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GENERAL SUMMARY OF POSITION:

The QA Compliance Specialist IV, Senior level position is responsible for ensuring that quality standards are met in a cGMP Biologics Manufacturing facility by performing a wide variety of activities to assure compliance with applicable regulatory requirements. These activities include, but are not limited to: conducting audits, designing and executing programs, data and documentation reviews and analysis

MAJOR RESPONSIBILITIES:

• Facilitate the review and approval of deviation reports; ensures appropriate corrective actions are assigned.
• May be responsible for managing the development, implementation and maintenance of Quality Assurance Training systems and activities. Assures training is conducted and documented per GMP requirements. 
• Develops and manages GMP orientation program and ongoing GMP training for all GMP related departments.
• Processes change controls for closure; ensures required tasks are completed.
• Plans and conducts audits of co-manufacturers and vendors
• Plans and conducts periodic internal audits of production and laboratory areas.  Writes audit reports.
• Reviews completed batch records, related records, and validation packages for compliance to cGMPs and internal requirements.   Reviews and approves SOPs, in-process forms, and validation protocols.
• Reviews audit findings and completion of corrective actions.  Provides periodic reports to management regarding status of audits and corrective actions.
• Prepares annual product reports.
• Applies knowledge and understanding of current regulations to make recommendations to senior staff.
• Performs additional job related duties as required

REQUIRED QUALIFICATIONS:

• Requires BS degree in a scientific discipline or equivalent and a minimum of 8 years relevant experience or equivalent
• Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems, and thorough understanding of how cGMP regulations and guidances apply to investigational and market licensed biologics
• Demonstrated ability to train and supervise others
• Ability to conduct complex troubleshooting
• Ability to assess issues and make Quality decisions of a moderate scope within established procedures and policies.
• Working knowledge of current Good Manufacturing Practices and Quality Assurance systems
• Must possess the ability to interpret and apply current GMP regulations and internal Quality policies consistently.
• Computer literate and knowledge of WordPerfect or MS Word, and Lotus or Excel.  Demonstrated skills in developing and organizing systems for management of information. 
• Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity.
• Ability to work well independently and in a team environment
• Demonstrated excellent verbal and written communication skills