Assistant Manager, Raw Materials
FPCNational - Wisconsin

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Detroit, MI
Relocation available for qualified candidates

My client markets and distributes generic pharmaceuticals to the nation's largest wholesalers, distributors, warehousing and non-warehousing chain drugstores, and managed care providers and through its parent company, is a vertically integrated manufacturer with the flexibility to develop and manufacture on or off shore .
The ideal candidate will have a minimum of eight years combined experience in various aspects of quality assurance/quality control in pharmaceutical manufacturing. A minimum Bachelors Degree in Chemistry or other related biotechnology field.

The Assistant Manager of Raw Materials will be responsible for the direction and coordination of quality operations in support of meeting
or exceeding cGMP and FDA requirements.
Insures accordance with quality, safety standards and all regulatory requirements.
Insures timely implementation of testing and in-process monitoring systems to ensure process control and product quality. Essential dutires include being

responsible for timely sampling of raw material, receiving raw material into the QC laboratory, all QC/AD/RD outside testing coordination, Mfg COA review,
the release of raw materials, addressing raw material FDA deficiencies, and retrieval and distribution of all raw material retain samples.

Requirements:
Ability to motivate others through forward looking practices in the quality field. Knowledge of employee practices and principles, knowledge of state and
federal employment laws relating to key areas of responsibility.
Responsibly for analysis reporting, communication and presentation. Information and technology proficiency, problem solving and decision making.
  • Requires knowledge in Chromatography, Dissolution Testing, Spectroscopy, FTIR, and Wet Chemistry
  • Ability to plan and manage large amounts of testing with high level of quality
  • Requires advanced knowledge of computer and lab equipment
  • Must have ability to interpret analytical data and document analytical details appropriately
  • Hands on experience in HPLC, GC, and UV analysis
  • Requires knowledge of analytical method development and validation
  • Requires knowledge of ICH, FDA and Regulatory guidelines
  • Requires knowledge of compendia requirements
  • Good written and oral communication including strong technical writing skills.
  • Above average project management skill Must be detail oriented and organized
  • Above average record keeping skills and documentation of laboratories testing
  • Interpretation and troubleshooting of chromatography
  • Advanced level laboratory leadership and operations experience
  • Ability to initiate, perform and oversee OOT/OOS investigations
  • Must have ability to interpret analytical data and document analytical details appropriately
  • Intermediate in MS Office

FPCNational - 16 months ago - save job - block