Quality Assurance Specialist Job Description template and pdf with duties [2024]

Job summary 1

The Quality Assurance Specialist is responsible for quality compliance monitoring which includes researching, analyzing, and reporting on recommendations for improvement to optimize service delivery. Identification of trends in compliance, agent performance, or with customer climate is a requirement for this role. The Quality Assurance Specialist will compile, summarize and communicate findings to the appropriate department(s) with the purpose of creating insightful, customer centric business practices. The Quality Assurance Specialist will be responsible for identifying fractured processes and/or procedures and escalating to the appropriate supporting team ensuring the establishment, preservation, improvement and restoration of customer loyalty within the Customer Care organization.

Duties & Responsibilities 1

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Perform Quality Assurance audits in accordance with Department policy to maintain service and customer satisfaction goals.
Demonstrate proficiency and full understanding of all the Company's products and services.
Creatively approach problems in new and different ways that lead to innovative solutions.
Must be able to accurately identify root cause for complex problems, recommend and apply appropriate interventions to avoid future occurrence.
Identify broken processes that negatively affect the customer experience and escalate as appropriate.
- Identify actions that violate policy or fail to protect the business, in accordance with trained or documented call handling policy/processes, and escalate for managerial consideration of status changes for active employees based on performance and/or behavior observed.
- Act as a conduit for continuous improvement by raising issues that are consistently observed with regards failure to comply with processes or technology deficits.
- Document Quality Audit observations within the QA solution to document findings.

Requirements & Skills 1

Minimum of five years Customer Service experience in large operational organizations.
Degree or experience in education and/or certification related to Quality of Service delivery (or equivalent work experience)
Demonstrated leadership skills necessary to act as a catalyst to effect change across cross-functional areas.
Excellent analytical and research skills.
Strong verbal, written, and listening communications skills.
- Ability to plan for and engage in Change Management activities.
- Ability to work well under pressure while performing multiple tasks in a fast-paced environment.
- Familiarity with MS suite (Excel, Word, Access, and PowerPoint) programs and systems.

Job summary 2

We are seeking a Quality Assurance Specialist. Duties may include oversight of various aspects of change control and documentation, including but not limited to change control administration, records management, document control, local change control, and corporate change control. As a member of the Quality unit the Quality Assurance Specialist is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper GMP control of validated systems.

Duties & Responsibilities 2

Administers the local change control system, records management system, and/or documentation system.
Evaluate process/procedure changes as necessary. Drive continuous improvement of departmental processes.
Responsible for reviewing and approving Validation documents.
Come to agreement by managing communications through discussions and compromise.
- Investigate exceptions related to the documentation center or various change control processes to determine root cause and appropriate corrective action(s).
- Write or assist with the writing of Standard Operating Procedures.
- Perform other related duties as assigned or required.

Requirements & Skills 2

High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment.
Must have thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
Must have good organizational, presentation, project management, and meeting facilitation skills.
Bachelor’s Degree is required: Science, Documentation, or Engineering
3-5 years of Quality experience in a regulated environment (FDA regulated environment preferred).
Must be at least 18 years of age
- Typically requires travel less than 5% of the time.
- Office environment.
- Occasional lifting up to 25 lbs.

Job summary 3

The Quality Assurance Specialist position reports directly to the Director-Quality Compliance. The Quality Assurance Specialist is responsible for implementing and supporting the Quality Management System (QMS) in accordance with Company policies and procedures.

Duties & Responsibilities 3

Requirements & Skills 3

Bachelor Degree in Life Sciences or related field
3-5 years of GMP Quality experience in a pharmaceutical manufacturing environment
- Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems
- Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred
- Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant out comes

Job summary 4

As a key member of our Quality Assurance team, the Quality Assurance Specialist will work with our cross-functional partners such as Operations, Customer Care, and our Compliance teams in order to ensure our teams are providing a great overall customer experience!

Duties & Responsibilities 4

Evaluate and provide feedback on how Customer Care and Customer Operations teams interact with customers by monitoring, reviewing and scoring calls and emails
Coordinates and participates in calibration sessions with Customer Care and Customer Operations teams to ensure consistent application of quality standards
- Act as a subject matter expert to ensure all Customer Care and Customer Operations Team members are meeting our quality expectations and providing a great experience for all customers
- Collaborate with team members, recommend, develop, and implement process improvements based on collected data that can be used as benchmark measurements
- Gather exceptional calls and email correspondence to be added to our customer interaction library for training purposes

Requirements & Skills 4

You must have 2+ years of experience with working in a customer contact center environment with a focus on employee coaching and development
Previous experience working in a Quality Assurance role is a plus
Disciplined, self-motivated and reliable with ability to stay focused on a task and work independently
- Possesses a positive attitude with excellent interpersonal skills and the ability to interact and build strong working relationships with all levels of the organization
- Ability to work in a team environment and adapt to changing workload and circumstances effectively as well as respond to new information quickly
- Prior experience working in the financial services, fintech space or complex operational or customer support role a plus.

Job summary 5

Reporting to the Director of Quality Assurance and Monitoring, the Quality Assurance Specialist conducts clinical research auditing and quality improvement efforts for clinical trials.

Duties & Responsibilities 5

Provides educational and corrective action advice to faculty in preparation for FDA audits.
Serves as liaison between the investigator, the research team and the FDA during an actual inspection.
Records proceedings and summarizes inspection activity in real time.
- Consults to investigators needing data safety monitoring plan details/information for their grant application.
- Develops Data and Safety Monitoring Plans based on the risk assignment categories.
- Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

Requirements & Skills 5

Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience.
GCP training required within 3 months of hire.
Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information.
- Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule.
- Demonstrated knowledge of federal regulations governing human subject research and federal reporting requirements.
- Advanced interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.

Job summary 6

The Quality Assurance Specialist is responsible for assisting with the operation of the Quality Management System processes and associated programs as needed to achieve and maintain compliance with local, state, and federal regulations, including CDPH/CLIA/CAP, FDA/medical device regulations as well as supporting the necessary training associated with these regulations.

Duties & Responsibilities 6

Requirements & Skills 6

Job summary 7

The Quality Assurance Specialist will be responsible for coordination and support of Change Control activities. You will be responsible for establishing a foundation toward developing a world class Quality & Regulatory Team.

Duties & Responsibilities 7

Responsible for coordinating changes initiated by various functional groups, ensuring changes are complete, accurately documented and properly routed for review/approval per Standard Operating Procedure.
Supports Operations and Top Management with change management demonstrating awareness of changes that have business priority and the ability to communicate and coordinate these changes in a timely manner.
Collaborates with various functional groups, as necessary to ensure compliance according to the type of change.
Review Change Requests ensuring pre-requisites prior to routing.
Supports the change initiators with guidance on the requirements and best practices, as applicable to the Change Control Processes and documentation.
- Responsible for the management and documentation of a training program, as applicable to the users of the Change Control Processes.
- Responsible for the maintenance and continual improvement of Change Control Processes.
- Support the transition of Change Control Processes into Electronic System (e-QMS) and lead training events, as applicable to e-QMS users.

Requirements & Skills 7

Bachelor's degree and 4 or more years of experience in Quality Assurance / Regulatory Compliance is required.
- Experience facilitating group meetings, managing conflict, and assigning action items and meeting strict timelines.
- Knowledge of laws/regulations, standards, and guidance documents pertaining to the medical device industry (i.e., ISO 13485, ISO 14971, MDSAP, MDD/IVDD, MDR/IVDR, FDA Part 820 & 803).
- Strong computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages.

Job summary 8

The Quality Assurance Specialist is responsible for the support of Division to include internal and external database review, collection and dissemination of collected data, training and policy purchasing and implementation.

Duties & Responsibilities 8

Provide evaluation and supportive services to programs in the residential service division in the areas of compliance, training, policy and accreditation.
Provide oversight of division safety initiatives and workplace safety data.
- Work irregular days/hours, including nights, holidays and weekends, depending on needs
- Frequently transverse from one location to another.
- Meets all deadlines required by program supervisor and federal partners.

Requirements & Skills 8

4-year bachelor’s or undergraduate degree from an accredited
Preferred – 6 plus years related experience and/or training

Job summary 9

The Quality Assurance Specialist will be responsible for monitoring and measuring adherence to regulatory & operational requirements of all client documentation. Primary focus will comprise of the screening of all client-related records for review of compliance and adherence to the policies and procedures of the organization. Primary activities will support the Quality Improvement Department’s initiatives and requirements. This role is designed to ensure prevention of quality issues through continual monitoring of processes, procedures, and outcomes.

Duties & Responsibilities 9

Coordinate the preparation and ensure timely and successful submission of compliance reports
Work collaboratively with key staff regarding strategies in support of quality and compliance functions
Execute detailed quality assurance procedures including reviewing events, documents, records and reports for accuracy and effectiveness
Inspection and verification of documents to ensure quality requirements are met
- Prepare and present quality assurance review findings in an effective and concise manner
- Monitor quality assurance parameters and trends, collect statistics, and prepare monthly quality assurance reports
- Under direction of the Quality Improvement Director, identify and implement systemic quality improvement efforts

Requirements & Skills 9

Job summary 10

The Quality Assurance Specialist is responsible for supporting the Laboratory Services team and clinic laboratories and ensuring that laboratories are operating safely, efficiently and within all applicable state, federal and accrediting requirements.

Duties & Responsibilities 10

Reviewing urgent care clinic lab documentation
Training and mentoring of clinic staff
Providing guidance to clinic staff

Requirements & Skills 10

Education: Minimum of Bachelor of Science Degree in a lab-related field
Experience: Minimum of 1 year experience related in a clinical lab setting or equivalent Staff Training, Quality Assurance, Laboratory Training
Skills: Strong oral and written communication skills; knowledge Microsoft Office

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