Chemist C

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.

• 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

• 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

• BS or MS in Chemistry or Pharmaceutical Sciences, or related field
• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable
• Preference shall be given for  experience in Inhalation testing on a variety of Inhalation products 

• 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.