The
Quality Supervisor is responsible for supervising the operations of all quality related aspects within the Quality department throughout daily operations ensuring compliance with current Good Manufacturing Practices. This role provides direct supervision of quality personnel, supporting production activities, drives continuous improvement initiatives. This individual will have a team of direct reports. This role reports directly to the Quality Manager.
Location: Irving, Texas
OpportunityResponsibilities & Duties:QualityMaterial Inspection and Release Process
- Oversee the inspection and release process of incoming material.
- Support the technical inquiries with external third party testing laboratories.
- Coordinate sampling activities
Review and Approval of Standard Operating Procedures
- Collaboration on MEDISCA's Standard Operating Procedures.
- Ensure Standard Operating Procedures are aligned with external regulations that govern the compounding industry.
Production Process
- Oversee the production activities related to re-packaging processes.
Quality Events
- Perform and support deviation investigations, non-conformance material report (NCMR) and corrective and preventative actions (CAPA) investigations as applicable.
- Identify scientifically sound root causes and implement robust CAPAs.
Environmental Monitoring and Equipment
- Oversee the environmental monitoring program in the facility.
- Oversee the equipment calibration and maintenance program.
Quarantine
- Maintenance of quarantine, rejection, rework and return to supplier areas.
- Periodically review all materials within and ensure timely dispositions are occurring.
Change Control Process
- Support the change control process related to the Quality department.
- Collaborate in the quality assessment CRs and provide comprehensive feedback.
Quality Metrics
- Generate the KPIs related to the performance of the team.
- Collaborate to the continuous improvement in the department.
People Leadership
- Ensure team members understand and follow cGMPs and MEDISCA policies and procedures.
- Lead members of your team; guide them to perform at their best. Set and manage clear targets and KPIs and monitor progress.
- Foster a high driven culture within your team by empowering them to bring their best selves to work.
Qualifications- Bachelor's degree or higher in Science
- 3-5 years in quality and/or Regulatory Affairs
- Knowledge of cGMPs, 21 CFR Part 211, GUI-0104, GUI-0069; ICH Guidelines; ISO 9001; ISO 13485.
- Previous experience in supervision and/or management, with a strong leadership presence.
- Excellent communication skills required; fluent English & French (oral & written). This position interfaces with facilities in the Unites States and Australia.
- Analytical, with the ability to make data & people driven decisions.
- Great time & project management skills.
- Very good command of Microsoft Office (Word, Excel, Outlook)
- Experience with MasterControl is a strong asset
What's in it for you... We invest time and resources into making sure Medisca is as good as the people we hire.
- Work/Life Balance - PTO, vacation policy and paid statutory holidays
- Invest in your health - Group Benefit plan and health savings account
- Your Future is Bright - Opportunities to learn and grow within Medisca
- Save for your Future - Medisca contributes to a 401k plan when you invest in the plan
- Help us grow - Employee Referral Program
- We like to have fun - company events throughout the year
- Full time positions - 40 hour work week
- Your safety is important - Medisca provides an allocation to purchase safety shoes
- Company is growing - new state of the art facility, coming soon
We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
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