QC Specialist- Method Development & Validation Team - copy

Croda Int-posted 7 months ago
Senior
Alabaster, AL
1,001-5,000 employees
Chemical Manufacturing
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The QC Specialist is responsible for biological and chemical evaluation of raw materials, in process, final release and stability samples ensuring compliance and timely completion of assigned task as well as other auxiliary laboratory support functions. This includes developing QC assays, collaborating on specifications, performing validation of QC assays, and writing Standard Operating Procedures. The QC Specialist may also be cross trained on multiple instruments and methodologies or be specialized in one analytical technique. They will serve as a subject matter expert in defined areas and provide training and guidance to other analysts where needed.

  • Perform laboratory testing using standard laboratory procedures, principles, practices, concepts, and theories
  • Develop new analytical methods for the release of products, raw materials, or intermediate compounds
  • Working knowledge of FDA regulations and ICH guidance for analytical method validation
  • Have a complete mastery of assigned SOPs and can train others in their execution
  • Develop and write SOPs as needed following GMP guidelines
  • Perform daily operation and routine maintenance, calibration, and assist in troubleshooting of laboratory instruments and equipment
  • Prepare and maintain standard operating procedures and prepare documentation for test verification or validation studies
  • Transfer strong knowledge of GMP guidelines/practices to new laboratory protocols and situations
  • Serve as a Subject Matter Expert (SME) and trainer on various analytical techniques and equipment
  • Collaborates with management to identify and promote method improvement and equipment needs of the department ensuring continuity and sound scientific principle
  • Promotes overall cleanliness/neatness of lab and storage areas
  • Communicates problems or potential issues in a timely manner
  • Review of testing/documentation to ensure accuracy, and compliance
  • Maintain an understanding of cGMP and compliance in an analytical setting
  • Monitor and complete all business tasks within timeframe to ensure optimal quality and efficiency
  • Perform upkeep of employee training records
  • Prepare and align individual performance goals with department goals
  • Complete company-required training programs
  • Adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance as outlined in the company's Standard Operating Procedures, Chemical Hygiene Plan, Emergency Contingency Plan, training memoranda, policy memoranda, Safety Data Sheets, Specification Records, etc.
  • Bachelor's degree required, Master's degree or PhD preferred, in a natural science such as Biology, Chemistry, Clinical Sciences or Pharmacology
  • A minimum of 10 years of relevant experience is required
  • Strong attention to detail
  • High level of integrity and reliability
  • Ability to manage multiple projects simultaneously
  • Strong organizational skills
  • Excellent written and verbal communication skills
  • Self-motivated
  • Ability to work both in a team environment and work independently
  • Ability to communicate effectively with fellow employees
  • Advanced math skills required
  • Exceptional presentation and facilitation skills
  • Ability to write reports, business correspondence, and procedure manuals
  • Ability to effectively present information and respond to questions
  • Ability to define and communicate problems, collect data, establish facts, and draw valid conclusions
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