Quality Control Analyst

Job Responsibilities

• Perform routine analytical testing including but not limited to cell-based potency assays, ddPCR, qPCR, ELISAs, quantitative or limits testing using HPLC techniques
• Prepares laboratory solutions, maintains cell lines, maintain inventory of materials, and other day to day laboratory activities
• Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data in a GMP manner
• Affixes to revisions of work instructions, SOPs, forms, reports, and electronic laboratorynotebook analytical records
• Affixes to management of analytical test method supplies and samples as needed
• Ensures lab areas are clean, organized, maintain equipment and consumables
• Works closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments
• Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external
• Supports revisions to work instructions, SOPs, forms, protocols, and reports

Minimum Requirements

• Bachelor’s degree in biology or related field
• Excellent verbal and written communication skills
• Ability to handle multiple projects/teams simultaneously based on general instruction
• Ability to work independently in a fast-paced, highly interactive environment
• Ability to build open and collaborative relationships and work effectively as a member of the QC department

Preferred Education, Experience And Skills

• Relevant work experience in cGMP regulated Quality Control laboratory within the pharmaceutical or biotech industry or related field
• GDP experience preferred
• Experience with cell-based assays and PCR testing is preferred
• Experience working within a cGMP Quality Control LIMS system preferred