What Does a Quality Specialist Do?

Quality control senior scientists ensure that testing, materials, and laboratory equipment are up to standard. In the course of their career, they can expect to perform tests for the quality of manufacturing processes in order to ensure compliance with predetermined criteria, as well as ensuring that final products are safe for sale or distribution. This is a career that requires the skills of teamwork, communication, writing, and prioritization. Also, good attention to detail and some technical skills will be needed.

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Quality Specialist Responsibilities

Here are examples of responsibilities from real quality specialist resumes representing typical tasks they are likely to perform in their roles.

Manage CMOs that provide Endo with API, bulk, packaging services, and/or finish goods, including clinical material.
Manage PPAP sample dimensional verification activities.
Recommend changes to organizational committee structure to achieve higher level of accountability and oversight.
Manage document control including initiating and revising procedures, QA approval and implementation of documents.
Manage performance improvement and quality improvement projects design to assess and improve health outcomes for Medicaid members.
Manage hospital core measures abstraction, registry abstractions and review services to assist healthcare organizations in improving performance.
Ensure efficient process quality with the utilization of DMAIC.
Maintain activities and documentation in compliance with quality requirements (GDP).
Perform compliance review of control documents and execute audits of DMS document subsets.
Communicate with facility leadership teams and SQF practitioner to ensure implementation of SQF standards.
Provide support to internal and agency inspections including in person contact with regulatory agencies as SME.
Create or revise procedures as necessary to maintain compliance with 21 CFR 210 , 211, and 820.
Review of the equipment records and DMS information if applicable to approve out of service machines for use.
Develop and implement quality relate EMR reports.
Participate in customer/regulatory audit to perform GDP audit review.

Quality Specialist Job Description

Between the years 2018 and 2028, quality specialist jobs are expected to undergo a growth rate described as "faster than average" at 8%, according to the Bureau of Labor Statistics. So if the thought "should I become a quality specialist?" Has crossed your mind, maybe you should take the growth rate into account. In addition, the number of quality specialist opportunities that are projected to become available by 2028 is 23,800.

Quality specialists average about $31.36 an hour, which makes the quality specialist annual salary $65,230. Additionally, quality specialists are known to earn anywhere from $43,000 to $98,000 a year. This means that the top-earning quality specialists make $50,000 more than the lowest earning ones.

Once you've become a quality specialist, you may be curious about what other opportunities are out there. Careers aren't one size fits all. For that reason, we discovered some other jobs that you may find appealing. Some jobs you might find interesting include an auditor/quality, specialist-small business, quality assurance auditor, and quality engineer.

Learn More About Quality Specialist Job Descriptions

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12 Quality Specialist Resume Examples

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Randy Reynolds Quality Specialist Contact Information Richmond, VA (220) 555-1963 rreynolds@example.com Skills Jenkins Identify Areas Quality Standards Management System Product Release Activities Appropriate Corrective Action Product Releases FDA Communication Product Quality Employment History Quality Specialist 2019 - Present Capital One Richmond, VA Administer escalation process and vendor relationships, including subject matter expert input, while coaching on required workflow processes and procedures. Evaluate customer credit card transactions to ensure compliance with applicable regulations as well as business intent and customer experience. Initiated ISO certification for a division of Industrial Service. Monitored supplier performance and drove supplier corrective action. Coordinated significant changes to the call monitoring procedures to streamline the process. Quality Assurance Specialist 2014 - 2019 Capital One Richmond, VA Evaluate customer credit card transactions to ensure compliance with applicable regulations as well as business intent and customer experience. Administer escalation process and vendor relationships, including subject matter expert input, while coaching on required workflow processes and procedures. Automated web application using Selenium Web Driver and JUnit. Tested the ETL process for both before data validation and after data validation process. Quality Assurance Associate 2013 - 2014 Food Lion Richmond, VA Maintained newly established corporate quality standards for the store. Understand and adhere to Food Safety guidelines and procedures. Used Infinity System to track heights, weights, and test results of product. Used Maven, Selenium Grid to execute Selenium automation suites on different platform, browser combinations in parallel. Education Bachelor's Degree Business 2010 - 2013 Colorado Technical University Colorado Springs, CO


Grace Russell Quality Specialist Contact Info New York, NY (440) 555-3514 grussell@example.com Skills Quality StandardsClaims IssuesClaims SystemProceduresBank ProductsManagement SystemDocument ControlBilling ProceduresIDXCgmp Regulations Employment History Quality Specialist 2016 - Present Bank of America New York, NY Tasked to lead training organization of over 15 people in to train the company policies and leadership trainings. Trained new team members on applying due diligence in following procedures and regulatory time and customer service expectations. Billing Representative 2015 - 2016 Anthem Los Angeles, CA Coordinated special projects involving a conversion to a new computer system. Resubmitted claims with appropriate documentation to insurance companies. Contacted Insurance Companies and verified patient claim information for rebilling and payment. Make necessary arrangements for medical records request, completions of additional information requests, etc.. as requested by insurance companies. Registered patients as they entered the emergency room. Claims Analyst 2013 - 2015 Anthem Los Angeles, CA Follow up retention leads through outbound communication via phone or in writing. Process medicaid claims for members and providers Guaranteed accurate claims processing, correcting coding and / or updating information, as requested by provider or member. Received email and faxes of hard-copy claims and all types of medical records along with different types of documents. Review charge entry data to ensure correct claims filing, bill clean claims to commercial and managed care insurance companies. Education Bachelor's Degree Business 2005 - 2008 California State University - San Bernardino San Bernardino, CA


Charles Jordan Quality Specialist Morris Plains, NJ (720) 555-6362 cjordan@example.com Experience Quality Specialist2016 - Present Merck & Co.•Morris Plains, NJ Use SQL*LIMS System to manage data samples, results and approve results. Conducted quality review and approval of new and updated SOPs. Support Quality and Operations in department reviewing Electronic Batch Records and related reports. Chemist2013 - 2016 Pfizer•Morris Plains, NJ Worked in the central nervous system (CNS) chemistry division of drug discovery. Performed ERES assessment of Empower software for HPLC instrumentation. Provide LIMS training to new employees. Perform chemical and physical analysis on raw materials and bulk samples in compliance with USP and internal procedures. Quality Control Analyst2008 - 2013 Aerotek•Indianapolis, IN Performed Analytical testing using HPLC, GC. Performed Inspection on incoming per IPC-A-610 andJ-STD-001 Performed quality checks using calipers, micrometers, and depth gauges. Performed quality control test on raw materials, in processed and finished production batches using analytical instruments. Translate QA meetings and workers. Used various inspection equipment to include micrometers, verniers, optical comparator, thread mics etc. Skills HplcData IntegrityProduct DevelopmentAction PlansPpapQuality ImprovementProduct QualityProceduresLab EquipmentAppropriate Corrective Action Education Bachelor's Degree Health Care Administration2005 - 2008 Monroe College•Bronxville, NY

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Quality Specialist Skills and Personality Traits

We calculated that 8% of Quality Specialists are proficient in Customer Service, Data Analysis, and Continuous Improvement. They’re also known for soft skills such as Creativity, Listening skills, and Math skills.

We break down the percentage of Quality Specialists that have these skills listed on their resume here:

Customer Service, 8%
Accredited quality of life specialist that cared for seniors within a facility setting, provided outstanding customer service guaranteeing life excellence.
Data Analysis, 6%
Facilitated quality system management by ensuring product and process quality through internal audits, data collection, and data analysis.
Continuous Improvement, 6%
Lead a team to develop Supplier Quality/Delivery performance dashboards for quality evaluation and instituted supplier quality workshops for continuous improvement.
Process Improvement, 5%
Assist management in compliance and process improvement utilizing Six-Sigma, ISO and Continuous Process Improvement methodologies and consistent training and engagement.
Management System, 5%
Partnered with suppliers to establish and initiate an effective corrective action and root cause analysis program within their quality management system.
FDA, 5%
Reviewed and approved equipment calibrations, qualifications, and validations for adherence to company procedures and FDA guidelines.

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Most quality specialists list "customer service," "data analysis," and "continuous improvement" as skills on their resumes. We go into more details on the most important quality specialist responsibilities here:

Arguably the most important personality trait for a quality specialist to have happens to be creativity. An example from a resume said this about the skill, "industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal." Additionally, other resumes have pointed out that quality specialists can use creativity to "manage sample inventory worth $500,000+.product quality specialist"

Another trait important for fulfilling quality specialist duties is listening skills. According to a quality specialist resume, "these engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff." Here's an example of how quality specialists are able to utilize listening skills: "delegated to the call listening team where we ensured that calls were being graded appropriately to the standards set by cms. "

Another skill that is quite popular among quality specialists is math skills. This skill is very critical to fulfilling every day responsibilities as is shown in this example from a quality specialist resume: "industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work." This example from a resume shows how this skill is used: "created presentations on non-conforming statistics for managers monthly quality review meetings using access and microsoft word applications. "

A thorough review of lots of resumes revealed to us that "speaking skills" is important to completing quality specialist responsibilities. This resume example shows just one way quality specialists use this skill: "industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available" Here's an example of how this skill is used from a resume that represents typical quality specialist tasks: "experience speaking to auditors from fda, ema, mexico, and turkey. "

Yet another important skill that a quality specialist must demonstrate is "writing skills." Industrial engineers must prepare documentation for other engineers or scientists, or for future reference This is clearly demonstrated in this example from a quality specialist who stated: "report writing includes fda sample collection & results of quality analysis, microbiological, water & surimi testing. "

Another skill commonly found on quality specialist resumes is "problem-solving skills." This description of the skill was found on several quality specialist resumes: "in designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance." Here's an example from a resume of how this skill could fit into the day-to-day quality specialist responsibilities: "resolved regulatory and quality issues by collaborating with sales, logistics, operations and fda personnel. "

See the full list of quality specialist skills.

We've found that 55.5% of quality specialists have earned a bachelor's degree. Furthermore, 10.1% earned their master's degrees before becoming a quality specialist. While it's true that most quality specialists have a college degree, it's generally possible to become one with only a high school degree. In fact, one out of every seven quality specialists did not spend the extra money to attend college.

The quality specialists who went onto college to earn a more in-depth education generally studied business and biology, while a small population of quality specialists studied nursing and health care administration.

Once you're ready to become a quality specialist, you should explore the companies that typically hire quality specialists. According to quality specialist resumes that we searched through, quality specialists are hired the most by CSL Plasma, TPI, and Conagra Brands. Currently, CSL Plasma has 176 quality specialist job openings, while there are 66 at TPI and 52 at Conagra Brands.

Since salary is important to some quality specialists, it's good to note that they are figured to earn the highest salaries at Meta, Citi, and Biogen. If you were to take a closer look at Meta, you'd find that the average quality specialist salary is $127,007. Then at Citi, quality specialists receive an average salary of $117,736, while the salary at Biogen is $116,302.

View more details on quality specialist salaries across the United States.

We also looked into companies who hire quality specialists from the top 100 educational institutions in the U.S. The top three companies that hire the most from these institutions include Real Time Farms, Baxter International, and General Electric.

The three companies that hire the most prestigious quality specialists are:

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What Auditor/Qualitys Do

A quality auditor is responsible for inspecting the company's services and products, ensuring its adherence to business requirements and internal regulations. Quality auditors analyze the efficiency of operational functions and production processes to maintain high-quality deliverables with the utmost consideration for the safety and security of the production staff. They run quality checks for the outputs, create findings reports, and strategize methodologies to enhance stability by utilizing standard testing parameters. A quality auditor must have excellent communication and organizational skills, as they may also recommend opportunities to generate more resources and increase revenues.

In this section, we compare the average quality specialist annual salary with that of an auditor/quality. Typically, auditors/quality earn a $29,918 lower salary than quality specialists earn annually.

Even though quality specialists and auditors/quality have vast differences in their careers, a few of the skills required to do both jobs are similar. For example, both careers require customer service, continuous improvement, and process improvement in the day-to-day roles.

There are some key differences in responsibilities as well. For example, a quality specialist responsibilities require skills like "data analysis," "center management," "osha," and "patients." Meanwhile a typical auditor/quality has skills in areas such as "audit results," "calipers," "quality procedures," and "appeals." This difference in skills reveals how truly different these two careers really are.

Auditors/quality really shine in the retail industry with an average salary of $40,479. Whereas quality specialists tend to make the most money in the government industry with an average salary of $64,103.

The education levels that auditors/quality earn is a bit different than that of quality specialists. In particular, auditors/quality are 3.8% less likely to graduate with a Master's Degree than a quality specialist. Additionally, they're 0.1% less likely to earn a Doctoral Degree.

What Are The Duties Of a Specialist-Small Business?

A small business specialist develops new business programs to meet changing customer demands. They are responsible for ensuring integrity and consistency in the domain of business. They analyze causes of a business issue, obtain business data, and make enquiries. They are responsible for making purchase agreements, confidentiality arrangements, and joint venture arrangement.

The next role we're going to look at is the specialist-small business profession. Typically, this position earns a higher pay. In fact, they earn a $7,088 higher salary than quality specialists per year.

While some skills are similar in these professions, other skills aren't so similar. For example, several resumes showed us that quality specialist responsibilities requires skills like "data analysis," "continuous improvement," "process improvement," and "management system." But a specialist-small business might use skills, such as, "customer relationships," "business development," "business portfolio," and "business administration."

In general, specialist-small businesses study at similar levels of education than quality specialists. They're 2.2% less likely to obtain a Master's Degree while being 0.1% more likely to earn a Doctoral Degree.

How a Quality Assurance Auditor Compares

Quality assurance (QA) analysts are responsible for testing company products and processes. Through testing, QA analysts ensure that the product or process is ready for production. They check whether the process meets company standards and guidelines, as well as any standards related to the industry they are in. QA analysts are in charge of determining the root cause of any problems that they may encounter. They also try to solve these as soon as possible. They also ensure that the company's products meet user expectations as well as the company's brand promise.

The quality assurance auditor profession generally makes a higher amount of money when compared to the average salary of quality specialists. The difference in salaries is quality assurance auditors making $12,305 higher than quality specialists.

By looking over several quality specialists and quality assurance auditors resumes, we found that both roles utilize similar skills, such as "process improvement," "management system," and "fda." But beyond that the careers look very different.

There are many key differences between these two careers as shown by resumes from each profession. Some of those differences include the skills required to complete responsibilities within each role. As an example of this, a quality specialist is likely to be skilled in "customer service," "data analysis," "continuous improvement," and "center management," while a typical quality assurance auditor is skilled in "clinical trials," "quality assurance audits," "audit reports," and "glp."

Additionally, quality assurance auditors earn a higher salary in the pharmaceutical industry compared to other industries. In this industry, they receive an average salary of $87,841. Additionally, quality specialists earn an average salary of $64,103 in the government industry.

When it comes to education, quality assurance auditors tend to earn similar education levels than quality specialists. In fact, they're 1.2% less likely to earn a Master's Degree, and 0.6% less likely to graduate with a Doctoral Degree.

Description Of a Quality Engineer

A quality engineer's responsibilities include ensuring that the manufacturing processes are efficient and accurate, documenting findings that would raise concerns, conducting quality tests while observing parameters, and implementing changes as necessary to meet the highest quality standards. Quality engineers need to have excellent problem-solving and observation skills to detect any irregularities and possible malfunctions. They also must be able to communicate effectively with the clients for feedbacks and corrective adjustments, address complaints, and immediately resolve any inconsistencies made.

Quality engineers tend to earn a higher pay than quality specialists by about $14,442 per year.

While their salaries may vary, quality specialists and quality engineers both use similar skills to perform their jobs. Resumes from both professions include skills like "data analysis," "continuous improvement," and "process improvement. "

Even though a few skill sets overlap, there are some differences that are important to note. For one, a quality specialist might have more use for skills like "customer service," "center management," "osha," and "dexterity." Meanwhile, some quality engineers might include skills like "process control," "statistical analysis," "pfmea," and "gd" on their resume.

In general, quality engineers make a higher salary in the technology industry with an average of $84,890. The highest quality specialist annual salary stems from the government industry.

In general, quality engineers reach similar levels of education when compared to quality specialists resumes. Quality engineers are 2.6% more likely to earn their Master's Degree and 0.0% less likely to graduate with a Doctoral Degree.

What a Quality Specialist Does FAQs

What Are The Top 3 Skills For A Quality Assurance Specialist?

The top 3 skills for a quality assurance specialist are communication, time management, and attention to detail. As a quality assurance specialist, you will be working among a team to guarantee that the final product observes the company's quality standards.

What Makes A Good Quality Specialist?

Good quality specialists are able to leverage technology and analytical skills to spot bugs and errors in software quickly. A quality specialist is needed to spot bugs and errors in software early in the development phase.

Have more questions? See all answers to common business and financial questions.

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Updated October 2, 2020