QA Specialist - 2nd Shift

Location

Cambridge, MA | United States

Job description

We are seeking a highly skilled and experienced Senior QA Specialist to work the second shift 3pm - 11:00 PM to join our team. In this 2nd shift role , you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.

Responsibilities:

• CSV - Computer Systems Validation programming - a Must.
• 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
• 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
• 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.

Qualifications: We are looking for professionals with these required skills:

• Ability to work second shift - 3pm - 11:00 PM.
• 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, batch record review.

Preferred Qualifications: If you have the following characteristics, it would be a plus:

• 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.

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!

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Salary