What are the responsibilities and job description for the Quality Manger position at Share Corporation?
Athea Laboratories, a leader in specialty chemical product manufacturing, is seeking a Quality Manager.
The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the Company's Quality Management System (QMS) to ensure compliance with applicable regulations, customer requirements, internal standards, and industry best practices. This person supervises other quality department personnel.
This position provides leadership for quality-related activities, promotes a culture of quality throughout the organization, and partners with cross-functional teams to ensure products are manufactured, tested, and released in accordance with established specifications and regulatory requirements. The Quality Manager is responsible for oversight of quality systems, investigations, corrective and preventive actions, internal audits, customer quality matters, and regulatory inspection readiness.
This position requires local travel between facilities located in Milwaukee, WI.
Key Responsibilities:
- Manage and maintain cGMP program where required
- Manage document control processes, including creation, review, approval, revision, distribution, and retention of controlled documents and records
- Conduct and oversee investigations of deviations, nonconformances, complaints, and other quality events
- Plan and perform internal audits and monitor corrective actions resulting from audit findings
- Oversee quality-related regulatory inspections, customer audits, and third-party assessments, including preparation of records and responses
- Review and approve quality-related documentation, including batch records, specifications, change controls, and validation documents, as applicable
- Manage quality training programs and maintain training records as required
- Provide quality-related guidance and support to Manufacturing, Regulatory Affairs, Operations, Research and Development, and other departments
- Personnel management and supervision (candidate screening and interviewing, conducting personnel performance reviews, corrective action)
- Oversee and document production process validations where required, including IQ/OQ/PQ
- Oversee the inspection, calibration, maintenance of laboratory equipment
- Evaluate, qualify, and audit raw material suppliers
- Evaluate and interface with outside laboratories and vendors
Other Responsibilities:
- Lead or collaborate on special projects as assigned
- Identify and implement ways to streamline processes and improve efficiency (e.g., digitizing processes)
- Oversee and manage the retention and disposal of physical retains
- Providing backup coverage to the QA/QC Supervisor for immediate production needs
Qualifications & Skills:
- B.S degree in a scientific field is required.
- 7 years of experience overseeing quality in a manufacturing environment. Experience working within a heavily regulated industry such as food or pharmaceuticals is strongly preferred
- One or more relevant professional certifications is preferred
- Expert-level proficiency with Microsoft Office Suite. Experience with enterprise resource planning software is required.
- Working knowledge of Lean Manufacturing principles and tools is preferred
- Bilingual (Spanish) is preferred
- Strong written and verbal communication skills
- Strong project management and organizational skills
- Strong attention to detail
- Strong interpersonal and leadership skills
- Strong critical thinking and problem-solving skills
- Strong analytical and mathematical skills
- Ability to wear required personal protective equipment (e.g., lab coat, chemical-resistant gloves, protective footwear, eye protection)
- GMP facility – any jewelry or piercings must be able to be removed or covered
Company Information:
- Athea Laboratories is a manufacturer of wet wipes and chemicals used in industrial, institutional, and retail marketplaces.
- Established in 1965, Athea is a family-owned business that continues to see exceptional growth and opportunity in the markets we serve.
Athea Laboratories is an Equal Opportunity Employer and is committed to providing a workplace free of discrimination and harassment. All employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws. Athea Laboratories is also committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and employment process. Employment with Athea Laboratories is at-will, meaning that either the employee or the Company may terminate the employment relationship at any time, with or without cause or notice, in accordance with applicable laws. Athea Laboratories maintains a drug-free workplace, and offers of employment may be contingent upon successfully passing a pre-employment drug screening and background check, where permitted by law. Athea Laboratories participates in E-Verify to confirm the employment eligibility of all newly hired employees.