This candidate will be responsible for ensuring the Quality systems at CRD are designed appropriately, properly implement and correctly carried out.
Main Duties & Responsibilities
- Provide leadership, coaching and training for Production and Quality departments by having an active presence on the production floor.
- Ensure written procedures and documentation are correct and being properly followed.
- Schedule and conduct internal audits and report findings to applicable area management and Quality management.
- Conduct material and process issue investigations and determine proper escalation procedures.
- Participate in implementation of Corrective and Preventive Actions (CAPA) as related to quality department.
- Issue, track, trend and close out of internal Non-Conformance Reports (NCRs).
- Interface and coordinate customer visits (when related to quality functions).
- Lead quality improvements projects, efforts, and directives.
- Understand HACCP principles and lead efforts to ensure HACCP plan is followed.
- Lead mock and actual product trace during audits, or as required.
Requirements
- BA or BS in life sciences from an approved institution preferred.
- At least 3 years’ experience in a federally regulated industry, preferably nutraceutical or pharmaceutical.
- Certified Quality Engineer through ASQ preferred.
- Experience in a manufacturing and/or contract manufacturing environment preferred.
- Excellent interpersonal, written and communication skills.
- Working knowledge and experience with Microsoft Office.
- Must have team-building and leadership skills.
- Ability to resolve and handle difficult challenges and issues in a timely manner.
- Ability to be confidential.
- Ability to deal with periodic levels of highly stressful situations associated with handling difficult issues and challenges.
- Must be able to understand, speak, read and write in English in order to perform the essential functions of the job as they relate to comprehension of laws, regulations, standards, documents and other internal and external communications.
Work Conditions
- Subject to a rapid paced production environment.
- Subject to moderate noise levels.
- Subject to atmospheric conditions, such as fumes, odors, powders, dust and other particles.
- Ability to work various shifts and overtime as required.
- Ability to work standing up for long periods of time
