Compliance Associate IV

Manufacturing site for Solid Dose Generics seeks a qualified candidate for the position of COMPLIANCE ASSOCIATE IV that " CAN MAKE A DIFFERENCE."

JOB RESPONSIBLITIES: Lead/manage remediation activities and projects conducted by cross-functional matrix teams. Responsibilities: Seek stakeholder input and win their support. Lead/manage multiple project teams and activities in parallel work streams. Provide oversight and direction of compliance initiatives by keeping teams focused, with adherence to project timelines. Ensure compliance with project plans regarding cost, quality, resources and scope. Develops FDA communications, including written responses. Develop compliance policies. May participate in developing audit plans, executing internal audits, writing reports, and communicating the results of compliance audits and forming responses. Develop/assist with internal/external inspection readiness planning and execution. Supports and meets Departmental, Plant and Corporate HS&E goals. Works in a safe and efficient manner.

EDUCATION:

Required B.S. in Science/Pharmacy or related field

EXPERIENCE:

Required minimum 5 years of Pharmaceutical experience (must include some Quality/Compliance/Regulatory experience).

Preferred experience in both sterile and non-sterile products.

Capable of limited travel (1-4 times/year).

SKILLS / KNOWLEDGE:

 Required knowledge of GxP regulations and ability to implement solutions based on knowledge. 

Excellent verbal/written communication, strong detail orientation, negotiation/influencing, leadership, capability to perform risk assessment, rapid comprehension of complex situations.

Basic Computer Skills: MS Word, MS Excel, MS PowerPoint, Adobe Acrobat, ability to learn execute data entry into various databases.

This positions offers an excellent package of salary, bonus, 401 K, and relocation. Please respond with a Word Attachment Document.