMEs in root cause analysis and trending.

Reviewing and approving CAPAs.

Responsible for the investigation/CAPA SOPs as well as performing training to employees.

Assist QA and Compliance as deemed necessary by the Head of QA.

Responsibilities:
Responsible for completing OOS/ Lab Event / OOT investigation on time.

Qualifications – Skills & Requirements:
Excellent technical writing skills, communication skills, organization skills.

Must be able to speak, read, and write in English.

Education & Experience:
For BS, up to 5 years in a regulated pharmaceutical industry preferably in QA.

For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QA.

Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.

Experience in conducting, writing non-conformance investigations, root cause analyses, and identifying corrective actions.

Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review.

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.