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. Click below to explore salaries by local market.
The average national salary for a Position is:
$123,456
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.
Example 1
[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
Preferred qualifications
- Experience implementing corrective action
- Experience with data analysis tools and statistical analysis
- Works well with a team
Example 2
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?
The role
- 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
The candidate
- 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
Example 3
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
Example 4
Summary
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.