QA Associate Job Description

QA Associate Job Description

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QA associate provides production floor support and guidance on any manufacturing related issues for GMP Continuous and non-continuous product manufacturing.

QA Associate Duties & Responsibilities

To write an effective QA associate job description, begin by listing detailed duties, responsibilities and expectations. We have included QA associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Enforcement of GMP Compliance
Reviews test scripts for functional and regression testing
Performs manual testing of interactive products focusing on functional and end-to-end testing, validating that system response and output accurately reflect business requirements as outlined in requirements document
Assists in selecting automated testing tool(s)
Conducts test planning for new feature development
Actively participates in reviews at all phases of the development cycle across a variety of mediums
Contributes to overall Quality Assurance best practices, strategy and methodology
Identifies gaps in all inputs into testing and suggests solutions to head of QA
Acts as a strong advocate for quality in the product development process for software engineering
Reviews production batch records and associated data for product release

QA Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for QA Associate

List any licenses or certifications required by the position: ASQ, ISTQB, ISO, ACAMS, CQA, CSQA, CSTE, GDP, ITIL, QP

Education for QA Associate

Typically a job would require a certain level of education.

Employers hiring for the QA associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Computer Science, Science, Engineering, Technical, Chemistry, Biology, Education, Life Sciences, Information Systems, Life Science

Skills for QA Associate

Desired skills for QA associate include:

US end European GMP regulations and guidance
SAP
US Drug Product GMP requirements and associated guidelines
Biotech bulk and finished product manufacturing
US and EU cGMP regulations and guidance
GMP
Analytical testing
Changes and issues
Inspection citations
LIMS

Desired experience for QA associate includes:

The QA Engineer will develop, maintain and execute automated scripts based on manual test cases
2-3 years of experience Quality Assurance
Demonstrated ability to read and comprehend written technical procedures revise SOPs as needed
SQL for Oracle, with ability to run in TOAD and/or SQL+
No prior QA experience necessary
Has experience working with relational databases

QA Associate Examples

1

QA Associate Job Description

Job Description Example
Our company is growing rapidly and is looking to fill the role of QA associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QA associate
  • Assure effective systems, and controls are established and maintained for all manufactured products in the Integrated Production Stream (IPS) environment
  • Establish a robust, aggressive system to assure corrective and preventative measures are systematically implemented, monitored, and controlled
  • Develop, track, and report on department metrics, and department objectives
  • Manage product quality complaint system and make recommendations to senior site management on the recall of product
  • Provide leadership to departmental personnel to include Integrated Production Stream (IPS) quality assurance technicians, the Quality Assurance direct reports
  • Communicate openly and often with cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning
  • Articulate Quality Systems vision/strategy to peers and subordinates and gain commitment influence behaviors to drive results
  • Foster and maintain relationships with key external vendors and/or associations
  • Effectively drive teamwork up, across and down, organization to deliver results
  • Contributes to impact assessments from Feature enhancements on system level interactions, and existing regression and automated test suites
Qualifications for QA associate
  • Assisting with the preparation of Internal Audit presentations for Audit Committees, Management Committees, Compensation Committee, Global and Regional Managers� Meetings, regulatory and stakeholder meetings
  • Involvement in group-wide methodology initiatives including risk assessment and annual planning, logging audit plan changes, reviewing continuous monitoring results and audit issue status reporting
  • Graduate or similar higher education qualification (1st or 2nd or equivalent class)
  • Proficiency in MSWord and/or Excel
  • Strong experience on programing, especially on java/python/javascript
  • Knowledge of Fill Finish and Biologics production environments strongly preferred
2

QA Associate Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of QA associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA associate
  • Ensure appropriate escalation of GMP/GDP related issues including critical complaints, potential counterfeits, potential recalls, critical product quality issues and Health Authority issues related to product compliance/quality in accordance with internal Novartis procedures
  • Assist with the testing of daily tickets addressed by development
  • Assist Senior QA Engineer staff with the creation of data sets to test measures (PQRS, QCDR, ECQM, etc)
  • Develop and maintain strong knowledge of our products and services with an emphasis on those developed in the Pittsburgh office for the purpose of being able to configure and test the technology based upon client's requirements
  • Be detailed oriented and able to follow direction
  • Ability to work under pressure, be flexible and able to adapt to a changing environment
  • Perform and review audits for departments as requested
  • Prepare audit findings in professional manner and prepare to discuss with management
  • Participates in creating test plans, test data, test cases, and test scripts
  • Participates in formal reviews of business requirements, user stories and application design
Qualifications for QA associate
  • Bachelor's degree in a technical discipline (engineering or biological sciences) or equivalent work experience
  • Proficiency with Trackwise® quality management software
  • Understanding and application of Risk Assessment tools (Hazard Analysis, Fault Tree Analysis, FMEA)
  • Bachelor's Degree in an engineering or science related field
  • Strong Engineering background preferred
  • Expierence with Trackwise and GMAR preferred
3

QA Associate Job Description

Job Description Example
Our company is looking to fill the role of QA associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA associate
  • Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor
  • Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, , including active participation in investigation, evaluation, and problem resolution
  • Consult with programmers to determine a formal, documented testing plan to ensure the feature or fix is functioning as expected and matches approved specifications
  • Liaise with client support specialists to ensure that testing plan for client jobs will meet client needs
  • Perform & sign off prescribed testing of feature in line with the release schedule
  • May include developing job-specific data to be used for future testing by the QA team
  • Analyze the results of tests of tests that you have performed and provide meaningful reports to the programming team
  • Participate in Interest Groups and Working Groups
  • Manages the day-to-day operations of a QA team and provides oversight, development and performance management to staff
  • Assesses priority of projects and monitors work assignments ensuring adequate resourcing to meet client project timelines and provides quality deliverables
Qualifications for QA associate
  • Ability to work simultaneously with several subjects between interactions and distractions
  • Language Requirement – English Business Fluency
  • Experience and knowledge of cGMP requirements and internal standards
  • Willingness to travel occasionally within the US (less than 10%)
  • Experience in investigations writing and review preferred
  • Must have a degree / higher education
4

QA Associate Job Description

Job Description Example
Our company is searching for experienced candidates for the position of QA associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA associate
  • Responsible for ensuring work area is clean and organized, which includes daily and monthly self-audit participation, corrective actions, and preventive measures
  • Must follow all Safety procedures and Good Manufacturing Practices
  • Regularly communicate with internal staff and customers through email and voice mail
  • Developing, maintaining, executing and documenting tests on AXIS
  • Documenting and reporting problems
  • Liaise with developers resolve issues
  • Ensuring the integrity of the test material
  • Preparing versions for release to clients
  • Assist with development and maintenance of in-house testing and tracking software
  • Involvement in providing client access to software (module access, keys)
Qualifications for QA associate
  • No previous experience in software testing required
  • Ability to review, analyze, and verify income documents such as personal tax returns, bank statements, credit reports
  • Ability to lead cross-functional departmental teams
  • Ability to effectively teach, coach and mentor
  • Demonstrated knowledge and experience of Nonconformance & MRB (Material Review Board) processes, and FRB (Failure Review Board) processes
  • Understanding of Test Readiness Reviews, Manufacturing Readiness Reviews
5

QA Associate Job Description

Job Description Example
Our company is hiring for a QA associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QA associate
  • Record and track all issues uncovered during requirements review or testing and follow through to resolution
  • Applies good debugging and troubleshoot techniques to assist Developers with isolating the problem and determining th
  • Review and approve documentation for incoming materials to ensure compliance with Quality System, including DVH (Device History Record)
  • Prepare and review procedures and documents supporting QMS (Quality Management System) compliance
  • Evaluate the functions of the quality group to continuously improve the QMS
  • Collaborate with area management to develop training curriculum that are linked to the job roles
  • Identify and implement systems to assure that training records for site personnel are complete, accurate, and compliant and archived on an on-going basis
  • Participate in implementing systems that provide for compliant determinations of post-training effectiveness
  • Facilitate or conduct instructor led training for new hire, annual QSR/ISO requirements, document revision training, and ongoing cGMP topics
  • Participate in the development of Annual Training Plans for plant and employees
Qualifications for QA associate
  • Understanding of PDR (Preliminary Design Review) and CDR (Critical Design Review) support
  • Existing Secret clearance a plus
  • Lean Six Sigma, ASQ certification or other professional certification
  • Familiarity with basic laboratory instrumentation
  • Able to work with limited supervision for routine tasks
  • Ability to stand/walk/stoop during a complete 8 hour shift

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