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
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).
- Preferred : Experience in the biotech and / or pharmaceutical industry.
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