Senior Quality Control Analyst

in Pharma
  • Germantown, MD View on Map
  • Salary: $78,000.00 - $100,000.00
Permanent

Job Detail

  • Experience Level Senior
  • Degree Type Bachelor of Science (BS)
  • Employment Full Time
  • Working Type On Site
  • Job Reference 0000008661
  • Salary Type Annually
  • Industry Pharmaceuticals
  • Selling Points

    Join a leading organization at the forefront of vaccine development as a Quality Control Senior Analyst. This role offers the opportunity to contribute to impactful work in a collaborative environment with strong financial backing and global reach.

Job Description

Responsibilities:

  • Performs GMP release and stability testing in Quality Control
  • Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses
  • Review of laboratory notebooks, protocols and reports
  • Perform day to day activities for cell propagation used for QC release and stability assays.
  • Participate in technology transfer, method qualification and validation
  • Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines
  • Participate in internal assessments and regulatory audits as required
  • Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
  • Leading the lab in 5S and routine housekeeping activities
  • Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
  • Other duties as assigned

Qualifications:

  • Minimum of a Bachelor's degree or equivalent in a scientific discipline  
  • Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
  • Hands on experience performing ELISA in a cGMP environment
  • Hands on experience performing SDS-PAGE in a cGMP environment
  • Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay
  • GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
  • Excellent analytical skills and knowledge
  • Strong troubleshooting skills for equipment and software
  • Solid ability to work independently (minimum supervision)
  • Ability to lead others, as needed
  • Ability to effectively collaborate with others
  • Excellent communications skills and be conversant in computer systems 
  • Excellent multi-tasking and organizational skills.
  • Excels in time management
  • Strong attention to detail
  • Have a good understanding of relevant regulatory/industry standards and requirements
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