ATR ID:

ATR225684

Job Title:

Quality Control Chemist - I

Job Level:

Scientific/Biotech

Duration:

12 Months

Location:

Frederick

MD 94404

Education:

• 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
  

Email:

Kelly, Edward

Phone:

408-328-8095

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.

Requirement:

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. How to

Apply:

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