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 managementteam with expertise in manufacturing, R, Quality Assurance and Qualitycontrol 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.
The Microbiologist will be responsible for performing microbiological testing of cGMP controlled areas, pharmaceutical grade water, and in-process materials in compliance with cGMP, GLP, USP, guidelines and SOPs.The Microbiology may execute 90% - 100% of their work at the bench level.
Preparation of SOP and ensuring of their implementation.Provide microbiological sampling, testing, and monitoring to assure quality of materials, components, in-process products, finished products, and retained/stability samples, including: a.Media Preparations b. Plate Observations c. Colony identification d. Isolate Library e. Culture Prep and Maintenance f. BET testing g. Sterility testing h. Growth promotion testing (GPT) i. Water / Bioburden testing / MLT / Identification for Microorganisms. j. Environmental Monitoring / Cleaning / Validation, etc.Preparation of Microbiological method development and method validation procedures like BET Sterility, MLT, BIO Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation.Microbiological data Review, summary preparation (trend data, text reports and validation data) and Approval of documents and Procedures.Report, investigate, and resolve any QMS incidents in the process, system, facility or documents associated with non-conformances related to the microbiological aspects such as sterility, bioburden, endotoxin, environmental monitoring, etcProcurement of Laboratory needs (Laboratory Indent) and qualification of vendors.Preparation of validation Protocols and Execution of the same.Involvement and execution of process simulation studies (Aseptic media fill).To ensure the process of Technology Transfer Dossier (TTD) acceptance to the plant and to work out the manufacturing and availability of the product without delays.Schedule training and qualification of production personnel and their record maintenance.Handling of OS and OOT.Implementation of QMS (Change Management and deviation management in coordination with QA department.Execution of equipment and area qualifications.Internal inspection for audit compliance.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.
Qualifications - Skills & Requirements:
Must possess proven understanding of SOPs and cGMP guidelines and regulations. Aseptic gowning certification desiredMust possess excellent communication (oral and written), organizational, and interpersonal skills.Detail oriented with strong aseptic techniques and documentation skills.Ability to follow SOPs and cGMP guidelines and regulations is required.Must be able to work in a team environment and perform job responsibilities under minimal supervision.Must be proficient with MS Office applications.
Education & Experience:
Minimum Bachelors degree in microbiology, Up to 5 years of related lab experience; or equivalent combination of education and experience.
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:
Lifting 1-4 Hours - 30+ Pounds
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.