QC Technical Specialist

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

Serve as technical expert on Quality Control instrumentation and methods. Train and mentor junior chemists. Troubleshoot technical issues and participate in root cause analysis for laboratory investigations. Prepare and review analytical methods and SOPs. Perform assigned testing on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques when required.

Responsibilities

Responsibilities:

1. Serve as technical expert for a variety of instrumentation including but not limited to HPLC, GC, Dissolution, UV, IR
2. Train other chemists on a variety of instruments and analytical methods
3. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
4. Perform troubleshooting and investigations
5. Review of Analytical documents as required.
6. Perform maintenance and calibrations of laboratory instruments/equipment
7. Perform assigned testing on raw materials, active pharmaceutical ingredients, in-process, finished and stability products as needed.
8. Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.

Qualifications - Skills & Requirements

Experience in HPLC, GC & Dissolution required. Empower 3 experience preferred. Prior experience of both raw material and finished product testing. Experience in Generic Pharmaceutical industries is preferable • Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA • Ability to learn quickly, solve problems and train effectively

Education & Experience

Minimum BS with Scientific field, Chemistry preferable • Minimum 10-15 years of experience in pharmaceuticals and must have at least 7 years of experience in Chromatography

Compensation: $80,000 to $90,000 Annual Bonus

• 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.

Compensation
Min

USD $90,000.00/Yr.
Max

USD $100,000.00/Yr.
Physical Requirements

LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. • Must practice good personal hygiene • Must be able to lift up to 25 lbs. • Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. • Position requires working in the laboratory as well as sitting
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.