QC Bioassay Analyst

Integrated Resources, Inc

Memphis, TN

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JOB DETAILS

SKILLS

Analysis Skills, Asepsis, Assays, Biological Assay, Biology, Code of Federal Regulations, Communication Skills, Computer Skills, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Analysis, Data Quality, Database Analysis, Detail Oriented, Documentation, GLP (Good Laboratory Practices), Immunology, Instrumentation, Laboratory Operations, Molecular Biology, Organizational Skills, Presentation/Verbal Skills, Quality Assurance, Quality Control, Quality Management, Regulations, Standard Operating Procedures (SOP), Statistics, Team Player, Testing, Time Management, Traceability, Trend Analysis, Writing Skills

LOCATION

Memphis, TN

POSTED

1 day ago

Job Title: QC Bioassay Analyst
Job Location: Memphis, TN
Job Duration: 6 months+ Possible Extension
Shift: Monday through Friday 8:00am to 4:30pm (overtime as needed)

Job summary:
QC Analyst II requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment are essential for success.

Essential duties and responsibilities:

Strong background and experience with cell-based immunological in vitro methods (e.g. MLR, cytotoxicity, HLA-restriction, CTLp, cell proliferation, etc.) and instrumentation.
An understanding of cGMP/GLP regulations as well as excellent documentation skills in order to complete paperwork dealing in all aspects of Quality Control Reviews test results of other QC analysts for accuracy and precision and maintains efficient workflow of an required testing documentation ensuring timely submission relative to product release dates
Study design, data/statistical analysis, reporting results in both written and oral format (presentation)
Enters observations and results into the appropriate trending databases for periodic analysis and trending
Previous experience working with aseptic techniques and culturing of mammalian cells and familiarity with cell culturing basics
Assists the QC Team with maintaining proper overall operation of department (inventories, logs, documentation, filing, etc.)
Assists with implementation of quality improvement initiatives for QC laboratory operations Participates in laboratory, OOS, CAPA, or other investigations, as required
Adheres to Standard Operating Procedures (SOPs) and good documentation practices to ensure data integrity and traceability
Perform all other related duties as assigned.

Qualifications:

Bachelor’s degree in the biological sciences or related field preferred
Minimum 1-2 years of applicable experience in laboratory, biotech, cell therapy, or related industry or a combination of 1-2 years of education and related work experience required.
Previous experience working with aseptic technique and culturing of mammalian cells
Familiarity with cGMP as defined in 21CFR210 and 211.
Detail-oriented with strong written and verbal communication skills
Experience in cell-based assays and molecular biology-based assays
Ability to work independently and as part of a team.

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QC Bioassay Analyst

Integrated Resources, Inc

Memphis, TN

About the Company

Integrated Resources, Inc

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