Director Quality Assurance Quality Control
RH Digisoft Technical Services, st. louis, mo, United States
Provides management of the Quality Assurance and Quality Control functions as it supports production in a chemical manufacturing facility.
ESSENTIAL DUTIES AND RESPONSIBILITIES include, but are not limited, to the following:
- Leads organization with internal quality activities and all associated external quality relationships with vendors, customers, regulatory agencies, etc.
- Leads CAPA and Internal Audit activities.
- Investigates and determines corrective actions for off-spec materials, customer complaints, supplier non-conformances.
- Leads QST and Management Review Meetings.
- Directs Quality System maintenance needs to the organization.
- Supervises QC Technicians.
- Manages preventive maintenance of laboratory equipment and inventory of laboratory supplies.
- Manages internal/external outside calibration services for critical measuring equipment.
- Assists purchasing in resolving quality-related issues originating with the vendor.
- Acts as Quality Management Representative during all quality, regulatory and customer audits.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- Four year degree in a scientific discipline or equivalent combination of education and experience.
- Computer proficiency using Windows/Word/Excel/Outlook.
- Knowledge of quality management systems such as ISO-9001 and/or regulatory experience with FDA (medical device), EPA (pesticide registration), DOT and OSHA are a plus.
- 5-10 years experience working in a cGMP/QSR/ISO-9001 environment.
- 3-5 years experience in managing a quality system