Senior QA Specialist

Proclinical is seeking a Senior QA Specialist for a global biotech company located in Cambridge, MA.

In this role, you will be responsible for overseeing the quality assurance process, supporting batch disposition of drug substance, ensuring that our products meet both Local and Global quality standards.

Must be eligible to work in the US.

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 and review of batch documentation (i.e. batch records, deviations, in-process EM)
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Support SAP integration and master data migration for batch release activities
• 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.

Skills and Requirements:

• 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
• Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
• Demonstrated experience in regulatory inspection activities.
• Ability to work on multiple projects on a tight timeline.
• Ability to prioritize and the flexibility to adapt to changing priorities.
• Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
• SAP knowledge
• Experience working successfully both independently and in a team environment.
• Strong verbal and written communication skills.
• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC.
• Able to prioritize and decide appropriate course of actions.
• Root cause analysis experience preferred.
• Vaccines experience a plus.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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