The Quality Control Analyst is responsible for performing analytical testing and data review activities on inactive and active ingredients, packaging components, and in-process products, finished products, and stability samples. These activities are designed to ensure that products manufactured, packaged, or marketed are safe and meet established quality standards. All activities are performed with a dedicated focus on current good manufacturing practices (cGMP), safety, and regulatory compliance.
Foster positive and productive work environment to meet testing and business needs of
Production Operations for commercial and/or new products.
Organize and manage information required to meet FDA regulatory and cGMP
Provide sound scientific process to problem analysis and decision-making in accordance
with cGMP compliance standards.
They may also provide an independent technical and compliance review of their peer’s work prior to final management approval.
With general guidance from a Team Leader or Manager, the Analyst is permitted to determine the order of experiment execution and how best to manage multiple tasks during the course of the day in order to meet defined timelines.
They may work on problems and investigations of moderate scope where previous investigative experiences and past practices can be used to select methods and techniques for obtaining solutions.
1. Perform analytical testing on inactive and active ingredients, packaging components, and in-process products, finished products, and stability samples to ensure product is safe, effective, and meets established quality standards. Train/mentor additional QC staff on analytical testing as needed.
2. Review or prepare documentation of all laboratory work (e.g., test results, investigations, instrumentation/equipment preventative maintenance and calibration) in accordance with cGMP, cGLP, or SOPs, as appropriate. Ensure all laboratory work is conducted in compliance with applicable safety and environmental regulations.
3. Use a wide variety of sophisticated equipment with responsibility for operation, maintenance, and daily calibration check (if appropriate).
4. Assist with drafting and/or revising formal documents (i.e., test protocols, summary reports), SOPs, and procedural guidelines when provided with the appropriate format.
5. Provide support for method validation, technology transfer activities, and formulation development. Assist with preparing formal reports by organizing results in a comprehensive tabular form. Draft test methods, standard operating procedures (SOPs), procedural guidelines, validation and stability protocols when provided with the appropriate format. Possess theoretical knowledge of the scientific methodologies and assume expert role of proficiency in at least 1 microbiology process or technology. Demonstrate proficiency on variety of (manual and automated) microbial identification techniques. Use a wide variety of sophisticated equipment with responsibility for operation, maintenance, and daily calibration check (if appropriate) of one instrument/equipment/system. Train analysts to use equipment when requested by supervisor.
• M. S. or Bachelors in Chemistry/Biology or equivalent discipline, with appropriate experience (Typically 3+ years), OR Associate degree or High School Diploma with appropriate equivalent experience (Typically 18 + years)
• Knowledge and demonstrated proficiency in pharmaceutical analysis and analytical and microbiological techniques. Experience with variety of instrumental and wet chemical methods, including trouble-shooting laboratory instrumentation
• Knowledge of stability requirements for commercial products
• Experience with problem-solving, especially for handling out of specification data.
• Proven ability to manage changing priorities
• Knowledge of cGMPs and laboratory safety.
• Strong interpersonal communication skills
• Critical thinking with ability to identify issues requiring further attention and ability to initiate and facilitate resolution of those issues.
Desirable but Not Essential
• Experience with method validation and technical transfer activities. Experience in methods development and validation desirable and knowledge of USP Drug Release testing desirable
• Experience with commercial/start-up operations
• First line experience interacting with Regulatory Inspectors/Internal Auditors
• Demonstrated ability to work independently with minimal supervision.
• Knowledge of root cause analysis and conducting sound, scientific investigations