Quality Assurance Specialist
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The Quality Assurance Specialist I - Operations is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides real-time review of production activities.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Real-time review of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
- Review and approval of Materials Management and Supply Chain activities
- Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
- Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
- Initiation of Discrepancies, including Deviations and Investigations.
- Support of implementation of CAPA as determined through Discrepancies
- Review of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
- Disposition of controlled Raw Materials and Work in Progress materials
- Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
- Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
Education and/or Experience:
- Bachelor’s degree in a scientific discipline is required, preferably in physical Science or Chemistry.
- Minimum of 3-5 years of progressive experience in a GMP environment required.
- Minimum of 1 year of Quality Assurance experience in support of GMP production required.
Supervisory Responsibilities: None
- Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
- Previous exposure to investigations and product complaints preferred.
- Must be able to interpret applicable standards.
- Must be proficient in MS Office Suite.
- Experience in the use of Material Requirements Planning (MRP) systems preferred.
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
- Excellent verbal and written communication skills.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Ability to work both independently and in a collaborative team setting.
- Ability to accept multiple tasks and adjust priorities, as assigned.
- Demonstrated ability to stay abreast of trends and new information in the profession.
- Excellent organizational skills and attention to detail are required.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.