5+ years in the pharmaceutical or regulated industry
2+ years of supervisory experience in a team or process
Familiarity with GMPs and ISO standards
Strong problem-solving abilities
Effective communication skills for team management
Proficiency in ERP and QMS systems
Ability to thrive in a diverse workplace environment
Responsibilities
Manage and direct Quality Assurance staff and activities on the production floor.
Ensure compliance with company safety rules and workplace conduct.
Conduct inspections and tests to verify compliance with quality standards.
Provide leadership and make critical decisions for team management.
Create a safe and equitable working environment for all employees.
Oversee supplier quality program for cGMP compliance.
Maintain compliance of quality systems and documentation.
Benefits
Opportunities for career advancement within the company.
Access to ongoing training and professional development programs.
Health and wellness programs to support employee well-being.
Dynamic work environment that encourages innovation and teamwork.
Commitment to safety and a non-discriminatory workplace.
Full Job Description
Description
Responsibilities
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
