18 Quality Compliance Specialist Jobs in Lexington, MA
LanceSoft Inc is Hiring a Quality Compliance Specialist Near Lexington, MA
- Primary duties of the position are focused around non-laboratory support of the QC functions. Primary activities would generally include but not limited to analytical method transfer, analytical method validation, data analysis, data trending, project and testing coordination product and material specification management, inspection support, document authoring, revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
- Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
- Area is focused on data analysis, data trending, project and testing coordination product specification management, LIMS interface, CoA generation,(including interaction with the IT systems such as LIMS that enables electronic management of this activity), and inspection support.
- Area is focused on data analysis and trending of stability data, data reporting, coordination and planning of stability studies, involvement on quality events requiring stability input.
- Area is focused on various technical projects in support of the GMP laboratories, such as automation support, method projects activities (ex. method transfer and validation support activities, method monitoring), critical reagents and reference standard programs.
Responsibilities: Job Function and Description
- % of Time Job Function and Description
- 50-60% data analysis, data trending, project and testing coordination, support of product specification management, COA generation, material specification creation, document revisions.
- 20-30% Regulatory and/or inspection support, method projects activities, initiating/completing quality systems.
- 20% Involvement in other QC activities as required (ex. records retention)
- Experience in Analytical Method Transfer, Analytical Method Validation, HPLC, Bioassays, Client assays, compendial verification, biologics
- Requires a bachelor’s degree and a minimum of 5 years of related experience
- Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask.
- Conducts work in compliance with cGMPs, safety and regulatory requirements.
- Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts, and principles. Position requires critical thinking.
- MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
Job Summary
Full Time
Business Services
$78k-100k (estimate)
06/06/2024
07/04/2024
lancesoft.com
HERNDON, VA
500 - 1,000
2000
Private
DIVYA GANDHI
$200M - $500M
Business Services
Related Companies
About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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