DescriptionResponsibilities- Manage, plan, organize, direct, and evaluate all activities and QA staff to ensure that Quality support is present on the production floor and assistant in resolving compliance concerns
- Comply with all company safety rules and workplace conduct requirements
- Inspect and test materials, equipment, processes and final products to verify compliance with quality standards
- Provide strong leadership, project and people management skills, and critical decision-making abilities
- Assure a safe and non-discriminatory working environment for employees
- Ensure compliance with manufacturing, specifications, and company policies. Ensure the departmental SOPs are current and staff are trained on relevant activities
- Manages the supplier quality program to ensure cGMP compliance over vendors that provide materials/services
- Ensure GMP compliance of quality systems/tools used at the site including a quality manual, policies, procedures, and work instruction documentation that make up the hierarchy of the Document Control system
- Maintains metrics program with measurables that achieve continuous improvements of processes and procedures
- Prepare the department for both internal and external authorities during audits ensuring facility is always audit ready
- Responsible for change control activities/documentation in QMS. Required to perform review of submission documents
- Ensure deviations and non-conformances are initiated, investigated, and closed
- Support approval of manufacturing documents (SOP's/WI, Forms)
- Manage relationship with Third Party Testing Labs, Equipment Vendors and Calibration Suppliers
- Demonstrate a deliberate focus on Safety, Quality, Continuous Improvement, and Customer Satisfaction
Qualifications/Skills Required- 5 + Years' experience in pharmaceutical, packaging, or similar regulated industry
- 2+ years direct/indirect supervisory experience and/or leading a team or process
- Working knowledge of GMPs, ISO standards and production processes
- Ability to work autonomously applying strong problem-solving skills
- Strong communication skills are needed to manage support personnel
- Ability to navigate through our ERP and QMS systems effectively
- Ability to work well with others and in a diverse workforce environment
- Must be eligible to work in the United States without restriction
Physical Requirements- Safely and effectively handle objects weighing between 15-20 pounds on a consistent basis, with the capability to lift up to 50 pounds when required
- Maintain good hand-eye coordination and manual dexterity
- Sustain physical endurance for a fast-paced work environment
Operate and work near machinery safely
