The GMP Auditor will work closely with QA, QC, Materials Management and External Manufacturing to assist in identifying strategies, tactics and objectives for product quality and GMP compliance:
Perform external audits of vendors and suppliers and generate reports providing recommendations on results of audit
Perform internal audits of GMP and other departments as needed to assess compliance with approved operating procedures and GMP regulations
Review/Approve/Write/Revise Standard Operating Procedures, Work Instructions, Policies, Protocols and Reports related to departmental activities
Generate trending reports to update management of various departments on GMP Compliance status
Manage the receipt and processing of Supplier Change Notifications
Monitor the performance of Suppliers, Contract Testing Laboratories and Contract Manufacturing Organizations to determine appropriate oversight and GMP compliance.
Participate in inspection preparedness to maintain inspection readiness.
- Conducts internal and external audits and works with vendors / internal departments to ensure appropriate responses are submitted in timely fashion
- Manages and tracks corrective actions (CAPA’s) and works with external suppliers / departments on completing them on time
- Works with functional departments in collecting data trends of critical operations within these departments and generated trending reports for cross functional review
- Helps maintain the internal and external auditing schedules and vendor status reports
- Conduct Supplier Performance Monitoring documenting compliance status
- Support receipt and tracking of supplier change notifications
- Assist in inspection preparation activities
- Other assigned responsibilities as established by QA Supplier Qualification & Auditing Lead
Education and Experience Requirements
- BA/BS in scientific discipline or equivalent work experience
- A minimum of 5-7 years in a global pharmaceutical / biotech manufacturing environment with exposure to Quality and Manufacturing fields
- Experience participating / leading internal and external audits
- Working knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations
Key Skills, Abilities, and Competencies
- Knowledge of domestic and international CGMP Regulations
- Quality Management Systems such as Supplier Qualification Change Control and CAPA management
- Ability to communicate effectively with wide range of personnel
- Solid technical writing skills related to audit reports
- Ability to organize cGMP system procedures based on regulatory / compliance regulations
- Must have strong attention to detail
- Strong analysis and problem-solving skills
- Participate on cross-functional teams in supplier identification and qualification
- Proficiency with computer programs
Complexity and Problem Solving
- Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive working relationships internally and externally.
- Works under minimal supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals.
- Ability to establish facts, define problems, collect data and draw valid conclusions
Ability to work collaboratively in the process of problem solving of any issues related to the quality systems processes
- Ability to be assertive to ensure conformance to cGMPs while maintaining a collaborative environment
Internal and External Contacts
- Frequent internal company and external contacts. Represents organization on specific projects
Other Job Requirements
- Travel up to 30% may be required
- The position may require occasional shift work, including weekends, off hours and holidays as needed.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.