GMP Specialist is responsible for ensuring quality oversight of our manufacturing process of product formulation. The individual will work closely with product development and the manufacturing team. Ensure quality oversight is phase appropriate and scale-able in a timely manner. Position requires expertise in all aspects of product manufacturing, ability to work hands on, strong leadership skills, and the ability to collaborate in a cross-functional environment.

ESSENTIAL FUNCTIONS:

Include the following. Other duties may be assigned.

·       Lead and conduct area daily site walk-throughs for GMP potential concerns; and subsequent reporting and tracking to closure.

·       Conduct weekly facility walk through evaluations with facility maintenance

·       Real time auditing of site processes to ensure SOPs, logbooks, forms and MBR are being completed accurately.

·       Support assigned investigations site wide.

·       Jointly responsible for CAPA development with and implementation of action plans at Akorn Somerset

·       Assures area management is accountable for compliance at all times with direct, independent reporting relationship to site head

·       Conducts real time GMP training.

·       Assists management regarding follow ups on all related Operational findings from FDA, other regulatory bodies, contract customers, internal audits, etc.

·       Room checklist and logbook program support in accordance with approved SOP’s.

·       Report out at site Operational meetings.

·       Special assignments from site head relating to GMP compliance

·       Standing member of site Technical Review Board.

EDUCATION AND EXPERIENCE:

Bachelor Degree in Scientific Discipline or equivalent combination of education and experience

5 years minimum work experience in Aseptic Manufacturing for a FDA regulated facility