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QC Biochemist

The Fountain Group LLC
  • Frederick, MD
  • $20–$30 Per Hour
  • Instant Apply
5 days ago

Job Description

Currently we have an opening for a QC Biochemist located in Frederick, MD. Details for the position are as follows:
 
Pay Range: $20-$30/hour

Job Description:
  • 6-month contract with the possibility of extending or converting to permanent based on performance and budget.
  • For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri 7:30am-4pm to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift.
  • Shift: Wed-Saturday - 3PM - 1:30AM EST
  • 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

LocationFrederick, MD
IndustryStaffing/Employment Agencies
Salary$20–$30 Per Hour
Company Size500 to 999 employees
Websitehttps://www.thefountaingroup.com/

About Company

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

Skills

  • Analysis Skillsunmatched
  • Assaysunmatched
  • Biochemistryunmatched
  • Biological Assayunmatched
  • Biotech and Pharmaceuticalunmatched
  • Budgetingunmatched
  • Calibrationunmatched
  • Case Report Form (CRF)unmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Drug Releaseunmatched
  • Employee Orientationunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Maintain Complianceunmatched
  • 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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