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In this critical and visible role, you will lead a group in ensuring that current Good Manufacturing Practices (cGMP) are followed during the receipt, sampling, storage, testing, manufacturing, packaging and distribution of components, intermediates and finished goods. Reporting to the Executive Director, Quality Systems and Regulatory Affairs, the successful candidate will be responsible for the management and oversight of the product release group, documentation control and include the review, release and sign off of all raw materials, packaging components, intermediates, and finished products.
• Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance.
• Evaluates effectiveness of Standard Operating Procedures (SOP), identifies changes that would enhance the process, and ensures that all change control documentation is implemented.
• Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done.
• Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance.
• Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
• Reviews and approves assigned GMP documentation, and site process change controls.
• Represents QA on cross-functional teams (i.e. product development/product transfer projects) for the purpose of ensuring the right GMP documents and processes are in place to support operations.
• Ensures stakeholders are appropriately trained on the process and any process changes. Creates learning opportunities for all staff as part of daily operations.
• Responds to customer questions regarding the release process and/or documentation.
• Provides supervision and direction to staff and coordinates work flow within the work unit, including distributing work, disseminating information, assigning staff to cover for absences, providing technical assistance, answering questions, and resolving problems. Ensures work is scheduled effectively; and checkpoints and controls are set for monitoring progress.
• Evaluates and appraises employee’s performance and follows-up with proper documentation.
• Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
• Reviews and approves investigation reports to ensure it contains the appropriate level of detail; and appropriate CAPA’s are identified.
• Supports and/or performs internal/external auditing or agency inspections.
• A Bachelor’s Degree in Chemistry, Biology, Pharmacy, Health Science or related field and 5 years of QA experience in an FDA regulated environment is required.
• Minimum 1 year of supervisory experience highly preferred.
• Comprehensive understanding of current regulatory requirements, ability to interpret them as well as a background in manufacturing, facility operation, laboratory compliance and quality systems are a strong plus.
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