MAX Solutions · 4 hours ago
Quality Assurance Manager
Concord, NC
Full-time
Onsite
Mid, Senior Level
5+ years expMax Solutions is a company focused on delivering specialty packaging solutions for healthcare and consumer segments. They are seeking a highly skilled Quality Assurance Manager to oversee all QA activities, ensuring compliance with corporate standards and leading a team to improve safety and customer satisfaction.
Packaging Services
Hiring Manager
Kristy Thompson
Responsibilities
Comply with all company safety rules and workplace conduct requirements
Will provide strong leadership, project and people management skills, and ability to make critical decisions
Willing to learn new aspects of the business
Hire and retain great talent, develop, and provide challenging work for team members; support the career development of their employees. Manage people performance, maintain performance records, and development
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 trained on activities being performed
Manages the supplier quality program to ensure cGMP compliance over vendors that provide materials/services for the site
Ensures 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
Provide necessary floor support to the production teams and help in resolving compliance concerns
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)
Participate / lead teams which impact production, increase efficiency, solve problems, create cost savings, improve quality, and provide new product support
Manage relationship with Third Party Testing Labs, Vendors of Equipment and Calibration, suppliers
Performs other job duties as assigned
Qualification
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 cGMPs, ISO standards and production processes
Ability to work autonomously applying strong problem-solving skills
Strong communication skills are needed to manage support personnel
Can navigate through CERM (ERP) and QISS (QMS)
Must be able to lift, push, pull and carry up to 35 lbs
In general, you will do a combination of sedentary work and walking around observing conditions in the facility
5% travel
Must be able to work with and around inks, solvents, and other chemicals
Willingness to work overtime when needed, including weekends
Ability to work well with others and in a diverse workforce environment
Must be eligible to work in the United States without restriction
Preferred
Bachelor's Degree in science preferred or combination of education and working knowledge
Company
MAX Solutions
Max Solutions aims to make a difference in the lives of its customers, employees, communities, and the environment.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-11-11Seed
Leadership Team
Dennis Kaltman
President/COO
Company data provided by crunchbase