The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in Baltimore on their quest for a talented Quality on the Floor Manufacturing, Specialist. In this role, you will provide QA oversight of manufacturing processes via real-time audits, as well as write and revise documentation.
- Real-time batch record review, disposition, and in-process auditing.
- Walkthroughs of GMP areas to ensure inspection readiness of facility.
- Write and revise SOPs.
- Review and approve CGMP documents, such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures.
- Write, review and assesses deviations, closure of CAPAs, Gap Analysis and Product Complaints.
- Implement solutions for manufacturing operations.
- BS or BA degree in Science or Engineering.
- 5-10 years’ GMP experience.
- Strong experience performing on the floor audits, real-time GMP document review, and closure of CAPAs.
- Experience authoring and revising SOPs, reviews, and deviations.
Specialist, Analyst, QOTF, on the floor, GMP, batch record review, audit, facility, SOP, deviations, CAPA.