Job Title: Quality Control Chemist
Duration: 6 Months
Location: Frederick, MD
Onsite - Shift flexibility preferred (First 7 weeks of training M-F)
* Wednesday to Saturday
* Time: 7am-530pm
IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri ) 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.
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
Duration: 6 Months
Location: Frederick, MD
Onsite - Shift flexibility preferred (First 7 weeks of training M-F)
* Wednesday to Saturday
* Time: 7am-530pm
IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri ) 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.
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
Quality Control Chemist - I in waldorf at Unknown Company
This position is listed as contract and onsite.