Chemist B

Aurobindo Pharma USA, Inc.

Durham, North Carolina

JOB DETAILS
JOB TYPE
Full-time
SKILLS
Active Pharmaceutical Ingredient (API), Analysis Skills, Biotech and Pharmaceutical, Chemistry, Copying Machines, Corrective Action, Current Good Manufacturing Practice (cGMP), Dental Insurance, Depth Perception, Detail Oriented, Documentation, Drug Development, Employee Assistance Plan, Equal Employment Opportunity (EEO), Equipment Maintenance/Repair, Flexible Spending Accounts, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Genetics, Health Economics, Health Plan, Healthcare, High Performance Liquid Chromatography (HPLC), IR (Infrared), Identify Issues, Insurance, Laboratory Analysis, Laboratory Equipment, Laboratory Testing, Maintain Compliance, Manufacturing, Materials Testing, Office Equipment, Order Supplies, Physical Chemistry, Physical Demands, Prescription Drugs, Product Development, Quality Assurance, Quality Control, Quality Metrics, Recruiting/Staffing Agency, Regulations, Regulatory Compliance, Regulatory Requirements, Research & Development (R&D), Risk, Standard Operating Procedures (SOP), State Laws and Regulations, Testing, Titration, UV/VIS (Ultraviolet-Visible Spectroscopy), Vision Plan, Willing to Travel
LOCATION
Durham, North Carolina
POSTED
1 day ago
Division Overview:

Aurolife PharmaLLC logo

 

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 B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation. They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), Standard test procedure and Good Manufacturing Practices (GMP). QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines. This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.

 
 

 

Responsibilities:
  1. Perform physical, chemical and instrumental tests 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 2-4 year 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:
  • Minimum BS with Scientific field 
  • BS with Chemistry is one of the subjects preferred

  • 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.

Physical Requirements: FIELD - While performing the duties of this job the employee is required to: •Work in a temperature controlled office environment or travel via vehicle or commercial transportation •While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment •Position requires some degree of travel for business purposes •Employee may use computer, phone, copier and other office equipment in the course of a day •Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 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. 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.

About the Company

A

Aurobindo Pharma USA, Inc.

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients.  Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes.  Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages. 

Aurobindo markets over 80% of the top 100 most prescribed products in the world.  In past years, Aurobindo has received more ANDA approvals than any of our competitors.  Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

COMPANY SIZE
1,000 to 1,499 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.aurobindousa.com/