Quality Manger

Share Corporation•Milwaukee, WI

3d•Hybrid

About The Position

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.

Requirements

B.S degree in a scientific field is required.
7+ years of experience overseeing quality in a manufacturing environment.
Experience with enterprise resource planning software is required.
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)

Nice To Haves

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.
Working knowledge of Lean Manufacturing principles and tools is preferred
Bilingual (Spanish) is preferred
GMP facility – any jewelry or piercings must be able to be removed or covered

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
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