Senior Quality Engineer

Role Summary

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant, including deviation resolution, product impact analysis, corrective and preventive action, investigations, approval of standard operating procedures, calibration program oversight, quality improvement programs, and ensuring cGMP and policy compliance for the manufacturing site.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that all quality goals are met and that practices and procedures comply with company policies and applicable regulations for the Quality areas under their responsibility.
• Investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and place product on QA hold where appropriate.
• Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures; ensure procedures comply with policy and are sensible.
• Approve calibration requests and ensure that these requests have appropriate product/process limits assigned.
• Audit commissioning and validation documentation.
• Develop product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA‚Äôs. Develop and implement statistical quality programs and process monitoring systems.
• For specific U.S. manufacturing sites, perform batch release.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing

Skills

• Quality systems and regulatory compliance
• Investigation and CAPA processes
• Validation and commissioning documentation auditing
• Statistical quality programs and process monitoring
• Effective communication and cross-functional collaboration

Education

• High-value degree in Biology, Chemistry, or Engineering preferred

Additional Requirements

• Roles located in locations with pay disclosure requirements may include compensation disclosures as applicable by law.