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"Are you a good fit for this job? Work Plan Step Project Lead-Manufacturing- in Lancaster, PA Work Plan Step Project Lead-Manufacturing-Lancaster,PA Contract position 12-24 months send resumes to: bciociola@covexllc.com Education: University/Bachelors Degree or Equivalent Experience/Technical Competencies: • 10+ years within an operations or manufacturing environment either within a Pharmaceutical / Medical Device or Consumer Industry. • Experience within a third party or consent decree environment Experience with Quality Systems, Quality Standards and Regulatory Documents • Bi-lingual preferred (Spanish & English) Job Knowledge/Skillsets: • MS Office Skills: Word, Excel and Visio • Ability to drive action • Technical knowledge of supply chain procedures and documentation • Technical writing ability • Ability to gather information, analyze and develop tactical plan • Acts decisively, setting clear goals and objectives • Demonstrated collaboration skills • Must have ability to comprehend manufacturing processes and equipment • Must have good verbal and written skills, and proven analytical ability Travel: <10% Contract Length: 12-24 months This position is responsible for improving and implementing key quality systems elements to address consent decree work plan commitments for manufacturing operations sites within comapny PPC. This lead position will ensure and assist work teams in creating and delivering new manufacturing solutions and quality systems within a cGMP environment. This candidate will also be responsible for prioritizing consent decree work plan step activities and meet detailed project plan requirements. • Enable and empower work teams with suggestions, solutions and a sustainable process for the manufacturing operations teams. • Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA. • Support the ongoing consent decree work plan by: o Attending and participating in meetings related to work team activities. o Lead and provide guidance to work teams to ensure proper solutions and gaps are addressed in conjunction with consent decree work plan due dates. o Update QSE Core Team with project updates and timelines on a periodic basis. o Mitigate and remove roadblocks for Subteams. o Escalate challenges and successes to QSE Core Team. o Demonstrate positive team-oriented approach in the daily execution of activities. o Promote and work within a team environment o Coordinate training activities and develop training curricula’s o Coordinate and ensure third party confirmation and verification of all consent decree work plan steps within QSE. o Maintain a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations. • This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned. http://bull.hn/l/OIXL/6" |
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Wednesday, July 18, 2012
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