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Chemist B
- Durham, North Carolina, United States
- Durham, North Carolina, United States
À propos
Division Overview
Aurolife Pharma 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 Pharma 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 Pharma a jump start in building a solid pharmaceutical portfolio. The Aurolife family consists of an experienced management team with expertise in Manufacturing, R&D, Quality Assurance, Quality Control and Regulatory Affairs. In addition to several formulations in our product portfolio, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make a healthier world.
Job Overview
To perform assigned testing of topical, transdermal and Inhalation products in various stages of manufacturing using wet chemistry, physical and instrumental techniques. The chemist may execute 90% - 100% of their work at the bench.
Responsibilities
QC Chemist B 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 team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The QC Chemist B may execute 90% - 100% of their work at the bench level.
- 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, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
- Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
- Work with supervisor to 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/equipment with supervisory direction/training as needed.
- 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
Qualifications - Skills & Requirements
- BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
- Minimum 5-10 years of experience in pharmaceuticals and must have 5 + years of experience in Analytical testing
- 5+ years QC experience in Generic Pharmaceutical industries would be preferable
- Experience in a cGMP environment is required
- Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable
- Knowledge and use of Good Documentation practices
- Knowledge of USP/ICH/FDA guidelines
- Ability to learn quickly and having decision making skills
Education & Experience
- BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
Compensation
Min
USD $60,000.00/Yr.
Max
USD $70,000.00/Yr.
Benefits
Annual Bonus
- 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
Compétences linguistiques
- English
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