Quality Associate Job Description
Quality associate
provides quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Quality Associate Duties & Responsibilities
To write an effective quality associate job description, begin by listing detailed duties, responsibilities and expectations. We have included quality associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Coordinate and execute cGMP stability studies
Implement adequate communication processes and maintain CMO partnership Authors, revises and/or reviews Shire Standard Operating Procedures, Guidance Documents, Technical/Quality Agreements, and other documents as assigned
Facilitating the resolution of complex issues
Ad hoc projects, and coverage as necessary
Batch records
Manage and lead the regulatory affairs team to ensure that all regulatory deliverables are met in compliance with local and international regulations applicable to clinical trials supply chain activities
Ensure compliance with applicable Corporate and Divisional Quality Policies and procedures
Responsibility for management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions through to resolution
Identify regulatory and quality training needs, and delivering training
Leads liaison with regulatory bodies , clients and key suppliers on audit, regulatory, and quality related matters and to provide guidance and advice to clients, suppliers and internal associates on regulatory and quality matters
Quality Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Associate
List any licenses or certifications required by the position: ASQ, CQE, CQA, GS1, ISTQB, ISEB, QP, QE, EPIC, RA
Education for Quality Associate
Typically a job would require a certain level of education.
Employers hiring for the quality associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Guidance, Engineering, Science, Chemistry, Education, Technical, Biology, Business, Computer Science, Manufacturing
Skills for Quality Associate
Desired skills for quality associate include:
FDA Regulations
Application of Good Laboratory Practices
Application of Good Manufacturing Practices
Outlook
CGMP
ICH
GLP
Processes
Excel and Outlook
MS Office
Desired experience for quality associate includes:
Maintain orderly electronic files for each file tested, evidencing how data was validated (e.g, pdf’s of source documents showing DQA checks) and issues resolved
Coordinate Testing activities with various groups (Development, Infrastructure, Database ) �
Bilingual in Spanish or Korean preferred
Experience working in a fast-paced environment preferred
Must be proactive and take accountability for assigned projects
Ability to communicate with a variety of people
Quality Associate Examples
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Quality Associate Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of quality 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 quality associate
- Must be recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability
- Ability to organize and communicate complex information that engages the audience
- Ability to articulate customer needs and incorporate into work product
- Ability to make routine decisions independently
- Ability to design experiments and draw meaningful conclusions from lab data
- Lead and support on-site audits and review of 3rd party audit reports / corrective action responses
- Perform compliance assessments related to aseptic fill operations, solid dosage operations, and laboratory functions Take appropriate actions during oversight activities to ensure adequate controls in relation to the level of product quality, safety, and business risks
- Lead complex investigation events and escalate action plans and product dispositions as warranted
- Provide leadership and quality team participation as assigned related to site initiatives and customer project teams
- Support Supplier Quality related activities, Supplier qualification and monitoring
Qualifications for quality associate
- Must have a demonstrable record of implementing and maintaining a total quality system
- Successful development and implementation of a quality strategy for a commercial manufacturing operations environment
- Experience testing XML and Gateway/OAGI messaging, workflow alerts and notifications is preferred
- Knowledge and understanding of Global regulations pertaining to drug and device complaint management (eg
- Evidence of leadership skills coupled with good oral and written communication skills, effective presentation of concepts and ideas, interpersonal and conflict resolution skills
- Knows and applies the fundamental concepts, practices, and procedures of the quality engineering profession
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Quality Associate Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality 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 associate
- Develop implementation plans and standards and/or leads the planning and implementation for critical improvement processes
- Gauge and evaluate effectiveness and assure continuous improvements of previous audits
- Review and approve D&D documents including protocol and reports for quality and scientific content (business language is English)
- Analysis of customer rejected martial
- Maintain Plant Food Safety Plan
- Manage the GMP program
- Provide leadership, support and backup for Quality Technicians
- Coordinate non-conforming product issues including identification, segregation, disposition, tracking, and corrective action of non-conforming product
- Establish and maintain plant sanitation program including detailed written procedures for the cleaning of all processing equipment and facilities
- Coordinate elements of the allergen control program including ingredient labeling, segregation, storage, cleanup process, verification of cleanups, and validation of cleanups
Qualifications for quality associate
- CQE preferred
- Experience in implementing and leading TPM and Quality Pillar activities
- Experience with management systems (ISO 9001 preferred)
- Demonstrate knowledge in Ontario Health and Safety regulations
- Ability to identify and lead problem solving and continuous improvement projects
- Ability to interface with all levels of organizations both internally and externally
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Quality Associate Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality associate
- Preparing risk analysis
- Proposing and implementing system to track Batch record update at CMO in compliant and simplified manner
- Using established inspection/test procedures performs basic incoming inspection/test of components subassemblies and materials (written video ) sometimes under the supervision of higher level inspectors and/or technicians
- Exercise limited judgments in identifying workmanship and material defects
- May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner
- Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions)
- Serve as a SME for operations is a regulated environment (GMP)
- Transition culture to a lean thinking enterprise using principles of Muda, Muri and Mura
- Write and review validation protocols
- Serve as Quality core team leader/member on project teams
Qualifications for quality associate
- Climbing to various heights via stairs or ladders on a regular basis
- Pushing/pulling various plant materials and/or equipment
- Will maneuver in cramped/confined spaces
- Frequent bending and/or crawling
- Driving a company or rental vehicle for up to 8 hours if needed
- Candidate must possess strong interpersonal skills along with verbal and written communications
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Quality Associate Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality 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 associate
- Conduct dimensional and visual final inspections for product releases
- Compile and initiate Production Part Approvals (PPAP) in support of design engineering and supplier transition efforts
- Improving customer experience based on the analysis of the assortment quality
- Lead projects to achieve a high product quality for marketplace
- Communication between customers and departments
- Analysis on seller assortment quality performance, brand certifications and IP rights
- Recommend actions and find solutions for affected products and sellers
- Coordinate with Content, Customer Service, Customer Experience, Partner Support Center and Warehouse teams for fast and efficient responses of customer and seller requests
- Coordinate with the Assortment Quality Manager and Head of Marketplace Operations on internal process enhancement
- Monitor and review the success of implementations
Qualifications for quality associate
- Familiarity with telecommunication products and design
- 1-2 years in a Quality Control laboratory or flow cytometry experience
- A basic knowledge in various computer applications
- Employees must work in areas were posted Universal Precautions must be observed and practiced
- Participate to the internal audit program as auditor and support the follow-up of the audit to improve the Quality knowledge of departments
- Participate to External Inspections on an as needed basis (MOH, FDA, ISO13485)
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Quality Associate Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality 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 associate
- Initiate corrective action requests on discrepant product/processes and verify adequacy and accuracy of corrective action taken internally and/or externally
- Manages the facilities environmental microbiological program including the coordination of all sampling, the tracking of results, the implementation of corrective actions, and the on-going verification and validation of the program
- Investigates food safety consumer/customer complaints, identifies appropriate corrective action, and provides professionally acceptable written resolution as needed to the platform Q & FS group and Customers
- Coordinates the facility’s food safety self-inspection program in support of the facility’s internal audit program
- Support Crosstex quality systems at site including audits, CAPA, validation, and change control
- Assist with document control activities
- Performs the accurate execution of any and all PCT and/or client test methods and procedures of cellular products to ensure the Safety and/or Efficacy of different cell populations
- Ability to lead or coordinate projects within own department
- Medical Record Retrieval and Processing, utilize departmental tracking tool to request and retrieve Medical Records
- Transcribe, format, input, edit, retrieve, copy, and transmit text, and data
Qualifications for quality associate
- Excellent understanding of basic laboratory functions (pipetting, making buffers)
- Very smart with a great attitude and a willingness to work hard with the team
- Experienced in word processing programs spreadsheet applications
- Extremely high proficiency in technical writing
- Extremely high proficiency in Microsoft Word
- Demonstrated ability to effectively integrate into a team environment