Key Duties will include:
- Supervision of a staff of 6 to 8 individuals who work across multiple shifts.
- Demonstrate strong leadership skills.
- Develop and coach direct reports to achieve goals based on corporate and site objectives by optimizing resources and building team effectiveness.
- Quality at the source utilizing on the floor real time batch record review, disposition and in process auditing.
- Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.
- QA oversight of manufacturing processes. Provides quality guidance to manufacturing personnel to manage resolution of in-process deviations.
- Write and revise Standard Operating Procedures (SOPs).
- Review and approval of GMP documents such as batch records, logbooks, and reports to ensure compliance with specifications, regulations and procedures.
- Actively involved in daily operations to meet schedules and to resolve problems.
- Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.
- Train and mentor personnel on processes to resolve open issues resulting from record reviews, on the floor walk through activities, and deviation issues.
- Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans.
- Implementation of solutions for identified issues affecting daily manufacturing operations.
- Represents Quality Assurance to guide various project and technical meetings, as needed.
- Support and manage existing and/or develop and implement new programs, processes designed to drive continuous improvement.
- Review and approval of Standard Operating Procedures (SOPs), and Master Batch Records (MBRs).
- Supports and Assists Quality Systems on timely closure of CAPA’s, Gap Analysis and Product Complaints.
- Track and trend metrics for QA on the Floor audits, Logbook audits and In-Process Audits metrics monthly for Senior Management.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
BS or BA degree in Science or Engineering with 6-12 years of QA experience with at least 3 years in a GMP environment or FDA regulated industry. Minimum of 2-3 years of Supervisor/Manager experiencerequired.
- Must have strong attention to detail.
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Excellent written and verbal skills.
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to use computer programs such as an electronic Document Management System and SAP.
- Ability to work in a team environment.
- Proficient knowledge of cGMP.
- Coordinate multiple tasks simultaneously.
- Understand and respond to a diverse population.
- Gowning certification required.
- Ability to make sound decisions regarding compliance-related issues.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.