Under moderate supervision of the Sr. Operations Manager, this role is responsible for meeting Quality and Operational goals and directing, leading and mentoring QA associates. The incumbent will be the most senior member of management after hours and will have responsibility for operations, safety and security of the facility. This is a 3rd shift position - 11:00 PM - 7:30 AM Sunday - Thursday nights.
This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate's responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately. PRIMARY DUTIES AND RESPONSIBILITIES:
- Responsible for Quality activities in each packaging room, coordinating with QA Packaging technicians to direct activities in the packaging rooms, and maintain a regular visible presence on the floor. Has the overall responsibility for the performance of the QA technicians, including quality, safety and customer service on a given shift.
- Works closely with Operations Manager to ensure product produced meets all applicable standards.
- Maintains Good Manufacturing Practices (GMPs) and follows Standard Operating Procedures (SOPs) related to the quality of our packaging lines.
- Demonstrates First Time Right for batch record review.
- Demonstrates an understanding and articulates to the team quality concepts such as: cost of quality, analytical metrics and /or statistics, trending, quality planning, validation, CAPA, problem solving, and critical thinking to determine root cause of problems that arise.
- Support production to meet customer delivery requirements on time, first time, every time. Responsible for ensuring that daily quality and manufacturing targets are met.
- Participant and leader of project teams. Responsible for overseeing activities on assigned shift to promote improved efficiency and effectiveness of quality process, including completion of gap assessments and action plans. Also includes oversight of 5S and other lean activities.
- Responsible for various record keeping activities including but not limited to batch records and shift reports. Competent in editing batch records and compiling constructive narrative information pertaining to batch production. Reviews batch record for completion and proper documentation.
- Excellent management skills to supervise personnel and interact with other departments at all organizational levels. Facilitates team meeting and reviews.
- Demonstrates ability to perform investigation/root cause analysis and develop corrective actions.
- Creates an environment of inclusion and engagement.
- Inspects and releases quarantined packaging material or rejects. Inspects finished drug product and verifies reconciliation of labels and inserts.
- Oversees and performs on -the -job training.
- Assists in performance management review programs.
- Responsible for hiring, training, development, and mentoring of QA Technicians. Coordinates shift staffing with Sr. QA Manager and other leadership personnel.
- Completes accident/incident reports and conducts investigations. Participates in follow-up meeting and CAPA.
- Assists in writing/revising and maintaining task, department, general SOPs, Work Instructions and forms.
- Required to work various shifts, hours and weekends.
- Reviews and approves associates time and attendance for payroll. Approves/Denies time off request, ensuring that staffing is maintained appropriately to allow for Safe and Quality focused production to meet business demands.
- May provide backup coverage for QA Manager when needed.
- Performs related duties as assigned.
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
Requires a bachelor's degree with at least five (5) years of experience in the Pharmaceutical and/or Quality field. A minimum of 1 year experience leading and directing the work of others. Excellent knowledge and understanding of pharmaceutical production and quality concepts and procedures is required. Ability to make decisions and implement changes as directed. Must have good written and verbal communication skills and ability to work with all levels of the organization. Previous project management experience is preferred. MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
Ability to lead and manage teams. Ability to communicate effectively both orally and in writing. Ability to develop and maintain cooperative working relationships with others. Strong organizational skills; attention to detail Proven experience successfully manage projects. Ability to resolve issues effectively and efficiently. Strong problem solving skills, critical thinking and root cause analysis. Ability to use good judgment tin order to carry out detailed instructions. Ability to handle a variety of tasks simultaneously Ability to work independently and lead others. Strong computer skills including intermediate to advanced skills in MS Office software. Prefer experience with document control software. Intermediate understanding of KPIs for manufacturing operations. Strong knowledge of cGMP Regulations Part 210/211 and 820 as well as DEA regulations.