TekWissen LLC
Location
Provincia di Reggio nell'Emilia | Italy
Job description
Overview :
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Quality Control Chemist
Location: Frederick MD 21704
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Description:
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 inprocess 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:
Bachelors 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 OOSs 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.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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