Senior QC Scientist

1 month ago

Bedford, United States Anika Full time

Position Scope:


The Senior Quality Control Scientist is primarily responsible for development, validation, and transfer of methods for new raw materials, intermediates, and finished products. As assigned, perform QC activities and procedures which are required to test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions. The position follows established procedures in the execution of daily activities and completes required documentation. The position will also assist in optimization of existing analytical test methods.


Strategic Focus Areas:


  • Perform all activities within the confines of the Quality System and cGMP principles
  • Participate in projects and activities which support the growth efforts of the Company
  • Maintain cost discipline within assigned programs


Specific Tactical Responsibilities:


  • Coordinate with Tech Transfer during the scale up process to ensure test methods are transferred and implemented in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
  • Validation of all new methods and method improvements in compliance with requirements of ICH Q2B and other applicable method validation guidelines.
  • Collaborates with R&D to develop test methods for new products.
  • Performance of QC method qualification, validation and transfers through generation of protocols as applicable.
  • Writes technical reports to support method qualification, validation, transfers and regulatory submissions pertaining to method development, method validation, analytical testing results and product stability.
  • Proficiently perform QC analytical chemistry assays using HPLC, LC-MS, GC/GC-Headspace, Rheological techniques,, Karl Fisher, UV/VIS spectrophotometer, FTIR, and physical characterization by Instron equipment.
  • Test in process, stability and Engineering/R&D samples using the above listed analytical and physiochemical test methods.
  • Complete required documentation in a timely manner for all work activities according to Good Documentation Practices; reviews laboratory notebooks and verifies results of other Analysts.
  • Researches and optimizes test methods according to accepted industry best practice; performs qualification and validation of methods
  • Reports procedural deviations and nonconformances to management; performs investigations as assigned and follows through to closure of corrective action
  • Maintains current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  • Performance of QC general laboratory equipment qualification and maintenance
  • Participate in other projects as assigned


Job Complexity:


  • The position works on problems of complex scope in which analysis of situation or data requires review of variable factors.
  • The Analyst exercises judgment within defined practices and procedures to determine appropriate action.
  • The position must be able to manage multiple priorities and projects


Supervisory Responsibilities:


None


Required Qualifications:


  • BS in Chemistry or Physical Science or equivalent experience.
  • Minimum of five (5) years in a GMP laboratory developing, validating, and performing analytical methods.
  • 5+ years of method development and testing experience in FDA regulated pharmaceuticals or medical device industries
  • Highly proficient in using HPLC, GC, LC-MS analyses, Instron, Viscometer, FTIR, and UV/Vis. Demonstrated experience with complex manual and automated test methods and equipment.
  • 5+ years’ experience of technical protocols and reports write up, review and approval.
  • 5+ years’ experience with optimization of analytical test methods
  • Skilled in various wet chemistry techniques such as titrations and ID testing using the USP, EP and FCC compendia
  • Self-motivated with good time management and organizational skills
  • Good communication and writing skills
  • Demonstrated experience with GMP/ ISO regulations
  • Constantly strives to exceed goals, requirements, accomplishments and expectations
  • Ability to work flexible hours to complete work activities


Desired Experience, Knowledge, and Skills:


  • Experience with testing textiles, gels, solids, and liquid suspensions
  • Experience working in fast and high-volume commercial plant
  • Ability to handle multiple priorities and meet established deadlines
  • Experience maintaining working with Excel performing calculations and graphing operations

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