QA Supervisor / Manager
Phoenix, AZ 85001
The QA Supervisor/ Manager is responsible for the development, implementation and on-going continuous improvement of the site’s Pharmaceutical Quality System. The QA Supervisor/Manager effectively conducts and supports problem investigations and disposition of material and finished goods. The QA Supervisor/Manager serves as a frequent inter-organizational contact and represents the department on project teams. Will review and approve a wide variety of GMP related documents. This position will also provide leadership during regulatory agency and customer inspections, cGMP training as required, and validation review. The position is responsible for the management and oversight of other QA professionals. The QA Supervisor/Manager interacts with manager and director levels of management in all departments in developing solutions and conveying information and can at times serve as the delegate for the Director, QA Operations.
Job Specific Responsibilities:
- Ensures the Pharmaceutical Quality System is efficient for the business while maintaining compliance (deviations, change controls, CAPAs, etc.).
- Ensures Quality Metrics are delivered.
- Provides leadership and support of all external audits, including organization of departments to ensure a smooth audit process.
- Reviews and approves documentation such as procedures, protocols, reports as required by US and European regulations.
- Provides Quality Assurance review and approval of deviations. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective.
- Ensures management is notified of product and process risks.
- Provides Quality Assurance review and approval of product and process related documentation including risk assessments.
- Create new batch records
- Review & approve batch record
- Process validation documents for new products
- Understands the importance of working in a start-up environment and must have the ability to be hands on (tactical) and strategic.
- 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.
- Monitors subordinates’ attendance. Reviews and approves vacation and leave requests. Authorizes all overtime. Verifies and approves time cards.
- Manages employee performance by clearly defining job responsibilities and standards of performance; providing clear, thorough, timely feedback. Promptly addresses performance problems through corrective action.
- Evaluates and appraises employee’s performance and follows-up with proper documentation.
- Investigates and addresses employee complaints and follows up with Manager and HR as required.
- Ensures self and staff keep up-to-date on technical knowledge and developments that impact roles.
- Ensures an effective learning environment by coaching employees, orchestrating learning opportunities, and providing relevant, high-impact feedback.
- Assists in interviewing and hiring for subordinate staff.
- Understands HR policies and practices and uses them to manage employees.
- Conducts ongoing assessment and training needs identification including maintaining the training / skill matrix for assigned shift. Creates learning opportunities for all staff as part of daily operations.
- Responsible for performance of direct reports
- A./B.S. Chemistry, Biology, Pharmacy, Health Science or closely-related field.
- Minimum 5 to 10 years Quality Assurance experience in FDA regulated environment.
- Prior experience related to computerized systems compliance required or a plus.
- Sterile and/or aseptic manufacturing experience in a pharmaceutical setting strongly preferred.
- Minimum 2 years of supervisory experience required.
- A comprehensive understanding of current regulatory requirements and ability to interpret them. QA/compliance experience in manufacturing, facility operation, laboratory compliance and quality systems. Experience in leading audits and supporting regulatory inspections. Good teamwork and project management skills (including the ability to lead teams). Requires excellent communication, interpersonal and organization skills.
- Must be able to recognize situations where there is a potential impact on product quality, safety, identity and purity. Encourages self and others to consider innovative approaches to addressing problems and developing solutions that are effective and compliant. Responsible for developing and ensuring full implementation of an appropriate solution.