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Perform entry level testing within the QC Lab. Scope includes retain inspections, entry level /microbiological testing and utility sampling.
Perform routine laboratory tasks such as Utility/EM sample collections, execution of equipment work orders,, reading of environmental monitoring samples, bioburden testing, level one audits, daily pH meter and balance calibration, etc. Perform tasks associated with ordering laboratory supplies and maintaining laboratory equipment. Author SOPs and deviations.
Follow and work in accordance with company policies, SOPs and cGMP standards to ensure compliance with all applicable regulations. Identify atypical events or potential problems and communicate these situations with appropriate personnel.
• Perform utility sampling as per established procedures. Perform associated sample reads/testing.
• Generate all paperwork and labels associated with sampling to meet SOP requirements. Collect PEMS data.
• Perform EM sampling reading and microbiological tests in compliance with current SOPs and GMPs. All testing must be completed to satisfy established timelines and all applicable regulations.
• Author deviations and SOPs.
• Responsible for maintaining and ordering sufficient reagents and supplies, ordering equipment and maintaining the equipment in good working conditions in a calibrated and validated status. Performing routine laboratory tasks such as safety shower/eyewash checks, autoclaving materials, performing glass-wash and stocking supplies, daily pH meter and balance calibration, etc. Ensure labs are in a ‘GMP, safe, analytical-testing readiness’ state.
• Assure that all required documentation including records and logs, is complete and accurate according to the current GMPs. File and archive laboratory records and data in accordance with GMPs and SOPs.
• Communicate and report status of operations as well as variances to supervisors. Take appropriate actions and escalate issues immediately.
• High school degree; Assoc. or B.S. preferred
• Prefer two years GMP laboratory experience (microbiology) or Assoc. or B.S. with minimum of one year GxP experience
• Computer skills required in Excel and Word.
• Ability to follow written procedures and document results in a neat and precise manner.
• Proficient with SAP.
• Must be well organized, flexible, open-minded and dynamic.
• Must have demonstrated self-direct work habits and strong communication skills.
• Must be a committed team player prepared to work in and embrace a team based culture.
• Ability to work within a multi-skilled team.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.
• Position may require employees to work in a rotational schedule. This schedule will include participation in a non-routine business hour rotation to cover utility sampling collection on evening and weekends. This will require being on-call approximately one weekend a month. Some over-time may be required.
• Some experience in analytical systems including quality control, validation, documentation and compliance preferred.
• Strong interpersonal skills. Solid team player able to function within team based organization.
• Able to interact with peers, subordinates and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production and QA.
• Able to prioritize and decide appropriate course of actions.
• Ability to understand client’s needs (producers) and to interact with people from various domains (Regulatory, QA, other analytical groups inside the Company.)
• Demonstrated ability to perform all job duties with limited supervision.
• Demonstrated familiarity with cGMP’s, facility regulatory guidelines and standard operating procedures.
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About LanceSoft Inc
Lancesoft is one of fastest growing and largest clinical staffing firm in the U.S. and an employer-of-choice for over 1000+ consultants - this may be your opportunity to join us!
We recruit top-notch talent for Healthcare, Pharmaceutical, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking/ Finance, Manufacturing, Automobile, Media, Transportation, and Government clients coast-to-coast across the US, Canada and India. We are one of the fastest-growing companies in the industry and
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Click here to visit our website - www.lancesoft.com
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