Quality Assurance Specialist
Full Time in Brooklyn, NY
Quality Assurance Specialist
Maintain all quality systems and generate associated documents meeting current regulatory guidance and industry standards.
Support all cGMP manufacturing and quality control testing, including documentation related to batch production. Create, revise and manage controlled documents, using Electronic Document Manage System.
Manage, maintain and schedule all equipment qualification and calibration, using a tracking system. Run reports and share information periodically with equipment owners to remind departments of due dates. Prioritize cGMP and GLP projects in support of regulatory filings. Identify needs based on quality risk assessment.
BS/BA in science with 1-3 years Quality Control/Assurance cGMP experience in any area of Pharmaceutical or medical device manufacturing or related industrial experience.
- Support all Quality Management objectives.
- Writes/revise SOPs, protocols, validation plans and compliance documents for cGMP program as directed.
- Assist in set-up of cGMP program for manufacture and QC testing activities.
- Support departmental resource for cGMP programs on a day to day basis.
- Ensure qualification of instruments, equipment, facility, clean rooms and computer hardware - software.
- Sets-up and organizes tracking program for equipment used for cGMP purposes.
- Reviews of batch production records and quality control documentation.
- Assists in performing internal and external audits as required and ensures observations are corrected.
- Set-up and track material flow and material-labeling process to ensure compliance with cGMP program.
- Assist in training staff in area of cGMP/GLP and maintains training records.
Highly Desired Requirements
The ideal candidate will have prior knowledge of workings of an Electronic Document Management System (e.g. Master Control, Trackwise, etc.) to manage all controlled documents. Familiar with change control system, deviations and investigations. Possess an understanding of qualification, preventive maintenance calibration of equipment. Possess high of understanding of cGMP guidelines (FDA, ICH and ISO standards). Knowledgeable in instrument, equipment, facility, clean rooms and software qualification – validation IQ/OQ/PQ. Working knowledge of annual product review and stability study protocols per ICH.
- Able to solves complex, non-routine analytical and manufacturing problems.
- Familiar with qualification and validation plans for facilities, equipment and manufacturing processes.
- Experienced in MS Office products-Excel, MS Word and Power Point.
- Very strong oral and written communication skills.
Working Conditions/Physical Demands
Ability to lift 25lbs over more on a regular basis.
No relocation assistance is provided for this position
EpiBone, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, gender, gender identity or expression, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, EpiBone ,Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
**Qualified applicants, please submit your cover letter and CV for consideration to: email@example.com.