What Does a Quality Assurance Specialist Do?
Quality assurance specialists ensure that products and services produced by an organization meet the desired quality standards. Their responsibilities include developing and implementing quality control procedures, monitoring product performance, and identifying and addressing quality issues. They also conduct audits and inspections to ensure compliance with quality standards and regulations.
It is common for quality assurance specialists to work in manufacturing or production facilities or in offices. They may collaborate closely with other departments and teams to gather and analyze product quality data. It is critical for professionals in this role to have strong analytical skills, attention to detail, and communication skills. In order to identify and communicate quality issues within an organization, specialists need these capabilities.
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National Average Salary
Quality assurance specialist salaries vary by experience, industry, organization size, and geography. To explore salary ranges by local market, please visit our sister site zengig.com.
The average U.S. salary for a Quality Assurance Specialist is:
Quality Assurance Specialist Job Descriptions
Crafting the perfect job description may be the key to finding an exceptional quality assurance specialist. To help you with your recruiting search, our team has put together some examples from past openings.
[Your Company Name] is seeking an amazing quality assurance specialist who loves people as much as they love spreadsheets! You’ll be deeply involved in a collaborative team environment, helping to supply our other positions with support by checking their work for accuracy to maximize their production potential. If you have a positive attitude, creative spirit, and enjoy serving others, this will be one of the most fulfilling jobs you’ve ever had! An ideal candidate is detail-oriented and has proven experience developing and implementing quality assurance procedures, conducting tests and inspections, identifying issues, and presenting reliable solutions.
Typical duties and responsibilities
- Developing and implementing quality assurance policies and procedures
- Performing routine inspections and quality tests
- Identifying and resolving workflow and production issues
- Ensuring that standards and safety regulations are observed
- Discussing issues and proposed solutions with superiors
- Documenting quality assurance activities and creating audit reports
- Creating training materials and operating manuals
- Complying with the company’s quality assurance standards
Education and experience
- High school diploma/GED required
- Bachelor’s degree preferred
- Previous experience in quality assurance or a similar field
Required skills and qualifications
- Strong analytical skills
- Excellent problem-solving and decision-making skills
- Outstanding verbal and written communication skills
- Knowledge of quality assurance terminology, methods, and tools
- Experience implementing corrective action
- Experience with data analysis tools and statistical analysis
- Works well with a team
The Quality Assurance Specialist is responsible for managing and documenting events/discrepancies associated with either product or process as well as managing/writing any investigations that may be a result of those event. This position interacts directly with manufacturing personnel and is responsible for maintaining a high-quality environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. Furthermore, this position will participate in the internal audit program and may assist with Supplier Audits/Certification programs, as well as customer audits.
If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you! Are you ready to improve people’s lives every day?
- Collaborates with management and supervisory personnel from Operations, Quality Control, and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and following up with Operations for non-conformance issues and a working jointly towards resolution
- Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead investigations of non-compliant issues according to procedures as defined by SOPs
- May author other types of quality system documents as directed or assigned by QA management
- Liaise with customers to ensure customer requirements are satisfied
- Facilitate ABC Company commitments and Effectiveness Checks, including initiation, tracking, trending, and closure
- Effective communication with Quality Assurance Manager regarding status of daily work
- Other duties as assigned
- Bachelor’s Degree in Science or related field required (Chemistry, Microbiology, or Biology)
- A minimum of 3-5 years related experience in QA pharmaceutical manufacturing
- Prior experience working with investigation writing, including root cause analysis and report writing a must (prior experience with preparing annual product reviews preferred)
- Strong organizational, analytical, and investigative skills, including ability to solve problems with minimal guidance, a must.
- Working knowledge of cGMPs and/or OSHA regulations required
- Motivated, self-started, team player
ABC Company is currently looking for an experienced Quality Assurance Specialist in (City, State) to work for a leading pharmaceutical manufacturer. The Quality Assurance Specialist will play a significant role in the oversight and regulatory compliance of cell therapy manufacturing.
Responsibilities for the quality assurance specialist include:
- Review clinical/commercial electronic batch records and documentation for completeness and accuracy in preparation for batch release
- Correct and revise documentation as needed
- Advise manufacturing personnel on proper documentation
- Utilize knowledge of FDA and GMP regulations to ensure compliance
- Assist in Deviation/OOS investigations
Qualifications for the quality assurance specialist include:
- A minimum of 1-5 years experience within Pharmaceutical Manufacturing
- Hands on experience with Batch Record review
- Proficiency in Microsoft Office
- B.S. in business or scientific field preferred
The Specialist – Quality Assurance (Customer Care) is responsible for acting as a liaison between ABC Company and other parties, processing product-related complaints, and tracking open cases in the Customer Relations Management (CRM) system. Additionally, the Customer Service Specialist supports the Quality Assurance team with the development and improvement of all customer service procedures, customer service statistics, and maintenance of master data in the CRM system. ABC Company is looking for someone who is recently wanting to grow their career in quality assurance including recent college graduates.
What you’ll do
- Process incoming product related customer issues for Food, Nonfood, Fruit & Veg, and online, including regular reporting, customer feedback, and compensation
- Independently request documents and information from suppliers in order to create department-specific documentation
- Create and monitor deadlines of internal and external communications such as service providers, stakeholders, business partners, and customers
- Compile customer service statistics
- Serve as point of contact for internal and external stakeholders in the case of current questions in relation to quality assurance
- Recognize criteria for escalation
- Conduct data entry and data management
- Perform research and investigate to support QA tasks
- Complete and review reports, cases, and tests, communicating results clearly to the relevant internal and external parties
- Perform other duties as assigned
What you’ll need
- Bachelor’s Degree; or High school diploma/GED and 4+ years of experience in related field
- Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)
- Excellent writing and communication skills
- Excellent organizational, analytical, and problem-solving skills
- Ability to work in a fast-paced working environment, including the store(s), distribution center(s), warehouse(s), and/or corporate office(s) with the capability to switch job functions/roles quickly
- This position commutes between stores, regional offices and/or distribution centers less than 25% of the time
- Preferred professional customer service experience, including work with CRM systems, ICIX, or Salesforce
Candidate Certifications to Look For
- Six Sigma Certifications – Six Sigma is a methodology used to improve processes and performance in a wide range of industries. The certification program consists of solving problems by proving they exist, identifying the root cause, and fixing the problems so they stay fixed. Six Sigma certified professionals are able to utilize statistical analysis to increase efficiency and reduce waste. The Six Sigma certification is made up of six levels (white belt through black belt) that progressively signify the level of skill, experience, and knowledge of the Six Sigma principles a quality assurance professional has. There are no eligibility requirements for any of these certifications, except for the black belt level.
- Certified Quality Engineer (CQE) – The CQE certification program is accredited by the National Commission for Certifying Agencies (NCCA) and proves candidates have the knowledge and ability required to use statistical analysis when diagnosing and fixing poor quality control practices. They have the skills to develop, analyze, and apply testing procedures, and operate quality control systems. The program familiarizes students with quality cost concepts and techniques, and provides them with the knowledge and ability to develop and administer management information systems. To earn this credential, candidates must have at least 8 years of on-the-job experience, with 3 of those years in a decision-making position.
- Certified Quality Auditor (CQA) – The CQA certification, also administered by the NCCA, demonstrates that a quality assurance professional understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine a quality system’s adequacy and deficiencies. Certified CQAs are qualified to evaluate a quality system and determine whether it adheres to the required criteria. Candidates must have worked in a full-time, paid role for 8+ years in the quality auditing field, and 3 years must be in a position where the candidate defined, executed, or controlled processes and was responsible for the outcome.
How to Hire a Quality Assurance Specialist
When hiring a quality assurance specialist, first consider the following:
- Recruiting: Do you have the knowledge, tools, and resources to attract and screen candidates?
- Complexity: Do you need a senior professional, or will mid or junior-level skills and experience suffice?
- Duration: Is this a one-time project or an ongoing need?
- Management: Do you have the time and expertise to direct the work effectively?
- Urgency: How soon does the work need to be completed?
- Headcount: Do you have the budget and approval for an internal employee, or should you consider alternate options?
Answering these questions will help determine the best course of action for your current hiring need. Fortunately, great options exist for every scenario. These are our recommendations:
1. Use 4 Corner Resources (or another professional recruiting firm)
The heavy lifting is done for you when working with a top-tier staffing company like 4 Corner Resources. We source, screen, recruit, and deliver only the most qualified candidate(s), saving you significant time and effort throughout the hiring process while you remain focused on your core business. Understanding your needs and ensuring the right candidate for the position is the key to our success.
This is the best route to take when:
- You need to fill the position quickly
- You want access to a vast talent pool of high-quality, prescreened candidates
- Your position is suited for temporary hiring services, contract staffing, or contract-to-hire recruiting, and you intend to direct the work activity.
- You are hiring an employee as a direct placement but aren’t able to recruit effectively or efficiently with your internal staff.
- You aren’t familiar with current salary rates, market trends, and available skill sets
2. Hire an experienced freelancer
The freelance, or gig, economy continues to grow, with more talent available daily. Freelancers provide high-quality work without a long-term commitment. They can offer you a fresh perspective, more flexibility, and increase efficiency. While the freelance market isn’t ideal for every position, quality assurance specialists are often a great fit.
We recommend this option when:
- Your need is project-based
- The work can be performed remotely
- You do not intend to direct the daily work activity
- You are hiring for expertise your internal team does not possess
- You do not require an employee to work onsite or follow a specific schedule
We recommend using either Toptal, Upwork, or both.
Toptal is an exclusive network of the top freelance software developers, designers, finance experts, product managers, and project managers in the world. Toptal vets its freelancers before making them accessible, ensuring their legitimacy. Top companies hire Toptal freelancers for their most important projects. Hiring a quality assurance specialist on Toptal can help you quickly get the results you need.
Upwork is a freelance talent network that helps individuals connect with experts in a variety of fields to accomplish project-based needs. When you have a specific, well-defined goal in mind, this can be a great path to hiring an experienced quality assurance specialist. If you are satisfied with the outcome you can continue to book the same freelancer through Upwork’s easy-to-use project interface.
3. Advertise your opening on a top job board
Your best option may be to advertise your opening on a proven job board. There are many widely used job sites out there that draw visits from qualified candidates. If you have someone internally who can dedicate the time and energy to sort through applications and screen individuals effectively, this can be a great choice.
We recommend using a job board when:
- Your internal recruiting team has the knowledge and experience to assess candidate qualifications
- You are hiring a direct employee and have time to manage the entire recruiting effort
- You have a process for receiving, screening, and tracking all resumes and applications
- You are prepared to respond to all applicants
We recommend CareerBuilder for quality assurance specialist openings:
CareerBuilder has been a trusted source for hiring since 1995. Reach 80+ million unique, diverse U.S. job seekers annually by posting your jobs through their talent acquisition channels. Through CareerBuilder, you can engage candidates and drive them into your sourcing pipeline. We recommend using CareerBuilder for hiring when you have the internal resources and processes to review, screen, and reply to all applicants.
4. Leverage your internal resources
You can utilize your own website, social media, and employees to assist in your search for top candidates.
A company website posting should be the first step in notifying prospective candidates that you are hiring. Social media can also be a powerful tool for spreading the word about your new opening. As far as exposure is concerned, this option can be as good as some job boards when you have a large enough following across various platforms, like LinkedIn, Instagram, Facebook, TikTok, and Twitter.
Current employees are every organization’s greatest asset. Encourage your internal team to promote job openings to their network by offering cash and other incentives.
We recommend these options when:
- Your brand has great name recognition
- You can consistently monitor and respond to candidate activity through your website and social media accounts
- You have a process in place to quickly and broadly communicate job openings and requirements
- You have an effective employee referral program in place
If you aren’t sure which path is best, schedule a discovery call today with our seasoned recruiting professionals. The 4 Corner team is on standby to help you find the best option for your unique hiring need.
Sample Interview Questions
- Could you tell me about your quality control procedures and how you ensure products are of high quality?
- When you’re dealing with multiple projects and deadlines, how do you prioritize your workload and manage it?
- What steps do you take to ensure that established quality regulations and standards are met, and how do you keep abreast of changes to these regulations?
- How do you handle conflict or pushback when identifying quality concerns that may affect a project’s timeline or budget?
- How do you decide on a device strategy?
- What charts and graphs do you use to report testing progress?
- Could you walk me through a process or project you managed from start to finish, emphasizing the role quality assurance played?
- How do you ensure quality assurance is integrated throughout the product development lifecycle?
- Do you have experience training quality assurance professionals?
- Are you familiar with writing quality assurance documentation?
- What methods do you use to collect and analyze product quality data, and how do you share your findings with internal stakeholders?
- What is your approach to making a difficult quality-related decision?
- To ensure that all team members are aware of and follow quality procedures, what methods do you use?
- What metrics do you use to measure success in continuous improvement initiatives related to product quality?