Specialist Quality Operations
Specialist Quality Operations
Responsibilities:
- Supports quality of raw materials, packaging materials, and bulk products used in manufacturing and packaging of drug products in a GMP environment.
- Evaluates analytical data and releases supplier raw and packaging materials that conform to corporate, customer, and regulatory specifications.
- Conducts and reviews deviation investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions. Provides guidance and oversight in identifying root cause and preventative/corrective actions.
- Evaluates and approves changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.
- Evaluates material changes and approves new material qualifications. This includes change control that is internal to Kalamazoo, as well as regulatory or market-driven changes.
- Participates in internal GMP audits and supports customer and regulatory audits.
- Candidate is a member of the work team(s) for B156 or B248, and partners with operations and technical support on continuous improvement projects, floor support needs, and other efficiency improvements.
Technical Skills Required:
- Excellent organizational skills.
- Good communication skills to deal with all levels of customers, both internal and external.
- Demonstrated ability to pay close attention to detail and accuracy.
- Candidate must possess flexibility to respond to constantly changing conditions and priorities.
Education & Experience:
- Requires a Bachelor’s degree in science or related discipline.
- Three to five years of QA/QC experience in a GMP pharmaceutical manufacturing environment are desired.