Quality Assurance Manager

MAX Solutions; Concord (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

MAX Solutions, Inc. is seeking a highly skilled Quality Manager for our Concord, NC location to lead QA activities on the production floor. You will plan, direct and evaluate QA programs, ensuring compliance with site and corporate standards and driving continuous improvement.

You will report to the Vice President, Quality Assurance and partner with production, regulatory, and supplier teams to maintain quality, safety, and lean processes. Travel up to 5% may be required.

Qualifications

• Bachelor’s Degree in science preferred or equivalent.
• 5+ years in pharmaceutical, packaging, or similar regulated industry.
• 2+ years supervisory experience.
• Working knowledge of cGMPs and ISO standards.
• Ability to work autonomously with strong problem-solving.
• Excellent communication to manage support personnel.
• Experience navigating CERM and QISS systems.
• Must be able to lift up to 35 lbs.
• Willing to work overtime, including weekends.
• Must be eligible to work in the United States without restriction.

Responsibilities

• Lead and evaluate QA staff on production floor.
• Maintain documentation and proper SOPs.
• Ensure compliance with site and corporate standards.
• Improve safety, quality, and continuous improvement.
• Manage supplier quality program for cGMP compliance.
• Maintain QA metrics and audit readiness.
• Support audits by internal and external authorities.
• Assist in change control in QMS.
• Resolve deviations and non-conformances promptly.
• Coordinate with production to improve quality and efficiency.

Skills

Bachelor's Degree

5+ years pharma/packaging exp

Supervisory experience

cGMP knowledge

ISO standards knowledge

Problem-solving

Communication skills

ERP/QMS: CERM & QISS

Physical ability 35 lbs

Willing to travel

Overtime flexibility

Education

Bachelor’s Degree in science

Tools

CERM (ERP)

QISS (QMS)

Job description

Founded by industry veterans Marc Shore and Dennis Kaltman, Max Solutions seeks to impact our customers, employees, communities and the environment through specialty packaging solutions that support the healthcare and consumer segments. We deliver this unmatched impact by investing in next-generation technology, building and supporting an exceptional team of people and never placing limits on creativity.

We are looking for a highly skilled, detail-oriented Quality Manager for our location in Concord, NC.

You will manage, plan, organize, direct, and evaluate all activities and QA staff to ensure that Quality support is present on the production floor. Necessary and critical functions include but are not limited to documentation review and issuance along with prompt resolution and Quality oversight over production ensuring compliance with site and corporate standards. You will support to improve safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant goals. You will make important decisions in ensuring the deviations are investigated, alerts resolved, complaints examined, and product dispositioned promptly. You will report to the Vice President, Quality Assurance.

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

Qualifications/Skills Required

• Bachelor’s Degree in science preferred or combination of education and working knowledge
• 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

Max Solutions, Inc. is an equal opportunity employer and expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, or veteran status, or any other basis that is protected by federal, state or local law.