Quality Assurance Specialist

Proclinical is seeking a Quality Assurance Specialist for a global pharmaceutical company located in Cambridge, MA.

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

Must be eligible to work in the US.

Job Responsibilities:

• Develop and implement quality procedures to ensure compliance with quality assurance standards and guidelines.
• Collaborate with the Local and Global team to ensure consistent project execution.
• Provide Quality Assurance support resolving material issues, CAPAs, DEVs, OOSs.
• Support material release process, including labeling.
• Support SAP implementation including master data creation and data migration.
• Handle site supplier change notification (SCN) intake, facilitating SME assessments and closure.
• Participate in incoming and point of use non-conforming material investigations.
• Support supplier investigation/SCAR management.

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 Raw Material release process operations including some or all of the following: raw material release and labeling, supplier investigations and SAP.
• 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.
• Working knowledge of SAP
• 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.
• 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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