What are the responsibilities and job description for the Quality Control Chemist - I position at Sharp Decisions?
Job Title - Quality Control Chemist
Sharp Decisions Inc. is seeking a Quality Control Chemist for our client. This is a 100% onsite contract role with shift hours from Wednesday to Saturday, 7:00 AM – 5:30 PM. The initial contract duration is 7 months, with the possibility of extension. This position is available on a W2 basis only (no C2C candidates).
IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete
Responsibilities (include but are not limited to):
Sharp Decisions Inc. is seeking a Quality Control Chemist for our client. This is a 100% onsite contract role with shift hours from Wednesday to Saturday, 7:00 AM – 5:30 PM. The initial contract duration is 7 months, with the possibility of extension. This position is available on a W2 basis only (no C2C candidates).
IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete
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.
- 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
- 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
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