Job Description

• Perform routine and non-routine microbiological assays (bioburden, TOC, endotoxin, conductivity), with increasing complexity, to support critical utility samples, in-process samples, and product release, following established SOPs
• Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
• Assist in the maintenance of laboratory equipment and inventory to ensure smooth laboratory operations
• Ensure data is submitted timely;may qualify as a data reviewer to ensure timely and efficient data availability.
• Perform role-specific operational assignments (e.G., critical utility sampling, environmental monitoring, product testing, etc.).
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with ALNY requirements
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.G., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective company goals
• Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
• Support continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
• Collaborate with other organizational functions including Manufacturing, Materials Management, and Quality Assurance to ensure alignment with overall business goals.
• Support various quality events as needed (i.E., investigations, deviations, CAPAs, change controls)

Qualifications

• B.S. In biology, biochemistry, chemistry, or related scientific field;Associate s degree, Biotech Certificate, or equivalent considered
• Pharmaceutical/Biotech industry experience with 2 years in a regulated laboratory setting, Quality Control, or equivalent, relevant experience
• Demonstrated prior experience/understanding of microbiology testing and EM/CU sampling
• Experience with quality events preferred (i.E., investigations, deviations, CAPAs, change controls)
• Data analysis experience preferred
• Ability to work under direction, with attention to detail, in an environment where priorities shift
• Good communication and teamwork abilities, capable of working effectively in a collaborative environment
• Knowledge of LIMS, Excel, Word, and PowerPoint is helpful

EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.

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