Overview
Quality Manager Jobs in Washington, MO at Washington Metal Fabricators
Job Description: Quality Control Manager is responsible for working closely with the Quality Assurance Director to assist in the development and maintenance of Quality Management Systems at VetStem. These systems will ensure the safety, efficacy, and purity of the products manufactured by VetStem. The VetStem manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled clean room facility designed to enable production of regenerative medicine products.
Primary Responsibilities:
Develop and maintain the following systems:
Environmental Monitoring Program management, including monitoring, trending, reporting, and coordination of EM validations.
QC assay Validations/Suitability testing (Management, Protocols and Reporting)
Management of Equipment Calibrations and OOT Response
Management of Raw Material Program (Specification development, inspection, .testing and release..)
QC testing (intermediate and final product release)
Maintain the stability program
Management of the Stability program
Deviation Management including OOS, OOT, and associated investigations, and CAPAs. , Sample management and tracking program
Management of QC Record keeping and archiving
Support QA with the day-to-day management of the following
Reporting and organization of Quality Control test results
Issue batch records and labels
Assist in review of completed records prior to filing in Records Management
Maintain technical report and change control files
Assist in deviation investigations and coordination of corrective and preventive actions (CAPA)
Write and review Standard Operating Procedures
GMP QC compliance in the manufacture of products
Secondary Responsibilities:
Support FDA inspections, internal audits from 3rd parties, and external audits, including completion of customer supplier evaluations and review of supplier agreements
Support production and manufacturing activities as needed
Assist in training of staff on regulatory requirements and internal procedures as applicable
Perform additional job related duties as required
Minimum Requirements:
2 – 5 years of experience in a Quality Control/Quality Assurance role; prior experience within a cGTP/cGMP regulated biotech, cell processing, tissue bank or pharmaceutical company preferred
Demonstrated ability to manage and prioritize multiple projects and meet deadlines
Excellent time management and organizational skills
Strong written and verbal communication skills
Understanding of the fields of aseptic processing, cell therapy and cryopreservation preferred
Exceptional analytical skills and solutions-oriented approach to problem-solving
Ability to work effectively in a fast-paced, rapidly changing environment
Demonstrated ability to work independently as well as part of an integrated team
Flexibility and dedication: Position may require some “off-standard hours”
Direct Report: Quality Assurance Director
Minimum Years Experience: 2-5
Travel: local
Minimum Degree: BS in related field or equivalent experience.
Full-time
Exempt
Salary: Competitive
Job Types: Full-time, Part-time, Contract, Temporary
Benefits:
401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
Monday to Friday
Work Location: In person
Title: Quality Manager
Company: Washington Metal Fabricators
Location: Washington, MO
