Quality Assurance Associate Job Description
Quality Assurance Associate Duties & Responsibilities
To write an effective quality assurance associate job description, begin by listing detailed duties, responsibilities and expectations. We have included quality assurance associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Quality Assurance Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Assurance Associate
List any licenses or certifications required by the position: ASQ, IBWA, SQF, HACCP, ISO, API, 9000, QS, GS1, ACAMS
Education for Quality Assurance Associate
Typically a job would require a certain level of education.
Employers hiring for the quality assurance associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Education, Engineering, Biology, Technical, Manufacturing, Associates, Business, Computer Science
Skills for Quality Assurance Associate
Desired skills for quality assurance associate include:
Desired experience for quality assurance associate includes:
Quality Assurance Associate Examples
Quality Assurance Associate Job Description
- Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7 and related guidance’s, FDA regulations
- Through a quality system approach, ensure all GMP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence
- Along with the QA staff, be responsible for the release or rejection of GMP materials
- Responsible for executing QA operations required to assess, evaluate, and review operations on the floor (as defined above) against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation
- Provides continuous improvement ideas in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems
- May be asked to serve as a Subject Matter Expert for internal matters
- Creates and provides general, standardize and customized training to all employees including new hire, refresher and just in time training on minor enhancements
- Manage product complaint investigations, initiation through closure
- Provide high-level input as to the testing approach and methodology to be used in the testing of each application
- Develop, execute, validation and audit PCBA and System test packages for Setup Box products and related products
- Excellent oral and written communication skills with the ability to interact at all levels both internally and externally
- Frequent side-to-side turning of neck, walking, standing, bending and stooping, pushing/pulling, twisting at waist, moderate wrist torque to twist equipment knobs and dials, lifting objects weighing up to 20 lbs
- Occasional squatting, kneeling, reaching above and at shoulder height, moderate grasping to manipulate reference books and manuals, lifting objects weighing 20-35 lbs
- Preference will be given to those with an Associate Degree or Bachelor Degree
- Must be a self-starter, able to work independently be part of a team
- At least 2 years of work experience with ISO 9001 or other Quality Management Standards (ISO 13485, AS9100, ..)
Quality Assurance Associate Job Description
- Provide quality oversight and review to AMRl's validation program including process validation, cleaning validation, computer software validation, and instrument qualification
- Oversee the site's quality assurance program
- Support onsite inspection by regulatory agencies and customers
- Identify and lead operational excellence initiatives, both in the department and companywide
- Provide hands-on QA support in the MBR and EBR review including batch release as needed
- Recommends and conducts projects to improve the efficiency and effectiveness of the quality system
- Manages compendia changes
- Establishes and maintains effective work relationships within the department, the Company and the community
- Develops self to improve performance in current role and to prepare for future roles, and seeks and provides feedback and coaching to enhance performance
- Ensure application is tested and scanned to a high quality
- Demonstrate flexibility with work assignments, time, and work schedule
- Bachelor’s degree, from an accredited institution, in Biology or Chemistry is preferred (or closely related degree with these core courses as the foundation) plus two (2) to four (4) years of Quality Assurance experience
- In lieu of a Bachelor's Degree, High School Diploma with a minimum of six (6) to eight (8) years biopharmaceutical industry experience with cGMPs in areas described in this profile
- Demonstrated knowledge of relevant regulations and guidances
- 6+ months writing Java
- 6+ months writing Javascript
Quality Assurance Associate Job Description
- You will be involved in a variety of duties associated with the release of drug products to market and stability studies in accordance with GMP regulations
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies
- Electronic Document Control activities as assigned
- Provide training to personnel as assigned by supervisor
- Supports regulatory audits as required
- Conducts orientation training for new employees
- Ensures that all documents in ENNOV are maintained, administered accurately and remain current
- Archives completed documents and records
- Observes and supports all safety guidelines and regulations
- Identify defects by inspecting defective merchandise of apparel and non-apparel items
- Bachelor of Science or Associates Degree
- Strong verbal and written communication skills bilingual English/Spanish is a plus!
- To thrive in this role, you must have a “roll up your sleeves” mentality, take initiative and set high personal standards
- BS in Biological Sciences, Chemistry or relevant discipline preferred
- A minimum of 3 years relevant experience in the pharmaceutical/biotech industry
- Experience in deviations, investigation, determining root cause, and developing corrective action plans
Quality Assurance Associate Job Description
- Producing test results every day and analyzing and debugging issues
- Finding the root cause of the issues and ensure timely resolution
- Collaborating with global teams and keeping test suites up to date and improve its coverage
- Automate processes and remove manual interventions
- Improving the quality and coverage of the testing
- Developing tools to improve monitoring, reporting test results
- Be responsible for managing a team of QA engineers
- Deep understanding of automated test frameworks and suites to enable engineering team to run, and view results of automated functional and non-functional software tests
- Where necessary, develop and execute manual test cases to detect issues that cannot be detected through automated means
- Provide solution implementation to team members for system and integration testing, and user training
- Minimum of HS degree, Associates preferred
- SAP experience – Quality module preferred
- Bachelor’s degree in communications, education, or a related field
- Minimum of two to five years of experience, preferably within an organization focused on editing, education, curriculum development, or a related field
- Experience working with assessments is preferred, but not required
- Technologically proficient (especially with Microsoft® Office, Google programs, and HTML experience)
Quality Assurance Associate Job Description
- Deliver software application testing results on time and within scope and budget
- Contribute to the quality assurance of application and information architecture planning, design and implementation by developing application testing plans
- Conduct comprehensive data integration testing to support data exchange across enterprise systems
- Review and provide input for system requirements and design
- Conduct deployment testing activities
- Share testing results and knowledge with project team members to improve and innovatively deliver products
- Communicate periodically with project and test managers to provide updates on testing status and results
- Test reports and review quality assurance (QA) of corporate data, taxonomies, business information, and institutional capability information in systems of records
- Provide test cases to software training manager and associate to assist in the development of training materials
- Perform ongoing reviews of the DDO Operational team to ensure controls/standards with expansion to cover KYC reviews across Asset Management and CIB Lines of Business
- Knowledge accessing relational databases
- New graduates with internships in this field will be considered
- Bachelor’s degree in quality, life sciences, or engineering related field
- 3+ years experience testing Android and/or iOS applications
- Experience Testing APIs, backend and frontend application layers
- Ability to innovate and simplify