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Title: Quality Assurance Specialist
Hiring Organization: Connexion Systems & Engineering
Our client is seeking: Quality Assurance Specialist
Compensation, Benefits, and Employment Type
- Duration – 12 months+
- Pay rate: 50-60/hr.
- Job Location: Cambridge, MA
- Job#: bh11977
Description:
The QA Compliance Specialist, within the Quality Operations group, is responsible for the quality oversight of GMP manufacturing and release activities at our Cambridge Manufacturing US. The successful candidate will support daily activities involving compliance with applicable regulations for cGMP requirements. The candidate will perform internal audits; assist in the implementation and execution of QA systems to support compliance and assist in supplier management activities for the site.
Under the direction of the QA Compliance Manager, this position is responsible for the quality oversight of GMP Quality System activities at our Cambridge Manufacturing US. The successful candidate will support daily quality system activities in a commercial setting. The candidate should be expected to leverage training, experience and technical knowledge to all GXP groups on a routine basis, influencing a fast-paced dynamic environment to address quality concerns appropriately. This includes appropriate interpretation and use of existing quality systems and practices.
Responsibilities Include:
- Ensure compliance to local SOPs, global policies and applicable regulations by leading internal audits and walkthroughs
- Liaise between ICMUS and other of our sites globally to ensure operating procedures are aligned
- Support the site Data Integrity Program
- Ensure the site is inspection ready at all times
- Work to identify high risk issues across the site and implement corrective actions
- Work with key stake holders Initiate and support the closure of the Deviations, Change Control’s and CAPA’s
- Assist in supplier management activities such as initiating/ driving closure of Supplier Corrective Action Reports and monitoring/ implementing suppler change notifications (which may include revision of specifications)
- Perform supplier qualifications
- Participate on various project teams as assigned
- Assure that manufacturing operations are in compliance with cGMP regulations
- Support additional QA tasks or projects as assigned
Desired Qualifications:
- BS degree or higher in Biology or Chemistry preferred
- ASQ Auditing Certification in a plus
- 10 + years of experience in a GMP environment
- 5+ years of experience as a lead auditor
- Ability to analyze, trend, report and present data
- Veeva Vault and TrackWise experience is a plus
Candidates must be self-motivated, and have a strong attention to detail with the ability to multitask
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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