Usa-compliance Specialist Ii (manufacturing/quality) 3rd Shift Job In Framingham, Massachusetts, Tal

Published 2022-09-22
Expires 2022-10-22
ID #1179548690
81899 US$
Usa-compliance Specialist Ii (manufacturing/quality) 3rd Shift Job In Framingham, Massachusetts, Tal
United States, Massachusetts, Framingham,
Published September 22, 2022

Job details:

Job type: Full time
Contract type: Contract
Salary type: Per annum
Occupation: Usa-compliance specialist ii (manufacturing/quality) 3rd shift

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Onsite Role

Nights 7pm - 7am - rotating nights, holidays and weekends

Core Responsibilities

The Senior Compliance Specialist is responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions to ensure continued compliance to CGMPs as well as being responsible for providing technical support serving as a Subject Matter Expert (SME) to the QA team.

Actively supports the QA Operations team by providing technical support

Completes Phenix/Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls

Ensure all safety requirements are being met

Performs batch record and logbook review

Performs review of column packing and qualification records

Review and approve CRs related to EBRs

Function as SME on challenges related to production requiring quality input

Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps

Issue action notices and conduct affiliated provisional release

Conduct log book audits against compliance requirements

Review CV related documentation against specification

Perform media / buffer and intermediate release

Perform release of Cell Banks for forward processing (as applicable)

Support cross-functional internal audit activities and conduct walkthrough inspections

Execute containment activities

Provide expertise during procedure/SOP revision process and function as DCR approver for department related SOPs and PRs

Maintain a high level of personal compliance to the required standards

Partner with manufacturing and support operations to ensure a culture of continuous compliance

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Contact employer

    81899 US$ / Per annum

    Employer's info

    Registered on October 7, 2017


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    Category info:

    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.

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