Quality Assurance Compliance Specialist IV
GENERAL SUMMARY OF POSITION:
The QA Compliance Specialist IV 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 analysisResponsibilities
- 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
- 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