Chemist C Job South Brunswick area,New Jersey USA,Quality Assurance

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

Chemist-C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist-C will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level. Chemist-C will function as a mentor and assist in training new recruits.

Responsibilities

Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.

Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.

Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.

Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.

Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.

Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.

Perform troubleshooting and investigations under the direction of a supervisor.

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 as required.

Active involvement in training and qualification of newly hired chemists.

Be a role model and mentor to lesser experienced analysts in the team.

Qualifications
- Skills & Requirements

Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
Ability to learn quickly and decision making skills
Attention to detail and documentation
Proficient in working with Empower and LIMS.
2-4 years of experience with handling Out Of Specification investigations.

Education & Experience

Minimum BS within Scientific field
BS with Chemistry is one of the subjects would be preferable
Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing
3 years QC experience in Generic Pharmaceutical industries would be preferable

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

Compensation

Min

USD $85,000.00/Yr.

Max

USD $90,000.00/Yr.

Physica…