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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Please email your resume to: CPrice@mcp-mail.com

 

Supervisory Duties:

  • 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

Duties & Responsibilities:

  • 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 Supervisory personnel

  • Ensuring that the resources of the QC functions including, but not limited to, consumables, equipment, and overtime are utilized appropriately and efficiently to reduce waste and maximize safety, productivity, and efficiency

  • Monitoring and managing individual growth of staff through collaborative growth plans for each employee

  • Monitoring departmental morale, and taking / recommending steps for improving morale

  • Establishing open lines of communication for routine information dissemination and open discussion of events with staff

  • Acting as back-up for Supervisory personnel under direct reporting structures due to absence / work over-load

  • Providing job-specific training to and performing periodic evaluations of salaried/exempt QC staff to demonstrate and document mastery of skills and integrity in their work and assist salaried QC staff to do the same for their direct reports

  • Providing Subject Matter Expert (SME) knowledge/research resource (as needed and appropriate to educational and experiential level) for Regulatory and Quality matters

  • Writing, reviewing, and/or approving documents including, but not limited to, Standard Operating Procedures (SOPs), Analytical Testing and FG Specifications, and Work Instructions (WIs), and forms, logs, and training materials (as necessary) for such documents

  • Developing, maintaining, and improving systems to ensure that all measuring and analytical equipment assigned to and used by QC staff is properly maintained and calibrated as required

  • Developing, maintaining, and improving systems for development, transfer, validation, and implementation of analytical test methods (both compendial and customer-provided)

  • Assisting with Analytical and/or other QC aspects of validation protocols

  • Executing and approving all Analytical QC Out-of-Specification (OOS) laboratory investigations

  • Acting as Lead or Associate Investigator and/or providing inspection, analytical, or other support as required for Nonconformance (NC), Deviation, and/or Corrective and Preventive Action (CAPA) investigations

  • Enforcing compliance with company policies, cGMPs, and regulatory requirements plant-wide

  • Reviewing and analyzing QC and Operations related metrics and reports and recommending / undertaking appropriate corrective measures regarding productivity and efficiencies

  • Performing periodic review of data generated by Analytical QC, generating data figures and trends, and evaluating and presenting those and other results to MCP’s Senior Level Staff (SLS)

  • Ensuring compliance with company policies and objectives and cGMPs by performing / assisting with both announced and unannounced internal audits of company departments and systems

  • Assisting the Director of Quality and Regulatory as a primary resource during outside audits and regulatory inspections

  • Leading strategic, budgetary, and departmental growth and development planning for the QC Department and assisting/advising the Director of Quality and Regulatory with same for the Quality and Regulatory Directorate as a whole

  • The above duties and responsibilities are representative of the nature and level of work assigned and are not necessarily all-inclusive


Required Skills & Abilities:

  • Team player and able to build and maintain relationships both internal and external

  • Flexible to change and open to constructive feedback

  • Ability to draw conclusions from data and communicate those conclusions verbally and in writing

  • Technical aptitude and advanced problem-solving skills

  • Excellent written and verbal communication skills are essential

  • Strong organizational and interpersonal skills

  • Able to work independently and manage personnel and resources with minimal supervision


Education & Experience:

  • Minimum of a Bachelor of Science degree in Quality, Science, Engineering, or other appropriate field or equivalent analytical or QC experience

  • Minimum of five (5) years’ experience in analytical and/or microbiological bench-level laboratory work and/or QC in a manufacturing environment

  • Minimum of three (3) years’ managerial experience, five (5) years’ supervisory experience, or appropriate combination

  • At least Intermediate computer skills (e.g. MS Office including Excel and Word) are essential

Physical Requirements:

  • Prolonged periods of siting at a desk and working on a computer

  • Must be able to lift up to 15 pounds