What are the responsibilities and job description for the Engineering Process Deviation Writer position at Accuro?
Business Title : Engineering Process Deviation Writer
Location : Cambridge, MA (2nd shift : 3pm - 11pm Monday through Friday)
Job Type : 12 months contract
PARKING IS ROUGHLY $420 / MO
2nd shift : 3pm - 11pm Monday through Friday
We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.
Job Responsibilities :
Execute all activities following quality and regulatory standards and procedures
Promote a quality mindset and quality excellence approach to all activities
Continue support of continuous improvement culture and industrial excellence methodologies
Support employees and respective departments in a manner which is clear in approach, communication, and action
Provide proactive communication to customers to ensure timely escalation and resolution of issues
Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners
Support batch release of drug substance including compilation of documentation, as needed
Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures
Provide on the floor support to Manufacturing
Perform SAP transactions applicable to batch record review
Working knowledge and / or ownership of the following quality systems : Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation
Support GMP compliance and inspection readiness within organization
Assist in coordination of work for the QA Operations team to facilitate timely release of product lots
Perform review in Blue Mountain Ram for calibration, work order activities
Skills & Experience Required
HS Diploma or equivalent and 8 years of experience in a cGMP environment, OR associate degree and 6 years of experience in a cGMP environment, OR bachelor’s degree and 4 years of experience in a cGMP environment.
Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following : batch release, SAP, batch record review
Demonstrated experience in regulatory inspection activities
Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical / biopharmaceutical products for international markets
Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC
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