Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $28.00 – $29.09/hr.
Responsibilities:
- Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Growth promotion testing, TOC & Conductivity testing, sending samples for Microbial ID testing and other micro testing.
- Perform Environmental monitoring of clean rooms including Viables and Non-viables testing and responsible of water samples collection and testing.
- Working knowledge of aseptic techniques and provides database support, generates reports, and analyzes the data as needed.
- Inspection and testing of raw materials, in-process, and final product testing.
- Assist in trending environmental monitoring data. Report and investigate any monitoring excursions.
- Monitors equipment and instrumentation used daily to ensure proper operation and calibration.
- Maintains a working inventory of all components, materials and solutions as needed.
- Develops and revises SOPs & Forms
- Responsible for identifying and alerting supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.
- Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).
- Assists in the writing and updating of Microbiological test procedures, protocol, logbooks, and checklists.
- Assist as needed in test method validation, investigation studies or other product development studies.
- Assist in preparing for and participating in FDA audits, customer audits, etc.
- All other duties as assigned
Qualifications:
- Bachelor’s degree in Microbiology, Biology, or a relevant scientific discipline.
- A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.
- Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.
- Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
- Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques.
- Working knowledge of standard laboratory practices and safety.
- Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
- Experience working in ISO Class 7 & 8 cleanrooms preferred.
Pay Transparency: The typical base pay for this role across the U.S. is: $28.00 – $29.09 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting (url removed).
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