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