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Scientist, Quality Associate, Sr.

Your Role:

 

The Scientist, Quality Associate, Sr position is responsible for the routine analysis of samples in the Quality Control department and all related cGMP paperwork.  Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.  The position is responsible for organizing and performing analytical equipment calibration/verification and maintenance.  This position is also responsible for assisting with method qualification, writing protocols and standard operating procedures.  Other responsibilities include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit ready state. The Scientist, Quality Associate, Sr position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. 

 

ESSENTIAL JOB FUNCTIONS

 

  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.  
  • Exercise judgment within generally defined procedures and practices to select technique for obtaining solutions.
  • Able to solve problems and make decisions with assistance.
  • Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program.
  • Develop testing methods to support cleaning verification program; validate or verify methods as necessary.
  • Perform cleaning verification by executing existing methods.
  • Perform preliminary review of analytical data for accuracy and quality.
  • Help train new or less experienced personnel in SOP content and analytical techniques and methodologies.
  • Meet with internal project groups to keep projects on track.
  • Maintain projects and timelines with minimal oversight.
  • Execute method transfers into QC and write summary reports.
  • Perform method validations and write technical reports.
  • Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair.
  • Analytically test in-process, final products, intermediates and raw materials.  Recognize problems with analytical test results or method performance and take appropriate steps to address them. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
  • Participate in OOS investigations via testing and good documentation. 
  • Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor
  • Perform requalification of reference standards, and maintain reference standard inventory/documentation.
  • Write and revise SOPs including raw material, intermediate, and final product specifications.
  • Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
  • Demonstrate proper laboratory techniques.
  • Work cooperatively within the QC department and with other departments to achieve project goals.
  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
  • Work in a safe manner and maintain the cleanliness of the work environment.
  • Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.

     

Who You Are:

 

Basic Qualifications:

B.S. in Chemistry or related biological sciences.

 

Experience:

2+ years in a GLP or cGMP analytical laboratory environment, or equivalent industry experience.

 

Knowledge and Skills:

Excellent written and verbal communication skills, as well as excellent documentation practices.  Ability to work in a team environment.  Ability to work in analytical testing labs with hazardous and toxic chemicals.  Knowledge and understanding of organic analytical chemistry.

 

ADDITIONAL LOCAL NEEDS

 

Environmental conditions:  Work near moving mechanical parts.  Frequently required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.  Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators, Saranex and/or Tyvek suits with powered respiration.

 

Physical requirements:  Regularly required to sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.  Must occasionally lift and/or move up to 50 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments.  May be required to lift more poundage with assistance.  Must be able to speak, hear, taste, and smell.  Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.  Regularly use phones, computers, computer monitors, and all office/laboratory equipment.  Required to type at a computer keyboard and have the ability to read CRTs/computer monitors.

Job Requisition ID:  187592
Location:  Verona
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


Job Segment: Chemistry, Scientist, Laboratory, Senior Scientist, Science, Quality

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