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
Job details are sourced from the employer's original posting.
