Quality Assurance SpecialistJob Description, Salary, Career Path, and Trends
A quality assurance specialist ensures that products adhere to the company’s quality standards. They are responsible for developing quality inspection procedures and implementing inspection activities that detect and resolve product defects. Quality assurance specialists must be detail-oriented, excellent problem solvers, and have solid statistical analysis skills. If you enjoy solving problems and are an expert at planning and organizing, a job in quality assurance could be the right path for you.
Quality assurance specialists work in a variety of industries, performing tests of products or services to ensure that they comply with standards before the products or services are made available to consumers. This goes beyond making sure that the product is safe for consumers. They test such things as performance, usability, and reliability.
Sample job description #1
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
Sample job description #2
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
Sample job description #3
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
Average salary and compensation
The average salary for a quality assurance specialist is $75,000 per year in the United States and $63,690 including a yearly bonus. Salaries vary depending on experience, education, and geographical location.
Los Angeles, California
New York City, New York
Sample interview questions
How relevant is manual testing in an automated world?
How would you bring down the defects count in a project?
How do you decide on a device strategy?
What charts and graphs do you use to report testing progress?
How would you prioritize multiple projects?
What would you do if you identified an error that your team had missed?
How many years of experience do you have in the field?
Do you have any Six Sigma or related certifications?
What kinds of quality assurance software are you familiar with?
Have you performed quality assurance audits?
Describe a critical issue you identified.
Do you have experience training quality assurance professionals?
Are you familiar with writing quality assurance documentation?
What specific steps have you taken to improve manufacturing processes?
How would you ensure your team abides by quality assurance procedures?
What’s the difference between functional and non-functional testing?
What is the difference between verification and validation?
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