Posted in Other about 16 hours ago.
Location: West Greenwich, Rhode Island
Location: West Greenwich, RI
Description:
Primary focus is enhancing systems which assures the safety of biologic products. Under general supervision, this position will perform routine procedures and testing in support of the Bioanalytics Team. Main responsibility will be routine release and stability testing. Preferred qualifications will be experience with ELISA, general Chemistry testing such as pH, Osmo, UV and general reagent preparation. The QC Senior Associate will also be responsible for documenting, computing, compiling, interpreting, reviewing, and entering data into electronic systems. Additional responsibilities include providing and communicating results, maintaining/operating specialized equipment, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, GLP, and cGMPs/CFRs which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, building monitoring systems and laboratory log books. Experience with the following GMP systems is also preferred: LIMS, LMES, CIMS and Veeva (cDocs).
Position is located at Rhode Island. Bachelor's degree in Chemistry or Biology & 2 years of experience directly related to the job OR Associate's degree & 4 years of experience directly related to the job.
Basic Qualifications
High school/GED + 4 years work experience or Associate + 2 years work experience or Bachelor + 6 months work experience or Masters Degree
Top 3 Must Have Skill Sets:
ELISA Testing
General Chemistry testing
GMP experience
Must be able to work independently
Bachelor's degree in Chemistry or Biology the preference is to also have industry experience but if they have solid undergrad experience with this testing they would likely still be considered
Day to Day Responsibilities:
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Operate and maintain specialized laboratory equipment and instrumentation
• Participate in laboratory investigations and audits as necessary
• At all times, follow safety guidelines, cGMPs and other applicable regulatory requirements
• Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
• Performs review of procedures, assays, documents and records, including but not limited to deviation records and CAPAs
• Supports Continuous Improvement initiatives, programs and projects
• Alerts management of quality, compliance, supply and safety risks
• Supports internal/external audits and inspections
• Completes assigned training to permit delivery of tasks
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American Cybersystems, Inc.
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American Cybersystems, Inc.
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