Title: Quality Assurance Manager-Microbiology
Reports to: Quality Control Manager
Purpose: The Quality Assurance Manager-Microbiology will ensure that products developed are of high quality and all related materials, processes and personnel comply with the requirements of relevant regulatory authorities. The QA Manager will collaborate closely with all functional units in the organization. He/she will coordinate and implement the oversight and improvement of new and existing quality systems. The QA Manager will implement and oversee the site sterility assurance programs and microbiological testing.
Duties and Responsibilities:
- Establish and ensure appropriate quality systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality improvement opportunities and prevention of quality issues*
- Provide coaching and mentorship to the quality team, ensuring appropriate levels of accountability for quality decisions and clearly communicates cross-functionally within the organization*
- Manage all aspects of plant quality systems, including document control, deviations, CAPA, supplier quality, change control, quality assurance, finished product review and release*
- Work with other quality/compliance, manufacturing, warehouse, purchasing and finance managers and personnel to effectively create and support process and quality enhancement initiatives*
- Support an aggressive quality program, which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies*
- Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant
- Author, approve and/review area quality deviations and investigation reports as appropriate*
- Ensure on-time completion of all corrective action items*
- Prepare annual reports and conduct internal/external audits to assure cGMP compliance.*
- Identifies and defines acceptable aseptic manipulations, and interventions and the associated controls, to be used in manufacturing processes based on risk analysis*
- Provides oversight of the site integrated sterility assurance programs including: aseptic process simulations, cleaning / sanitization programs, sterility assurance risk assessment strategies and development of sterile projects*
- Serves as a sterility assurance subject matter expert*
- Oversee and monitor facility-wide training including awareness of company quality policies and cGMP training as well as maintain training curriculum and documentation for staff.
- Supervise, coach and develop staff. Complete regular performance evaluation of staff including the identification of development needs.*
- Extensively interact with all levels of personnel to resolve quality issues.*
- Collaborates in cross-functional teams*
- Follows all Aurora Pharmaceutical policies, procedures, regulations and the employee handbook.*
- Assumes additional responsibilities as requested.
- Demonstrates flexibility, i.e. willingly takes on new tasks.*
- Prioritizes projects and meets deadlines *
- Clearly and accurately communicates with all levels of employees*
(*denotes essential job function)
Knowledge, Skills and Abilities:
- Strong working knowledge of FDA requirements and guidance documents
- Excellent written, verbal and presentation skills
- Highly organized, approachable, flexible and able to respond to changes in a dynamic environment
- Extremely detail oriented
- Expert knowledge of cGMP requirements
- Strong knowledge of process and computer validation requirements
Education and Experience:
· Bachelor of Science in Chemistry or Microbiology. Master’s degree preferred.
· 4 years of experience within the pharmaceutical or biotechnology industry preferred
· Prior experience in managing inspections performed by FDA and other regulatory authorities.
· Previous supervisory experience required
· Lean/Kaizen/Six Sigma working knowledge preferred
· Microbiological/environmental monitoring and trending experience in a highly controlled drug manufacturing environment, including sterile fill is desirable
This job description is subject to change at the sole discretion of Aurora Pharmaceutical.