Preferred Qualifications: • Strong knowledge of GMP, SOPs and quality control processes. • Identifying, writing, evaluating, and closing OOS's and investigations. • Proficient in MS Word, Excel, Power Point and other applications. • Strong written and verbal communication skills. • Ability to communicate and work independently with scientific/technical personnel. • Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals. • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
Responsibilities (include but are not limited to): • Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays. • Work with internal and external resources to maintain lab in an optimal state. • Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release. • Maintains laboratory instruments for calibration and routine maintenance • Author or revise SOPs, qualification/validation protocols and reports. • Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures. • Provide updates at daily and weekly meetings. • Monitor the GMP systems currently in place to ensure compliance with documented policies.
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. • Gather metric information for use in continuous improvement of areas of responsibility. • Perform other duties as required.
Basic Qualifications: • Bachelor's Degree OR AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR • High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience