Chemist C

Aurobindo Pharma USA, Inc.•Durham, NC

33d•Onsite

About The Position

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. QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. Will work as a member of the stability team to effectively execute QC analytical testing using established (official and/or in-house) test procedures. This role will entail 80% - 100% of their work being performed at the bench level. He will be responsible for review of analytical documents , investigations, maintain the GLP status in lab.

Requirements

Knowledge of EMPOWER Chromatography Data System and LIMS
QC experience in Generic Pharmaceutical industries would be preferable
Experience in a cGMP environment is required
Knowledge and use of Good Documentation practices
Knowledge of USP/ICH/FDA guidelines
Team player who will assist junior colleagues
Willing to work flexible hours to meet product deliverables
Ability to learn quickly and have decision making skills that adhere to regulatory practices is required

Nice To Haves

Preference shall be given for experience in Inhalation testing on a variety of Inhalation products

Responsibilities

Perform assigned in-process, finished product and stability product testing, using various wet chemicals, physical and instrumental techniques ( HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per Finished Product methods.
Independently plan and execute testing to meet established time-lines. Perform complicated testing with little supervisory direction.
Assist with the preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
Perform maintenance and calibrations of laboratory instruments/equipment with little supervisory direction/training.
Perform troubleshooting and investigations under the direction of a supervisor.
Assist in drafting deviation reports as assigned.
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.
Review of analytical documents
Investigation for OOS/OOT/Deviation and other lab related events

Benefits

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