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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

  • $90,686

    Average Salary

What Does A Senior Specialist Quality Assurance Do At Abbvie

* Independently reviews and approves master batch records, labels, specifications, and other manufacturing documents of drug products (DP) under clinical development in compliance with US FDA and international health agency requirements.
* Independently reviews and approves executed manufacturing batch records, analytical data, and associated documentation, including any deviations and investigation reports related to material disposition.
* Coordinates leads and conducts internal Quality Investigations as well as investigations at contract manufacturing organizations (CMOs).
* Performs person-in-plant (PIP) during manufacturing campaigns of DP at CMOs.
* Reviews and approves change control requests to ensure compliance with Company procedures, cGMP, and other applicable regulations.
* Represents QA and provides support to the internal CMC team.
* Lead compliance internal audits.
* Provides and prepares quality metrics as needed.
* Initiates updates and creation of new SOPs as required.
* Serves as Quality Representative for regulatory inspections as needed

What Does A Senior Specialist Quality Assurance Do At Gilead

* Leads quality review of
* validation activities for analytical operations, and contract labs across the
* clinical and commercial supply chains.
* Reviews and approves validation related laboratory exception events (e.g.
* investigations, deviations, CAPA), change control, test methods, and
* specifications; ability to coach and train cross-functional colleagues (AD and
* QC) to ensure cGMP compliance to these specific areas.
* Reviews, approves, and coordinates review of validation projects for small
* molecules and/or large biologics.
* Prepares and manages team schedule for this
* activity and tracks to ensure timelines are met.
* Proficient in and maintains awareness of laboratory controls per FDA and EU
* cGMP guidelines.
* Expertise in leading daily QA team activities including planned changes,
* deviations, investigations, and provides on-going support and training to more
* junior staff members in these areas.
* Reviews and approves AO validation efforts from phase 1 through commercial
* and highly experienced in method validation and method transfer guidelines per
* ICH and USP.
* Reviews and improves existing quality procedure workflows, identifies areas
* of improvement for efficiency and compliance, and leads implementation efforts
* in collaboration with cross-functional stakeholders.
* Serves as QA project lead, leads complex quality investigations/deviations,
* and independently authors or approves concise quality investigation reports
* with appropriate corrective action and preventive actions (CAPA).
* Acts as an Analytical QA subject matter expert in support of regulatory
* inspections and internal audits

What Does A Senior Specialist Quality Assurance Do At Exelon

* 1. Oversee the development and implementation of the Quality Assurance and Control group in alignment with the business initiatives set forth by the Distribution Contracting, the T&S/General Services Contracting, Locating/Landscaping groups, and the Vegetation Management group.
* Provide short and long term strategic initiatives designed to assure the highest levels of customer services to achieve Pepco Holdings / ComEd / PECO reliability and customer satisfaction goals.
* Assure quality assurance programs are in place, effective and value added.
* Assure observation and audits are completed, identify trends and issues and formulate strategic training and qualification plans
* Oversee the QA/QC group by developing and maintaining an environment that fosters a high performance culture and a learning organization.
* Assist QA/QC team in promoting diversity and inclusion and serves as the change agent for business initiatives and assures the human element is understood and considered.
* Assure timely recognition of employee contributions.
* Interface with other Pepco Holdings / ComEd / PECO departments and represent the company regarding contractor quality issues.
* Provide accurate and timely feedback regarding performance and operations.
* Conduct Performance Review Planning process.
* Facilitate open and honest communication with staff.
* Develop methods to assess communication effectiveness and implement continuous improvement initiatives.
* Position may be required to work extended hours, including 24 x 7 coverage during storms or other energy delivery emergencies

What Does A Senior Specialist Quality Assurance Do At Home Depot

* Keeps abreast of all innovations and changes to Home Depot systems to ensure having the appropriate tools and training to provide quality support.
* Provides agent training and coaching on processes to maximize agent efficiency and increase speed and accuracy of customer service.
* Provides customer support by answering agent questions and maintaining a presence at a help desk or other customer point of contact.
* May have financial responsibilities-budgeting and monitoring expenses.
* Lead operational projects-project estimation, monitor, control and reporting.
* Motivates assigned staff.
* Responsible for the development of less experienced associates; mentor and teach.
* MAJOR TASKS, RESPONSIBILITES AND KEY ACCOUNTABILITIES
* Regularly maintains, upgrades and supports existing systems to ensure operational stability for user groups.
* Identifies new and existing system requirements and installs the necessary hardware and equipment infrastructure (power, cables, etc.) to meet these requirements.
* Negotiates with vendors to ensure that all system requirements are met in a timely and efficient manner.
* Keeps abreast of all innovations and changes to Home Depot systems to ensure having the appropriate tools and training to provide quality support.
* Provides end-user training on systems to maximize operator efficiency and increase speed and accuracy of customer service.
* Provides customer support by answering end-user questions and maintaining a presence at a help desk or other customer point of contact.
* May have financial responsibilities-budgeting and monitoring expenses.
* Lead operational projects-project estimation, monitor, control and reporting.
* Selects, develops and motivates assigned staff.
* Responsible for the development of less experienced associates; mentor and teach.
* NATURE AND SCOPE
* Typically reports to a Manager, Assistant Manager, or Team Lead.
* May have supervisory responsibilities; may guide/lead newer associates and/or interns.
* Direct reports may include Associate Systems Specialist, Systems Specialist, Associate Operations Specialists, and/or Operations Specialists.
* Typically requires frequent persuasion or influencing of others.
* Usually assigns and reviews work of others.
* Typically procedures for analyzing situations and making conclusions are very diverse.
* Typically considers among many different options or procedures when solving problems.
* Typically, once given general assignments, determines priorities and defines what should be done and how to do it

What Does A Senior Specialist Quality Assurance Do At Leidos

* Establish and manage quality control standards to ensure professional, accurate, complete, and timely review and delivery
* Define, review, propose and develop process improvements for the SE Document Review and Preparation process
* Perform Data Quality analysis of deliverables and documents.
* Establish and maintain a process for evaluating system and software to include associated documentation
* Monitor the level of quality throughout the system and software life cycle.
* Conduct formal and informal reviews at pre-determined points throughout the development life

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Senior Specialist Quality Assurance Career Paths

Senior Specialist Quality Assurance
Quality Assurance Supervisor Quality Assurance Manager Production Manager
Continuous Improvement Manager
12 Yearsyrs
Quality Assurance Manager Quality Manager
Director Of Quality
14 Yearsyrs
Project Manager Senior Project Manager Engineering Director
Director Of Software Development
12 Yearsyrs
Manager, Software Quality Assurance Software Engineering Manager Project Engineering Manager
Engineering Program Manager
10 Yearsyrs
Quality Manager Operations Manager Business Analyst
Product Owner
9 Yearsyrs
Senior Quality Engineer Quality Control Manager
Project Quality Manager
10 Yearsyrs
Quality Assurance Manager Senior Quality Assurance Manager
Quality Assurance Director
12 Yearsyrs
Quality Assurance Director Manufacturing Director Quality Engineer
Quality Assurance Engineering Manager
8 Yearsyrs
Senior Quality Engineer Quality Assurance Lead Production Supervisor
Quality Control Supervisor
5 Yearsyrs
Consultant Lead Technician Quality Assurance Lead
Quality Lead
7 Yearsyrs
Quality Assurance Director Contractor/Consultant Quality Engineer
Quality Program Manager
11 Yearsyrs
Quality Assurance Team Leader Quality Assurance Supervisor
Quality Supervisor
7 Yearsyrs
Quality Assurance Lead Quality Assurance Manager
Quality Systems Manager
12 Yearsyrs
Quality Assurance Team Leader Senior Quality Assurance Analyst/Lead Quality Assurance Manager
Regulatory Affairs Manager
9 Yearsyrs
Project Manager Construction Manager Quality Control Manager
Research And Development Manager
7 Yearsyrs
Quality Assurance Lead Quality Assurance Supervisor Quality Manager
Senior Quality Manager
13 Yearsyrs
Quality Assurance Supervisor Quality Manager
Supplier Quality Manager
13 Yearsyrs
Manager, Software Quality Assurance Test Manager
Test Engineering Manager
9 Yearsyrs
Quality Manager Director Of Quality
Vice-President Of Quality
15 Yearsyrs
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Help others decide if this is a good career for them

Average Length of Employment
Quality Lead 3.1 years
Quality Specialist 3.0 years
Quality Assurance 2.3 years
Top Careers Before Senior Specialist Quality Assurance
Consultant 3.3%
Top Careers After Senior Specialist Quality Assurance
Consultant 4.3%
Manager 2.7%

Do you work as a Senior Specialist Quality Assurance?

Senior Specialist Quality Assurance Demographics

Gender

Male

48.7%

Female

48.6%

Unknown

2.7%
Ethnicity

White

54.7%

Hispanic or Latino

17.2%

Asian

12.4%

Black or African American

11.4%

Unknown

4.3%
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Foreign Languages Spoken

Spanish

65.9%

Russian

4.9%

German

4.9%

French

4.9%

Korean

4.9%

Chinese

2.4%

Turkish

2.4%

Urdu

2.4%

Carrier

2.4%

Mandarin

2.4%

Italian

2.4%
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Senior Specialist Quality Assurance Education

Schools

University of Phoenix

17.0%

University of Pittsburgh -

6.6%

University of Puerto Rico - Mayaguez

5.7%

George Mason University

5.7%

National University

4.7%

Strayer University

4.7%

Temple University

4.7%

Pennsylvania State University

4.7%

Purdue University

4.7%

University of Memphis

4.7%

Johns Hopkins University

4.7%

University of Massachusetts - Boston

3.8%

Fairleigh Dickinson University

3.8%

Webster University

3.8%

University of Alabama at Birmingham

3.8%

Kean University

3.8%

West Virginia University

3.8%

University of Houston

3.8%

University of South Florida

2.8%

Saint Louis University-

2.8%
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Majors

Business

27.1%

Biology

11.8%

Chemistry

9.2%

Computer Science

8.5%

Computer Information Systems

5.4%

Electrical Engineering

4.5%

Education

3.3%

Management

3.3%

Information Technology

3.1%

General Studies

2.8%

Psychology

2.4%

Accounting

2.4%

Management Information Systems

2.1%

Project Management

2.1%

Criminal Justice

2.1%

Health Care Administration

2.1%

Chemical Engineering

2.1%

Pharmacy

1.9%

English

1.9%

Finance

1.9%
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Degrees

Bachelors

45.2%

Masters

24.2%

Other

15.8%

Associate

7.1%

Certificate

4.2%

Doctorate

2.0%

Diploma

1.2%

License

0.3%
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Senior Specialist Quality Assurance Videos

Quality Assurance Associate

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Real Senior Specialist Quality Assurance Salaries

Job Title Company Location Start Date Salary
Senior Quality Assurance Specialist Brunel Energy, Inc. Houston, TX Jun 27, 2010 $240,000
Senior Quality Assurance Specialist Brunel Energy, Inc. Houston, TX Sep 26, 2012 $240,000
Senior Quality Assurance Specialist Brunel Energy, Inc. Houston, TX Apr 14, 2013 $240,000
Senior Quality Assurance Specialist Genentech, Inc. South San Francisco, CA Sep 15, 2012 $125,000
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
Senior Professional QA Dun and Bradstreet, Inc. Short Hills, NJ Mar 06, 2016 $118,450
Senior Professional QA Dun & Bradstreet, Inc. Short Hills, NJ Jun 03, 2013 $115,000
SR. Quality Assurance Specialist Symantec Corporation Mountain View, CA Oct 01, 2015 $103,587
Senior QA Professional Abbott Laboratories Lake Forest, IL Jul 18, 2016 $100,000
Senior Quality Assurance Specialist Swat Solutions, Inc. Saint Louis Park, MN Sep 09, 2015 $98,500
Senior Quality Assurance Product Specialist Charles River Systems, Inc. Burlington, MA Oct 01, 2012 $97,000 -
$115,000
QA Specialist, SR. II Valtech Solutions Inc. Ashburn, VA Dec 17, 2012 $95,313
SR. Specialist, Quality Assurance Avid Bioservices Inc. Tustin, CA Apr 13, 2015 $89,744
SR Quality Assurance and Validation Specialist Tropisys Information Systems, LLC Las Vegas, NV Aug 07, 2016 $89,086
Senior Quality Assurance Specialist Glaxosmithkline LLC Conshohocken, PA Mar 03, 2014 $89,000 -
$148,300
Senior Quality Assurance Specialist Bayer Healthcare LLC Berkeley, CA Oct 01, 2011 $87,000 -
$95,000
SR. Specialist-Qc/Qa Automation Test Engineer Synechron, Inc. Brentwood, TN Jun 16, 2016 $86,000
Quality Assurance Specialist Senior The PNC Financial Services Group, Inc. Strongsville, OH Mar 07, 2016 $85,359
Senior Specialist-Quality Assurance Systems In Motion, LLC Ann Arbor, MI Sep 05, 2012 $84,614 -
$95,000
Senior Quality Assurance Testing Specialist Adecco Group Na/Modis, Inc. Columbus, OH Mar 23, 2015 $83,543 -
$93,915
Senior QA Compliance Specialist Fresenius KABI USA Melrose Park, IL Nov 25, 2016 $76,710 -
$90,915
Senior QA Specialist UST Global Inc. Malvern, PA May 18, 2010 $74,000
SR. Quality Assurance and Validation Specialist Tropisys Information Systems LLC Cambridge, MA Dec 08, 2014 $73,986
Senior Quality Assurance Specialist GGA Software Services LLC Cambridge, MA Oct 01, 2011 $73,500

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Top Skills for A Senior Specialist Quality Assurance

  1. Test Plans
  2. Compliance
  3. Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Designed, developed and reviewed technical specifications, configuration, test plans and test execution that were prepared by analyst.
  • Assured loan underwriting compliance through various reporting agencies and customer provided references.
  • Reviewed and developed information for processes and diagnosis based on training and knowledge of medical processes and procedures performed.
  • Aligned processes with Pfizer global policies and regulatory requirements.
  • Reviewed and evaluated corrective / preventive actions (CAPA) associated Third Party investigation of manufacturing deviations.

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Top 10 Best States for Senior Specialist Quality Assurances

  1. District of Columbia
  2. New Hampshire
  3. Maryland
  4. Virginia
  5. Connecticut
  6. California
  7. Colorado
  8. Delaware
  9. New Jersey
  10. North Carolina
  • (175 jobs)
  • (109 jobs)
  • (383 jobs)
  • (664 jobs)
  • (231 jobs)
  • (2,686 jobs)
  • (356 jobs)
  • (90 jobs)
  • (494 jobs)
  • (668 jobs)

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