In Process Quality Assurance (IPQA) Specialist, Nebulizer (2nd Shift)
Job Description
POSITION SUMMARY:
This position will be responsible for working closely with the Glenmark Blow Fill Seal Operations organization supporting operation activities during manufacturing, packaging, validation, cleaning verification, etc. Assisting in the development and implementation of a harmonized processes and systems. Responsibilities within SAP will include Incident, Deviation, CAPA, Change Control initiation, raw material release. This position will also help evaluate, manage and document changes pertaining to operations and In-Process Quality Assurance (IPQA). This position will actively participate in global procedure harmonization and other Quality projects as needed.
MAJOR RESPONSIBILITIES:
QUALIFICATIONS:
Minimum Associate’s degree in scientific discipline or closely related technical field of study is required.
1-3 years of pharmaceutical and FDA is preferred.
Previous experience on the floor in Manufacturing (Dispensing, Solution Prep, vial filling, blow fill seal filling, pre-filled syringes, Inspection and Packaging, etc.
Understanding of the production processes used in the Pharmaceutical Industry.
GMP experience is required.
Previous Quality experience is preferred.
Working knowledge of Lean, Six Sigma, 5S
Excellent verbal and written communication. Must be able to read, write, and speak English.
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) and/or SAP (Systems, Applications & Products in Data Processing) or similar ERP systems is a plus.
Good communications skills, front runner, GMP trainer a plus.
Any quality certifications a plus
WORK SCHEDULE
2nd Shift Monday - Friday 1500 to 2330 (3:00 PM -11:30 PM)
Our Company is an Equal Opportunity Employer committed to fostering diversity in the workplace, both in its employee workforce and in Company leadership. (minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity)