Job Listing Description

Quality Specialist II

Description:
Chipton-Ross is seeking a Quality Specialist II for an opening in Cambridge, MA.

SUMMARY:
The Quality Assurance Specialist II will support the quality systems team in Cambridge, MA. The Specialist will be responsible for evaluating, reviewing, and approving CAPAs or Change Controls. In this role, they will support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems.

RESPONSIBILITIES:
Conduct QA assessments of product specific change controls, quality issues, CAPA, GMP documentation and contributing to multiple project teams as the quality decision maker. Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations. Work with functional groups across the site to review and approve quality and technical documentation including: CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation. Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities. May perform archiving duties in support of QA Document Control. Will perform data migration from paper systems to new electronic data systems.

REQUIREMENTS:
Preferred experience working in 2 or more functional areas. Minimum of 2 years in cGMP Quality Control operations in a fast-paced production environment. Demonstrated ability collaborate across the business. Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process. Demonstrated ability to present ideas persuasively and negotiate effectively. Excellent written and oral communication skills both internal and external.

EDUCATION:
Accredited Bachelor's degree and 3 years of related work experience or Masterís degree and 1 year of work experience.

WORK HOURS:
Full-Time

 
Job Number: 188588
Job Location: Cambridge, MA
Rate: Up to $104.98 DOE
Duration: 3 mos
Input Date: 12/16/2020
Last Updated: 01/16/2021
Firm Name: CHIPTON ROSS
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808
Email: tharrell@chiptonross.com
Website: www.chiptonross.com

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