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QA Specialist 2nd Shift

Company: Experis
Location: Cambridge
Posted on: November 19, 2023

Job Description:

QA Senior Specialist
Cambridge, MA
Monday through Friday- Onsite- 2nd -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.

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
--- 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.

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 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.

Please apply today!

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

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About ManpowerGroup, Parent Company of: - -Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup - (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - -Manpower, Experis, Talent Solutions, and Jefferson Wells -- creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

Keywords: Experis, Cambridge , QA Specialist 2nd Shift, Other , Cambridge, Massachusetts

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