Chemist C

Acrotech Biopharma Inc; Durham (NC); On-site; USD 80,000 - 89,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision plan

Life Insurance

401(k) Plan

Paid Time Off

Job summary

Aurolife is seeking a QC Chemist C to perform a range of analytical tests to assess strength, identity and purity of samples within the stability team. The role emphasizes bench work (80–100%) and involves review of analytical documents, investigations, and GLP status maintenance.

The ideal candidate has 5+ years in pharmaceutical analytics, experience with cGMP, and familiarity with EMPOWER CDS and LIMS. Flexible hours and teamwork are needed to meet product deliverables in a fast-paced setting.

Qualifications

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

Responsibilities

• Perform in-process, finished product and stability testing using wet chemicals and instrumental techniques (HPLC, UPLC, GC, UV‑Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density) per Finished Product methods.
• Independently plan and execute testing to meet established time-lines with minimal supervision.
• Assist with preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
• Record data and results following documentation procedures; ensure accurate, clear documentation.
• Calibrate and maintain laboratory instruments with limited supervision.
• Assist investigations for OOS/OOT/Deviation under supervisor guidance.
• Draft deviation reports as assigned and ensure compliance with regulatory requirements.

Skills

EMPOWER CDS

LIMS

cGMP experience

GxP documentation

USP/ICH/FDA guidelines

team player

flexible hours

quick learner

Education

BS in Chemistry or Pharmaceutical Sciences

MS in Chemistry or Pharmaceutical Sciences

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. The Chemist C will be responsible for review of analytical documents, investigations, maintaining 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 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, 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 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 $80,000.00 /Yr.

Max: USD $89,000.00 /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.