Chemist B, Quality Control Position Available In Durham, North Carolina

Chemist B, Quality Control Aurobindo Pharma USA, Inc.

Durham, NC Job Details Full-time Estimated:

$59.7K

• $74K a year 1 hour ago Qualifications Management Bachelor of Science Laboratory experience Mid-level Bachelor’s degree Manufacturing Research & development FDA regulations 10 years

Full 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 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:

Support the Inhalation Team within the QC Department at Aurolife Unit-2 by performing physical and analytical determinations to characterize metered dose inhaler products in our portfolio. DDU/SAC (delivered dose uniformity/single actuation collection) ASPD by NGI (aerodynamic particle size distribution by next generation impactor), total content assay, degradation products, moisture, dose counter accuracy, total number of actuations, foreign particulates, and spray pattern are examples. Prepare Certificates of Analysis (CoAs), data tables, and trend tables for review and approval.

Responsibilities:

1. 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. 2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work. 3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction. 4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately. 5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned. 6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training. 7. Perform troubleshooting and investigations under the direction of a supervisor. 8. 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. 9. Review of Analytical documents as required Qualifications

• Skills & Requirements:

  Minimum 3-5 years experience in pharmaceuticals and must have 3-4 years experience in Analytical testing

• Experience in Generic Pharmaceutical industries would be preferable
• Knowledge in Good Documentation practices.

Knowledge in

USP/ICH/FDA

• Ability to learn quickly and decision-making skills .

Education & Experience:

BS in the scientific field, chemistry is preferred, with 3-4 years of experience in a regulated analytical laboratory.

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:

Hand Manipulation is required

• Fine Manipulation Left Hand Hand Manipulation is required
• Fine Manipulation Right Hand Hand Manipulation is required
• Pushing & Pulling Left Hand Hand Manipulation is required
• Pushing & Pulling Right Hand Hand Manipulation is required
• Simple Grasping Left Hand Hand Manipulation is required
• Simple Grasping Right Hand Standing 1-4 Hours Sitting 1-4

Hours 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.

We Are An Equal Opportunity Employer:

Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.