Chemist C

Aurobindo Pharma; Brassfield (NC); On-site; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical & Rx

Dental

Vision

Life Insurance

Disability

LTD

FSA

HSA

401(k) Plan

EAP

Critical Illness Insurance

Identity Theft Insurance

Paid Time Off

Job summary

Aurolife in North Carolina is seeking a QC Chemist C to perform a variety of testing to assess the strength, identity and purity of test samples and/or materials, with 80–100% bench work and responsibility for reviewing analytical documents and investigations to maintain GLP status.

The role requires a BS or MS in Chemistry or Pharmaceutical Sciences, 5+ years in pharma analytics, and familiarity with inhalation testing is a plus.

Qualifications

• Knowledge of EMPOWER CDS and LIMS.
• QC experience in generic pharmaceutical industries.
• Experience in a cGMP environment is required.
• Knowledge 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.

Responsibilities

• Perform in-process, finished product and stability testing using wet chemicals and instrumental techniques (HPLC, UPLC, GC, UV-Vis, IR, etc.).
• Plan and execute testing to meet timelines with minimal supervision.
• Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs.
• Record data and results per procedures; document work clearly.
• Maintain and calibrate laboratory instruments with minimal supervision.
• Troubleshoot and investigate under supervisor direction.
• Assist in drafting deviation reports as assigned.
• Adhere to regulatory/in-house requirements (safety, GMP/GLP, documentation).
• Review analytical documents.
• Investigate OOS/OOT/Deviation and other events.

Skills

EMPOWER CDS

LIMS

cGMP experience

Good Documentation

USP/ICH knowledge

Team player

Flexible hours

Quick learner

Education

BS/MS in Chemistry/Pharma Sci

Tools

N/A

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 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

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, and maintain the GLP status in lab.

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 finished product methods.
• Independently plan and execute testing to meet established timelines. 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, housekeeping, 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.

Qualifications - Skills & 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.

Education & Experience

• 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.

Benefits

• Medical and Rx Benefits – choice of four medical plans through Horizon. Rx automatically provided with medical benefits.
• Dental Benefits – three dental plan options through CIGNA.
• Vision Plan – two plan options through VSP.
• Life Insurance – Basic Life, 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 $80,000.00/Yr.

Max USD $89,000.00/Yr.

Physical Requirements

• 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.

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.