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Become A Quality Assurance Specialist

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Working As A Quality Assurance Specialist

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

  • Mostly Sitting

  • Repetitive

  • $77,100

    Average Salary

What Does A Quality Assurance Specialist Do At Astrazeneca Pharmaceuticals LP

* Develop and implement Quality Assurance processes and systems.
* Act as custodian for various Quality Assurance processes (Change Control, Calibration, etc.) as assigned.
* Write, edit, and review Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.
* Conduct Quality Event investigations (Nonconformance / failure, deviation, CAPA, etc.) and document in appropriate reporting methods and systems.
* Participate in internal Quality System / cGMP audits.
* Review batch documentation for correctness and completeness, and to release product for further processing or commercial trade.
* Review, prepare and perform qualification and periodic review activities for laboratory instruments/equipment
* Review the design and implementation of instruments/equipment to assure that security and data integrity are maintained
* Other duties as assigned

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

* Support Quality Assurance Manager with reviewing complaints for potential safety/non-safety issues and determination of regulatory Medical Device Reporting (MDR).
* Prepare and file Medical Device Reports (MDRs) with FDA and/or equivalent European regulatory agency.
* Analyze and prepare periodic trend analysis which are presented during management reviews and Global Sourcing Corporate Brand Trend Analysis to track and take appropriate corrective and preventative action to ensure patient safety and compliance with regulatory reporting requirements.
* Assist during FDA, ISO 13485 or other third party inspections involving complaint handling assessments or post market vigilance activities and product recall effectiveness checks.
* Conduct and coordinate appropriate adverse awareness training to Customer Service, Sales Teams, Field Satisfaction Teams and Distribution Centers.
* Develop, implement and update policies and procedures to ensure ongoing compliance with complaint handling and product recall requirements.
* Additional responsibilities may include:
* Assist with preparing, documenting and conducting Quality Assurance Audits of Distribution Centers, joint Ventures, X
* Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.
* Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.
* Stay current with new or potential business opportunities, and prepare for all QA activities.
* Research applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with U
* S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements).
* Conduct annual analysis of type of audits conducted and type of observations.
* Approve packaging/labels for all private label products to assure compliance with regulatory requirements
* Provide support to Corporate Brand Development Group, answering questions pertaining to regulatory issues with outsourced products and communicate to regulatory bodies as required.
* Participate in special projects and perform other duties as required.
* Intermediate level professional role.
* Some evaluation, originality or ingenuity required to perform tasks.
* Know and apply the fundamental concepts, practices, and procedures of a particular field.
* Apply company policies and procedures to resolve a variety of issues.
* Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
* Exercise judgment within defined procedures and practice to determine appropriate action.
* Build productive internal/external working relationships.
* Normally receive little instruction on day to day work, detailed instruction on new projects or assignments.
* Typically 2 to 4 years of related professional experience.
* Bachelor's Degree or global equivalent in Pharmaceutical Sciences, Chemistry or related discipline.
* Professional skills with an understanding of industry practices and company policies and procedures.
* Developing proficiency with tools, systems, and procedures.
* Good planning/ organizational skills and techniques.
* Developing problem solving skills.
* Good writing and communication skills.
* Typically hold 1 or more industry certifications (ASQ, RAPS, ISO or equivalent).
* Excellent conflict resolution skills.
* Good decision making skills.
* Excellent interpersonal skills.
* Exercise judgment within defined procedures and practices to determine appropriate action.
* Direction from manager/director is needed on some issues.
* General knowledge of ISO 9001 and 13485 certification and maintenance.
* Less than 30% travel to and from suppliers and/or HSI facilities
* Office environment

What Does A Quality Assurance Specialist Do At Aecom

* Ensures that quality software is provided for release to production by independently executing test scripts.
* Create, modify, and run test plans/cases to certify system functionality and/or changes.
* Review requirements, specifications and documentation to gain a thorough understanding of the programs and processes to be certified.
* Distribute test results to development staff to satisfy adequate unit testing.
* Maintain test databases and ensure their integrity and currency.
* Provide or validate estimates for assigned tasks

What Does A Quality Assurance Specialist Do At Community Health Systems

* Other duties may be assigned)
* Provide support for any quality initiatives (related to revenue related work product) within the Shared Services Center (SSC).
* Review work product from various SSC departments for accuracy and appropriate processing (best practices).
* Identifies performance improvement opportunities based on needs identified through data audits.
* Gathers business requirements for training development via identification of trends during the quality verification process.
* Provides data interpretation and act as a SME (subject matter expert) for the training team as needed.
* Provide class room support to the training team as needed.
* Assist with maintenance of QA work instructions and processes related to training for the various revenue cycle positions within SSC

What Does A Quality Assurance Specialist Do At Pfizer

* Provide Quality oversight to manufacturing operations
* Support Incoming material inspection and release
* Supplier Quality Oversight
* Support robust investigation into manufacturing deviations and facilitates timely identification of root cause and closure of the deviation.
* Perform lot release activities such as batch record review.
* Independently writes and/or reviews SOPs, technical reports, project plans, etc.
* Demonstrates complete knowledge of quality and manufacturing operations including both technical and compliance aspects.
* Demonstrates understanding of current aseptic manufacturing best practices.
* Supports implementation of quality assurance continuous improvement initiatives.
* May also present/defend QA Quality Systems during audits/inspections.
* This role may also require weekend work and some movement between shifts to support manufacturing operations as required

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Quality Assurance Specialist jobs

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Quality Assurance Specialist Career Paths

Quality Assurance Specialist
Quality Assurance Lead Senior Consultant Information Technology Manager
Chief Information Officer
11 Yearsyrs
Quality Assurance Supervisor Operations Manager Human Resources Manager
Director Of Human Resources
10 Yearsyrs
Quality Engineer Project Manager Information Technology Project Manager
Director Of Information
10 Yearsyrs
Quality Assurance Manager Quality Manager
Director Of Quality
14 Yearsyrs
Quality Manager Operations Manager Program Manager
Engineering Director
13 Yearsyrs
Project Manager Construction Manager Operations Manager
Operations Director
9 Yearsyrs
Quality Assurance Engineer Quality Assurance Manager
Operations Manager
7 Yearsyrs
Quality Engineer Senior Quality Engineer Quality Manager
Plant Manager
11 Yearsyrs
Business Analyst Product Manager General Manager
President Of Operations
11 Yearsyrs
Quality Assurance Quality Assurance Manager Project Manager
Program Manager
8 Yearsyrs
Quality Assurance Supervisor Quality Manager Operations Manager
Purchasing Manager
9 Yearsyrs
Senior Quality Assurance Analyst Senior Quality Assurance Engineer Quality Assurance Manager
Quality Assurance Director
11 Yearsyrs
Quality Assurance Quality Assurance Lead
Quality Assurance Manager
9 Yearsyrs
Quality Assurance Engineer Quality Assurance Lead Quality Assurance Manager
Quality Manager
11 Yearsyrs
Senior Quality Assurance Analyst Quality Assurance Team Leader Quality Assurance Manager
Quality Systems Manager
12 Yearsyrs
Project Manager Program Manager
Senior Manager
10 Yearsyrs
Quality Assurance Manager Project Manager
Senior Project Manager
12 Yearsyrs
Quality Assurance Lead Quality Assurance Team Leader Quality Assurance Manager
Senior Quality Assurance Manager
11 Yearsyrs
Business Analyst Information Technology Manager Director Of Information
Vice President Of Information Technology
12 Yearsyrs
Quality Manager Director Of Quality
Vice-President Of Quality
15 Yearsyrs
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Quality Assurance Specialist Demographics

Gender

  • Female

    56.0%
  • Male

    41.5%
  • Unknown

    2.5%

Ethnicity

  • White

    75.2%
  • Hispanic or Latino

    12.8%
  • Asian

    9.0%
  • Unknown

    2.2%
  • Black or African American

    0.7%
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Languages Spoken

  • Spanish

    63.2%
  • French

    7.3%
  • Russian

    3.2%
  • Chinese

    3.1%
  • German

    3.1%
  • Portuguese

    2.8%
  • Mandarin

    2.6%
  • Japanese

    2.5%
  • Italian

    2.2%
  • Hindi

    1.5%
  • Korean

    1.5%
  • Arabic

    1.4%
  • Cantonese

    1.1%
  • Tagalog

    0.9%
  • Carrier

    0.8%
  • Urdu

    0.8%
  • Croatian

    0.6%
  • Hebrew

    0.5%
  • Vietnamese

    0.5%
  • Gujarati

    0.5%
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Quality Assurance Specialist

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Real Quality Assurance Specialist Salaries

Job Title Company Location Start Date Salary
Lead QA Specialist Insurance Services Office, Inc. Jersey City, NJ Aug 22, 2016 $132,500 -
$150,000
SQA Specialist Us Data Management, LLC New Providence, NJ Jan 05, 2016 $125,000
SQA Specialist Us Data Management, LLC New Providence, NJ Jan 01, 2015 $125,000
Principal Quality Assurance Specialist Symantec Corporation Mountain View, CA May 11, 2015 $120,000
Quality Assurance Specialist Thomson Reuters Markets LLC New York, NY Sep 01, 2015 $120,000
Quality Assurance Specialist Thomson Reuters (Markets) LLC New York, NY Oct 15, 2015 $120,000
Principal Quality Assurance Specialist Symantec Corporation Mountain View, CA Jan 10, 2016 $114,255
Principal SQA Specialist Symantec Corporation Culver City, CA Aug 18, 2016 $112,000
Principal Quality Assurance Specialist Symantec Corporation Mountain View, CA Jan 10, 2016 $110,115
Principal Quality Assurance Specialist Symantec Corporation Mountain View, CA Oct 01, 2015 $110,114
Quality Assurance Functional Specialist Thomson Reuters Markets LLC New York, NY Aug 22, 2015 $108,150
Assistant Vice President; QA Specialist Bank of America Charlotte, NC Jan 02, 2016 $108,000
Quality Assurance Specialist Wes Pharma Inc. Westminster, MD Oct 20, 2016 $84,427
Quality Assurance Specialist World Education Services New York, NY Dec 27, 2016 $84,198
Quality Assurance Specialist IDL Solutions, Inc. Chantilly, VA Oct 01, 2015 $83,782 -
$125,950
Quality Assurance Specialist Autonomic Technologies, Inc. Redwood City, CA Aug 18, 2015 $83,333
Quality Assurance Specialist IDL Solutions, Inc. Chantilly, VA Jan 10, 2016 $83,304 -
$125,950
Qa/Safety Compliance Specialist Bexco Enterprises Inc. Pico Rivera, CA Nov 16, 2016 $83,283
Quality Documentation Assurance Specialist III .07) Advanced Clinical Holdings Inc. Lexington, MA Oct 09, 2016 $83,200
Quality Assurance Specialist Medical Science & Computing, LLC Bethesda, MD Feb 22, 2016 $83,100 -
$100,000
Quality Assurance Specialist Novel Laboratories, Inc. Somerset, NJ Apr 11, 2016 $71,573 -
$81,000
Quality Assurance Specialist Datawiz Corporation Lakewood, CO Oct 11, 2016 $71,400
Quality Assurance Specialist Charles River Laboratories Contract Manufacturing Pa, LLC Boothwyn, PA Sep 15, 2016 $71,400
Quality Assurance Specialist Charles River Laboratories, Inc. Boothwyn, PA Aug 12, 2016 $71,400
Quality Assurance Specialist Datawiz Corporation Lakewood, CO Oct 04, 2016 $71,400
QA Specialist-Enterprise Java CDI Corporation Pontiac, MI Oct 01, 2015 $71,021
AVP; QA Specialist Bank of America N.A. Charlotte, NC May 09, 2016 $71,000 -
$91,000
Quality Assurance Specialist/Medical Services Citywide Home Care Inc. Glendale, CA Sep 19, 2015 $70,290

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Top Skills for A Quality Assurance Specialist

ProceduresQualityAuditsCustomerServiceRegulatoryRequirementsDataEntrySafetyCorrectiveActionTestPlansFDAQualitySystemsCapaTestCasesLaboratoryISOBatchRecordReviewRawMaterialsGMPWebManagementSystemSQLServer

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Top Quality Assurance Specialist Skills

  1. Procedures
  2. Quality Audits
  3. Customer Service
You can check out examples of real life uses of top skills on resumes here:
  • Authored and delivered classroom training on updated departmental procedures.
  • Performed monthly and quarterly quality audits.
  • Maintained rapport with customer service to provide aid with special requests as needed.
  • Provide direction and lead the development and implementation of Quality Management Systems that meet, company, customer and regulatory requirements.
  • Conducted data entry and verification of employee training records into Training Management System.

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Quality Assurance Associate

About the Bachelor of Science in Quality Assurance

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