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Smith & Nephew

St. Petersburg, FL, 33713, USA

Tracking Code 2009680 Job Description GENERAL SUMMARY:
  The Product Control Specialist is primarily responsible for ownership and maintenance of the stability program which is described in established quality procedures/polices, such that the program complies with all domestic and international regulatory, industry and internal standards, as applicable.  In addition, this position has the responsibility for OTC annual drug reviews for the US, Canadian product release and Canadian annual confirmatory testing/reporting.  This position may also provide support for applicable quality system areas as needed. Essential Job functions:
   * Responsible for the establishment of the stability program for existing and outsourced studies. * Writes and/or reviews  needs assessments, stability study protocols, stability reports, etc for existing and outsourced manufactured products. * Completes necessary reporting at defined intervals. * Performs statistical analysis of stability data in order to detect stability indicating trends. * Responsible for supporting outsourced stability products as required. * Performs and coordinates OTC annual drug review program which includes coordinating data collection, testing and report writing as described within procedures. * This position is responsible for Canadian release requirements for natural health products, drugs or others as needed. * Coordinates and submits the annual confirmatory testing/report requirements for Canada. * Provides guidance and training to internal and external customers on stability requirements, project support and other quality system activities as needed.   Required Skills - Knowledge of Sterilization methods with a Background in Chemistry and Microbiology is required. - Requires operation of scientific calculator, laboratory instruments and Microsoft applications (i.e. Access, Excel, Power Point, Minitab, Word and Microsoft Office). - Statistical analysis (Excel, Minitab) is preferred.  Audible/Visual Demands:
This job requires the candidate to be able to effectively communicate (to include speaking, reading and writing) in the English language.  This job requires the ability to visually evaluate data, reports, SOPs and regulations (all written in English) to ensure compliance and continuous improvement.  Job can demand up to 100% of working day spent in front of a computer screen. Risks/Hazards– The risks / hazards associated with this position may include working around live cultures (e.g. bacteria, yeasts and molds), acids, bases, inorganic and organic solvents.  The appropriate PPE is provided to minimize risk.  Physical:
It may require standing and walking 50% on any given working day.  It may require lifting up to 20 lbs. Required Experience Education:
As a minimum, Bachelor's Degree in Chemistry or related a field. Experience:
At a minimum, three years experience as a chemist or Microbiologist in any position related to a stability program in a FDA regulated quality control/assurance department in a pharmaceutical or related industry.  Must have a complete understanding of the compendial requirements, ICH guidelines and FDA regulations as they relate to the stability program.  Experience with statistical analysis (Excel, Minitab) is preferred.    Familiarity with validation activities, CAPA and change control a plus.    Job Location St. Petersburg, FL, US. Position Type Full-Time/Regular GBU Wound

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