QC Supervisor - Environmental Monitoring​/Metrology

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Quality Control Full-Time, Regular Employee Management-Indirect Verona, WI, US

**$2,000 Sign-On Bonus!*
* QC Supervisor
- Environmental Monitoring/Metrology

1st Shift: 8:00 am – 5:00 pm, Monday thru Friday

Position Overview

The QC Supervisor – Environmental Monitoring and Metrology oversees the Environmental Monitoring (EM), Cleaning Verification/Validation, and Metrology programs within the Quality Control (QC) Department, providing leadership and technical oversight to ensure program activities are performed in accordance with established procedures and applicable cGMP requirements. Activities performed within these programs include environmental sampling, testing, investigations, and trending; cleaning method development and validation, routine cleaning verification, equipment cleaning validation, and campaign length validation;

and equipment calibration, maintenance, qualification, and applicable laboratory software validation and lifecycle management.

This position will participate in client/regulatory on-site audits for Coating Place and must have a thorough understanding of Internal procedures, and USP, ICH and FDA guidelines as they relate to Environmental Monitoring and Cleaning Validation requirements, equipment, software, and general laboratory functions.

Essential Job Functions

• Supervises, mentors, and develops EM, Cleaning Validation, and Metrology personnel, including assigning and prioritizing work, monitoring performance, conducting routine meetings, and completing employee performance evaluations
• Establishes work priorities, coordinates resources, and communicates status, technical issues, and program performance to internal and external stakeholders, as appropriate
• Collaborates with Production, QC, and QA personnel to coordinate and prioritize cleaning verification activities, resolve technical issues, and minimize interruptions to manufacturing operations
• Assesses new project risks and leads cleaning/campaign length validations and cleaning verifications
• Oversees the calibration, preventive maintenance, and qualification of laboratory equipment, ensuring activities are appropriately scheduled and prioritized.
• Drafts, reviews, and approves SOPs, protocols, trend reports, and other technical documentation related to each program
• Participates in on-site client and regulatory audits
• Maintains knowledge of applicable regulatory requirements, industry standards, and best practices related to environmental monitoring, cleaning validation, metrology, and equipment qualification.
• Follows all Coating Place cGMP practices, policies, and procedures.
• Follows all Coating Place safety practices, policies, and procedures.
• Employees at Coating Place work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Education/Skills/Knowledge Required

• Bachelor’s degree in microbiology, chemistry, or other related field.
• 3+ years of supervisory experience in a pharmaceutical environment or a minimum of 5+ years of experience at Coating Place, Inc or applicable cGMP environment. An advanced degree may be substituted in place of experience.
• Thorough knowledge and understanding in the use, methodology, and troubleshooting of analytical and/or microbiological equipment.
• Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities.
• Proven demonstration of leadership skills to successfully train, direct, and motivate QC personnel required.
• Advanced time management skills to complete assignments/projects in a timely manner with minimal supervision.
• Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.

Competitive Benefits:

• Medical, Dental, Vision, Life, AD&D, and Disability Insurance
• 401K Plan
• Tuition Reimbursement Program
• Paid-time Off
  - Accrue up to 17 days of PTO within the 1st year!