Job Description
Job Title - Quality Control Chemist
Location - Frederick, MD Frederick, MD 21704
Duration: 12 Months
Onsite - Shift flexibility preferred
" Wed-Saturday
" Time: Day 3PM - 1:30AM EST
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):
Basic Qualifications:
Preferred Qualifications:
Location - Frederick, MD Frederick, MD 21704
Duration: 12 Months
Onsite - Shift flexibility preferred
" Wed-Saturday
" Time: Day 3PM - 1:30AM EST
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.
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.
Numbers & Facts
| Location | Frederick, MD |
| Industry | Other/Not Classified |
| Company Size | 100 to 499 employees |
| Year Founded | 1998 |
| Website | www.eteaminc.com |
About Company
Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
Skills
- Analysis Skillsunmatched
- Assaysunmatched
- Biological Assayunmatched
- Biotech and Pharmaceuticalunmatched
- Calibrationunmatched
- Case Report Form (CRF)unmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Drug Releaseunmatched
- Employee Orientationunmatched
- GMP (Good Manufacturing Practices)unmatched
- Manufacturingunmatched
- Materials Testingunmatched
- Metricsunmatched
- Microsoft Excelunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Onboardingunmatched
- Polymerase Chain Reaction (PCR)unmatched
- Presentation/Verbal Skillsunmatched
- Quality Controlunmatched
- Quality System Requirements (QSR)unmatched
- Real-time PCR (qPCR)unmatched
- Regulatory Requirementsunmatched
- Regulatory Submissionsunmatched
- Root Cause Analysisunmatched
- Secondary Schoolunmatched
- Standard Operating Procedures (SOP)unmatched
- Test Dataunmatched
- Testingunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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