Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 4/24/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Quality Assurance Specialist
Location: Boston, MA 02108
Employment Type: Full Time, Contract to Permanent
Pay Range: 36-38/hr.
Duration: Contract to Permanent
Quality Assurance Specialist
-They are looking for someone with roughly 3-5 years of experience
-Must have GMP experience
-Ideally someone who has experience working in a Biopharma manufacturing environment
-As a QA Spec. one really needs to be an investigator and show evidence from their career that they have performed really in-depth analysis because this is a vital aspect in being able to perform well at this job.
The Quality Assurance Specialist - Operations is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides oversight of production activities with limited supervision.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
- Oversight (with limited supervision), 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 and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
- Disposition of controlled materials (Work in Progress, Finished Product, and Raw 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 and objectively make decisions with support of management.
- 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.
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776