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Become A Senior Specialist Quality Assurance

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Working As A Senior Specialist Quality Assurance

  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Getting Information
  • Processing Information
  • Documenting/Recording Information
  • Deal with People

  • Mostly Sitting

  • Repetitive

  • $99,930

    Average Salary

What Does A Senior Specialist Quality Assurance Do At Merck

* Provide QA support for the GxP computerized systems to ensure the maintenance of compliance of the IT GxP Quality Program.
* Perform critical review of computer system validations and equipment qualifications in reference to internal and external standards.
* Provide support for planning, coordination, performance and documentation of both internal and external audits in line with appropriate requirements.
* Administer and maintain QA related electronic systems (Sharepoint, EDMS, and training systems).
* Maintain an efficient document management system for controlled documents.
* Maintain documentation of QA tasks in compliance with associated requirements and internal SOPs.
* Provide support for global QA initiatives and keep current on IT QA trends globally.
* Communicate across R&D QA team and foster a productive and efficient team environment

What Does A Senior Specialist Quality Assurance Do At Henry Schein, Inc.

* _
* Typically responsible for two or more of the following duties:
* Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.
* Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of medical devices.
* Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk.
* Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products.
* Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.
* Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance.
* Provide support during government inspections and formulating the appropriate response and corrective actions.
* Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
* Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.
* Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follow-up on CAPAs/observations.
* Stay current with new or potential business opportunities and prepare for all QA Activities.
* Research applicable FDA, ISO standards to ensure the company’s ongoing compliance with the U
* S. and International Regulatory requirements (Medical Devices Directives and FDA QS Requirements).
* Approve packaging/labels for all private label products to assure compliance with regulatory requirements.
* Participate in special projects and perform other duties as required.
* TRAVEL

What Does A Senior Specialist Quality Assurance Do At Catalent Pharma Solutions

* Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.
* Maintains and enhances effectiveness of the Quality System, including identification and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Risk Management, and Deviation processes.
* Accountable for the execution of the Internal Audit program.
* Responsible for managing customer audits, including coordination of the audit with the customer and internal Catalent stakeholders, hosting audits and providing accurate information regarding the Quality Management Systems and Catalent operations, and oversight of the audit response and follow up actions required by Catalent.
* Conduct audits of suppliers and vendors to support the Supplier Quality Assurance program.
* Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
* Responsible for maintaining a sufficient understanding of the Quality Management Systems and operations to provide oversight and decision making as appropriate in the absence of the QA Systems Supervisor.
* Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.
* Provides technical assistance and training for personnel.
* Files and maintains controlled documents.
* Other duties as assigned.
* III

What Does A Senior Specialist Quality Assurance Do At Merck

* Supportthe development, implementation, and maintenance of critical processesvia systems support such as Deviation Management, Product Release, documentationcollaboration, metrics, Change Control, including managing associatedmaster data
* Provideongoing production / master data support ensuring EQA data and processesrun smoothly with no interruption to supply
* Functionindependently and exercise leadership to identify and implementimprovements to existing business processes and systems; establish newor improved processes, tools, and systems and drive consistent, standardbusiness processes across EQA
* Maintainand provide expertise on EQA systems, tools, data, and processes on anongoing basis, such as COMET SAP / RCT, Supplier Transparency, GCM,Orion, RCAM, Tracelink, etc.
* Serve as the systems / process SME forassigned processes when IT and Business Systems representation isneeded.
* Supportthe implementation of strategic projects (e.g., QSIP)
* Responsiblefor developing / maintaining / and delivery of training materials andjob aids
* Assistin the preparation and coordination of Senior Management presentations
* Assurecompliance with established policies/procedures of the Division andCorporation and complies with all applicable governmental regulations(GMP, etc.), both domestic and foreign.
* Operate in a safe and efficient manner and incompliance with the MMD QO Safety and Health Policy

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Senior Specialist Quality Assurance jobs

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Senior Specialist Quality Assurance Demographics

Gender

  • Female

    48.3%
  • Male

    46.9%
  • Unknown

    4.8%

Ethnicity

  • White

    75.1%
  • Asian

    11.5%
  • Hispanic or Latino

    10.9%
  • Unknown

    1.8%
  • Black or African American

    0.7%
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Languages Spoken

  • Spanish

    50.0%
  • German

    16.7%
  • Korean

    16.7%
  • Italian

    16.7%
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Senior Specialist Quality Assurance Education

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Real Senior Specialist Quality Assurance Salaries

Job Title Company Location Start Date Salary
SR. Specialist QA Amgen Inc. Thousand Oaks, CA Nov 07, 2011 $123,091
SR Specialist QA Amgen Inc. Thousand Oaks, CA Nov 07, 2011 $122,519
SR. Specialist-Technology/Sr. QA Analyst Synechron, Inc. Charlotte, NC Jan 07, 2016 $93,600
Senior Specialist-Quality Assurance Systems In Motion, LLC New York, NY Jan 23, 2013 $92,893 -
$95,000
SR. Specialist, Quality Assurance Avid Bioservices Inc. Tustin, CA Apr 13, 2015 $89,744
SR. Specialist-Qc/Qa Automation Test Engineer Synechron, Inc. Brentwood, TN Jun 16, 2016 $86,000
Senior Specialist-Quality Assurance Systems In Motion, LLC Ann Arbor, MI Sep 05, 2012 $84,614 -
$95,000
Senior Specialist R&D QA Actavis Elizabeth, LLC Elizabeth, NJ Jun 30, 2013 $77,418 -
$79,858

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Top Skills for A Senior Specialist Quality Assurance

EnsureComplianceProceduresCapaQualityAuditsRegulatoryComplianceFDABatchRecordReviewDrugProductContainersLaboratoryInvestigationsAnalyzeDataSafetyFacilityValidationProtocolsCFRInternalAuditsQualitySystemsISOCgmpComplianceQCIII

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Top Senior Specialist Quality Assurance Skills

  1. Ensure Compliance
  2. Procedures
  3. Capa
You can check out examples of real life uses of top skills on resumes here:
  • Conduct weekly, monthly, and quarterly audits to ensure compliance to Quality System (QS) regulations.
  • Assist Manufacturing, Process and Control Engineers in the monitoring of manufacturing procedures and defects analysis.
  • Provide feedback to Quality Assurance for investigations and CAPA s analysis.
  • Managed daily and monthly reports regarding quality audits.
  • Phase II Projects: Regulatory Compliance Development: Created, modified or enhanced the effectiveness of numerous Quality Programs.

Top Senior Specialist Quality Assurance Employers

Senior Specialist Quality Assurance Videos

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