QA Specialist 3rd Shift
Posted on: November 19, 2023
QA Senior Specialist
Monday through Friday- Onsite- THIRD SHIFT
Must be USC/GC Holder, NO C2C
Pay range: $50hr-$55hr
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.
--- Execute all activities following quality and regulatory
standards and procedures.
--- Promote a quality mindset and quality excellence approach to
--- 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
--- 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
--- 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.
Basic Qualifications: We are looking for professionals with these
required skills to achieve our goals:
--- 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 bachelors 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
Preferred Qualifications: If you have the following
characteristics, it would be a plus:
--- Bachelor of Science or Bachelor of Arts degree in a scientific
--- Demonstrated experience in regulatory inspection
--- Ability to work on multiple projects on a tight timeline.
--- Ability to prioritize and the flexibility to adapt to changing
--- Working knowledge of cGMPs and associated regulatory
requirements for the manufacture, testing, and release of
pharmaceutical/biopharmaceutical products for international
--- SAP knowledge
--- Experience working successfully both independently and in a
--- 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
--- Root cause analysis experience preferred.
--- Vaccines experience a plus.
Please apply today!
Keywords: Experis, Cambridge , QA Specialist 3rd Shift, Other , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!