Manufacturing Operator-NC - Aurobindo Pharma USA, Inc.
Durham, NC 27709
About the Job
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:Mfg./Pkg. Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing & sampling for Manufacturing and Packaging batches. Perform maintenance and troubleshooting of the equipment and machinery. Perform verifications using special instruments (Caliper, Balance, etc.)
Responsibilities:- Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and area.
- Assist all required In-process testing & sampling of batches in progress and products to be packaged.
- Assist Calibration of weighing and required equipment.
- Perform packaging activities.
- Perform other duties as assigned.
- Handle various requests from departments for developmental or investigative reasons.
- Complete all applicable training forms in a timely manner and forward to document control for archival.
Qualifications - Skills & Requirements:
- Familiar with proper documentation and correction practices
- Read, write and speak English
- Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, Warehouse, Engineering and Supply Chain to meet finished product release goals
- Be able to work long hours to support production requirements with flexibility to rotate 1st, 2nd or 3rd shift
- Be available for overtime, including weekends, as needed for production support
- Possess the ability to analyze information and make consistently good decisions
Education & Experience:
- High School Diploma with some college courses, Associates Degree
- 1+ year experience performing Batch Manufacturing and Packing, In-process checks/verifications in the Manufacturing and Packaging areas of pharmaceuticals manufacturing environment
ANY REQUIRED LICENSES/CERTIFICATIONS
- A familiarity with cGMPS, CFRs, OSHA and FDA regulations
- Knowledge of deviations/incidents and CAPA