Associate, QA Job Description

Associate, QA Job Description

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Associate, QA provides quality oversight and support to drug product and drug substance contract manufacturing operations in the following key areas; batch record, analytical laboratory operations, equipment and facility, and materials management.

Associate, QA Duties & Responsibilities

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

Sample responsibilities for this position include:

Listens, evaluates, and scores agent’s calls based on current quality guidelines
Provide expertise and guidance in interpreting USDA governmental regulations, and agency guidelines, to assure compliance
Develop and implement processes and procedures to assure a best-in-class compliance-oriented environment meeting internal and external requirements and standards
Constructively challenge, and actively participate in, management decision-making processes related to tactical business issues
Adapts quickly to new technologies and processes
Assisting in implementing quality systems
Supporting the Quality Assurance Department
Implementing the Quality standards of the process
Assisting with distribution of goods in process and finished goods records and documentation
Interacting with other departments and team members

Associate, QA Qualifications

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

Licensing or Certifications for Associate, QA

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

Education for Associate, QA

Typically a job would require a certain level of education.

Employers hiring for the associate, QA 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 Associate, QA

Desired skills for associate, QA include:

Process and facility equipment
Java
Adobe Experience Manager and Content Management Systems
Guidelines
JIRA Application
LIMS
Macros and visual basic writing in MS Excel
Accessibility testing
Electronic Batch Record
Processes

Desired experience for associate, QA includes:

Assisting and writing procedures for distribution and delivery of medical devices
Assisting in writing employee training procedures in respect to OSHA, safety and health requirements
Assisting with process flow charts of medical device life cycles
Assisting in creating the SQA project toolkit
Assisting in defining the SQA methodology to include test phases and associated terminology
Assisting in implementing SQA software and tools in a lab environment for use by multiple parallel projects

Associate, QA Examples

1

Associate, QA Job Description

Job Description Example
Our company is growing rapidly and is hiring for an associate, QA. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate, QA
  • Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions
  • Performs various inventory transactions on the ERP system
  • Our mobile apps are a growing part of our business here at Hotels.com
  • The candidate will be working in a fast paced environment and will need to work well within our team, on multiple apps & with the latest technologies
  • Understand expected behaviour of our products and find deviations thereof
  • Conduct regular evaluations of Credit loan and documents review
  • Conducts, audits, reviews, and analyzes documentation
  • Uses the available resources to provide written feed-back and enhance member satisfaction
  • Provides recommendations on improvements to Management
  • Ensures that data and information are accurate and reliable
Qualifications for associate, QA
  • Master degree in Chemical/Pharmaceutical sciences or equivalent by experience
  • Proficiency in computer applications such as MS office is preferred
  • Danish and English
  • Experience from pharmacy or pharmaceutical industry will be beneficial
  • Minimum four (4) years of relevant experience in documentation review, QA or equivalent exposure
  • Minimum one (1) year of batch review experience
2

Associate, QA Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of associate, QA. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate, QA
  • Creates and maintains automated tests for high availability and highly scalable applications which will be used by both internal and external customers
  • Practical knowledge in analyzing, designing, and developing solutions to highly complex technology problems
  • Awareness of technology and product trends, especially what is happening in open source
  • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
  • Completes investigations of customer complaints
  • Assist in validation of manufacturing and production lines and equipment pertinent to microbiology
  • Assist in coordination of End to End and User Acceptance testing activities
  • Execute test plans designed by Senior Quality Assurance Analysts
  • Create and manage bug reports to be addressed by the development team
  • Work with Business Analysts to ensure all configuration documents are placed on our online file repository
Qualifications for associate, QA
  • Assess gaps between local procedures, corporate standards and regulatory expectations specifically as it relates to FUME
  • Observe, promote, and comply with requirements related to safety, quality, security, customer service, and GMPs
  • Escalate notification to management for departures of critical nature and assure issues are addressed
  • Ensure area is audit ready at all times
  • Assess deviations for potential to impact product SISPQ and assure proper root cause identification and establishment of effective corrective actions to prevent recurrence
  • Ensure investigations are completed in an appropriate and timely manner
3

Associate, QA Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of associate, QA. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate, QA
  • Has input to test coverage based on business requirements, user stories and application design
  • Creates and executes manual and/or automated test scripts for multiple or complex projects
  • Creates test data for multiple or complex projects
  • Performs testing for multiple or complex projects & retests as necessary
  • Reviews and reports complex test results
  • Identifies test issues on multiple or complex projects
  • Executes regression tests for projects
  • Participates in production verification and validation
  • Perform activities associated with disposition of raw materials and product
  • Responsible for the process of document control, including managing drafts, editing, approval, change control, distribution and archiving, of all controlled documents
Qualifications for associate, QA
  • Make decisions and exert good judgment
  • Must exhibit attention to detail and have good teamwork and interpersonal skills
  • Experience in conducting root cause investigations, and execution of change management
  • Ability to communicate effectively with customers to enforce requirements
  • Fundamental knowledge of computer applications
  • Ability to stand for extended periods of time to support production needs
4

Associate, QA Job Description

Job Description Example
Our growing company is hiring for an associate, QA. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate, QA
  • Assists senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
  • Evaluates audit and inspection findings produced by QA staff and determines appropriate departmental interpretation
  • Participates in client and regulatory inspections in order to provide information regarding the QA program and facilitates responses
  • QA Paperwork Review to ensure that supplier approval, certification, and quality perimeters have been met prior to release of any ingredients, packaging, and / or finished products
  • Handling of Ingredient & Packaging Release Program via the Oracle System including review and enforcement of incoming COAs for ingredients and food contact packaging specifications
  • Submission of Supplier Complaint data along with all supporting documentation
  • Assist in the creation of Standard Operating Procedures as directed by the Quality Assurance Manager
  • Assist in Food Safety and Quality Training as directed by the Quality Assurance Manager
  • Assist in the development of a sensory evaluation program for ingredient & finished product with the Quality Assurance Manager
  • Manage any and all HOLDS from assigned shift and ensure product, material disposition is in compliance with Food Safety and Finance requirements
Qualifications for associate, QA
  • Ability to prioritize for maximum results (multi-task management)
  • Identify, record, and document defects found while testing
  • Maintain and update test code in QA testing environments
  • 0 to 2 years of hands-on black/white box testing experience
  • Strong understanding of engineering requirements
  • A working knowledge and understanding of requirements flow-down, product acceptance activities, and/or manufacturing process oversight
5

Associate, QA Job Description

Job Description Example
Our company is looking for an associate, QA. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate, QA
  • Properly document and maintain records of all OOSs
  • As designated and under supervision of QA/QC Manager or Site Director, interact with clients about complaints or other quality issues
  • Assure compliance with cGMP regulations, ISO 17025 and company procedures (SOPs and QSMs)
  • Represent and interact with multiple departments to provide cGMP guidance in an effective manner
  • Troubleshoot and take the initiative on any QA-related issues with regards to cGMP compliance
  • As designated and under supervision of QA/QC Manager or Site Director, written reports of any corrective actions or preventive actions (CAPAs) investigated
  • Assist with developing, revising, and reviewing SOPs
  • Assist with performing quality review of drug and OOS results review of ongoing studies
  • Support all other QA/QC functions as required
  • Co-ordinate cross-team test activities
Qualifications for associate, QA
  • Ability to sit and work at a workstation for extended periods of time
  • Bachelor’s degree in Chemistry, Biology, or Pharmacy
  • Knowledge, practical application, and understanding of microbiology
  • Bachelor’s degree or above in an Engineering/Technical discipline
  • Experience to communicating and influence others in a concise, data driven manner (eg
  • Experience evaluating supplied products performance and the working knowledge of continuous improvement methods required to insure improving

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