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QC Lab Manager

Location: 

DOVER, DE, US

Req ID:  820
Job Type: 

We are a global team of 6000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

 

 

Position Summary

Plans, organizes and directs the essential functions of quality control activities in support of plant production.  Coordinates the day to day quality control activities of the laboratories in regards to testing of raw materials, in process , and finished goods.  Reports to the DIrector Femcare Quality and collaborates closely with the Managers of Quality Assurance, Manufacturing, Planning, Engineering, Warehouse, and R&D.

 

Universal Accountabilities

 

  • Ensure Quality Control Laboratories comply to FDA regulations.
  • Participating in establishing laboratory objectives with Supervisors.
  • Utilize computer systems for managing activities related to the quality control laboratories (Success factors, SAP, MII, Minitab, PLM, Agile, Microsoft, etc.).
  • Motivate the team and provide strong coaching and mentoring to direct reports.
  • Minimize the risk and exposure to non-conformances, out of specifications conditions, and compliance gaps.
  • Oversees and approve all quality control laboratory investigations.
  • Conduct audits of the Quality Laboratory System.
  • Plans, executes, and evaluates continuous improvement in quality and process control.
  • Assures that corrective actions are taken to eliminate the causes of non-conforming product.
  • Determines and reports the principal cause of failures and non-conformance.
  • Ensures all laboratory equipment that is used for testing in the laboratories is maintained and calibrated.
  • Ensure all quality control laboratory staff is properly trained and qualified.
  • Ensuring that documentation in the laboratories is in accordance to good documentation practices.
  • Manage the quality work environment (office areas, set guidelines for laboratories, establish work hours, dress attire, housekeeping standards, etc.).
  • Attend leadership meetings to represent the quality control group.
  • Escalate quality issues to senior manager and leadership team in accordance to corporate procedures.

 

Specific Accountabilities

  • Directly supervises quality control supervisors and staff.
  • Quality Management Representative for government regulators and internal audits.
  • Provides input and manages against a planned budget.
  • Manages analytical testing activities in the laboratories
  • Manages activities related to incoming Inspection and testing of raw materials and components
  • Manages activities related to product performance testing to support final release of finished devices
  • Manages calibration program for production, QC, and R&D inspection, measurement, and test equipment
  • Manages activities related to environmental monitoring in controlled environment
  • Ensures data integrity with all reports and testing
  • Ensures all equipment in the laboratory are qualified.
     

Required Skills and Experience

  • BA or BS in a technical discipline such as Biology, Chemistry, Engineering, Microbiology or related field or equivalent experience. 
  • Minimum of 10 years of experience in quality related jobs, 10 years of experience in laboratory, with 5 years in supervision.
  • Strong interpersonal skills.
  • Strong verbal/written communication.
  • Strong organizational, prioritizing and follow up skills; attention to details.
  • Ability to handle multiple tasks/projects simultaneously and display a sense of urgency.
  • Ability to work well under pressure, with minimal to no supervision, meets deadlines, and interacts with a variety of personnel and contacts.
  • Ability to think and act, with minimal supervision, to make decisions.
  • Knowledge of laboratory techniques and good laboratory practices

 

Preferred Skills and Experience

 

  • Working knowledge of FDA 21 CFR part 820, 210 and 211 requirements.
  • Working knowledge of Canadian Medical Device Regulations SOR/98-282
  • Working knowledge of ISO 13485 and 14971 requirements
  • Thorough knowledge of regulatory requirements and limitations.
  • Working knowledge of FDA regulated products.
  • Working knowledge of validation activities for equipment.

 

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Edgewell is an equal opportunity employer, and we prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any other legally protected status in accordance with applicable federal, state and local laws.

 

 


Nearest Major Market: Delaware
Nearest Secondary Market: Dover