Quality Control Manager

The person filling this position will provide strategic direction, technical expertise, and leadership for MCP’s Production QC, Analytical QC, Incoming QC, and Industrial Quality (IQ) Groups within the Quality Control Department and aim to ensure that the products and services provided by MCP are fit for purpose, are consistent, and meet both external and internal requirements. This includes legal & regulatory compliance as well as compliance with customer and internal expectations.

Department: Quality Control

Reports to: Director of Quality and Regulatory

We are proud to be an EEO employer, maintain a drug-free workplace and perform pre-employment substance abuse testing.

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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To ensure accurate and efficient analytical laboratory operations with adherence to Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP)

To ensure accurate and efficient production line Quality Control operations with adherence to cGMP and Good Documentation Practices

To oversee and ensure timely and appropriate release of Bulk Formula (BF) batches and Work-in-Process (WIP) and Finished Goods (FG) lots

To ensure proper and timely review of production and QC lot paperwork, and to provide training, supervision, and leadership to Analytical QC, Production QC, Incoming QC, and IQ staffs

Stop the manufacturing or production of material or any plant operation at any time the quality, safety, or integrity of the product or the safety of personnel is jeopardized, or believed to be in jeopardy

Accept, Reject, or place into a “hold” or “quarantine” status any RM or Packaging Part lot, BF batch, or WIP or FG lot based on written and/or visual specifications and assign dispositions to rejected or quarantined materials

Hire, counsel, discipline and separate QC staff as applicable

Set Department schedules based on needs

Delegate responsibilities to Supervisors / other departmental staff as appropriate and warranted

Ensure and enforce QC, cGMP, GLP, and/or Good Documentation Practices and other regulatory guidelines and company policies and procedures

Initiate, investigate, & close Nonconformances, Deviations, Out of Specification (OOS) Investigations, and Corrective & Preventive Actions (CAPAs)

Act in the stead of the Director of Quality and Regulatory (DoQR) as needed in absence of the DoQR with appropriate consultation with other Senior Level Staff (SLS) members

Analytical physical, chemical, microbiological, and instrumental testing methods and best practices

Laboratory record-keeping requirements, best practices, and Good Documentation Practices

General chemical and biological properties and associated hazards, safe handling procedures, and personal protective equipment

Quality Control and Lean Manufacturing/TPS/Six-Sigma principles and best practices as they relate to QC

Reading, interpreting, and applying written and visual production and quality control standards

Personnel management and coaching

Managing the day to day operations of the QC Department within the Quality and Regulatory Directorate

Manage, plan and direct the Analytical QC, Production QC, and Industrial Quality functions to provide the highest quality analytical support for Production Operations while ensuring compliance with protocols, cGMP, GLP, Good Documentation Practices, and safety regulations

Manage, plan and direct the Incoming QC function to provide the highest quality support for Planning, Logistics, and Production Operations while ensuring compliance with cGMP, Good Documentation Practices, and safety regulations

Creating, developing, and maintaining good working relationships with appropriate outside testing laboratories

Ensuring that positions within the groups under direct control are filled with qualified individuals

Handling all administrative tasks involved with salaried QC staff and ensuring that such tasks for hourly personnel within the QC Department are handled by appropriate…