Harmans, Maryland
$30.00 - 33.00 An Hour
Quality Assurance Specialist The Principle Group - Harmans, MD Quick Apply Job Details Contract $30 - $33 an hour 2 days ago Qualifications Quality assurance Manufacturing QA/QC Microsoft Excel Microsoft Office Bachelor of Science Bachelor's degree Full Job Description Position Name: Batch Record Reviewer Location: Harmans MD 21077 Position Type: Onsite Shift: Mon - Fri 8 am to 5 pm job description Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Ability to quickly learn new and novel manufacturing processes supporting new clients Able to work in a team setting and independently under minimum supervision Familiarity with electronic systems, including developing and producing reports using Microsoft Office (Excel) Requires the ability to produce results in a fast-paced environment to meet client deadlines Strong technical and quality background related to pharmaceuticals Able to effectively interpret new and existing global regulations Able to communicate effectively with all levels of personnel Intermediate knowledge of Microsoft Office, high organization and record keeping skills required. Clear problem-solving and decision-making skills Ability to be agile, adapt to change, and function well in an evolving environment Education & Previous Experience: A B.S., Life Sciences discipline preferred +4 years' experience within the biologic, biopharmaceutical, pharmaceutical or regulated industry +2 years' experience in a Quality Assurance/Quality Control or Manufacturing function Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish preferred Job Type: Contract Pay: $30.00 - $33.00 per hour Schedule: 8 hour shift Work Location: One location Quick Apply
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