Quality Assurance Associate Job Description
Quality assurance associate
provides initial and ongoing annual training for GMP, GTP, GCP, GLP, and GDP for all staff.
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:
Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory
Reviewing Batch Records and/or Device History Records (DHRs) to verify calculations, product accountability, accuracy and proper GMP documentation practices and prepare them for final review and product release
Contribute to implementation and training efforts to ensure site is compliance with relevant state & FDA regulations
Become intimately familiar with company Standard Operating Procedures (SOPs), FDA, OECD, and MLHW regulations, and other appropriate guidelines and regulations
Identify product specification issues related to country of origin, pack size, decay, scarring and other USDA/FDA guidelines
Reviewing quality documents and preparing them for product release
Tracking Errors in Batch Records and/or DHRs
Collecting and reporting metrics in a complete, user friendly, and timely manner
Participating in the development of quality performance measures (KPI)
Producing metrics based reports (written and graphic)
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:
GMP
Excel
Electronic databases
FDA
GLP
GTP
MS Word
Microsoft Office applications
More complex disciplines
Access
Desired experience for quality assurance associate includes:
Preparing and distributing the monthly Quality Assurance metrics report and other reports
Assisting with managing CMOs and Clinical Suppliers
Exhaustive functional testing of Middle Office Services applications
Test and Defect Management in Jira and HP ALM11
Participate in sprint test planning activities - based on functional specifications provide user stories point estimation, test cases, test data, test environments, test effort
Communicates with impact – expresses thoughts and ideas in a clear, succinct, and compelling manner in both individual and group situations
Quality Assurance Associate Examples
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Quality Assurance Associate Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality assurance 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 quality assurance associate
- 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
Qualifications for quality assurance associate
- 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, ..)
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Quality Assurance Associate Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality assurance 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 quality assurance associate
- 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
Qualifications for quality assurance associate
- 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
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Quality Assurance Associate Job Description
Job Description Example
Our growing company is hiring for a quality assurance associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance associate
- 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
Qualifications for quality assurance associate
- 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
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Quality Assurance Associate Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of quality assurance associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality assurance associate
- 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
Qualifications for quality assurance associate
- 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)
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Quality Assurance Associate Job Description
Job Description Example
Our growing company is looking to fill the role of quality assurance associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality assurance associate
- 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
Qualifications for quality assurance associate
- 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