Quality Specialist Senior Job Description
Quality specialist senior
provides quality oversight of QC Chemistry and QC Microbiology as well as Supply Chain, Warehouse, Manufacturing Operations and ECQ.
Quality Specialist Senior Duties & Responsibilities
To write an effective quality specialist senior job description, begin by listing detailed duties, responsibilities and expectations. We have included quality specialist senior job description templates that you can modify and use.
Sample responsibilities for this position include:
Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation
Perform targeted process/control reviews
Evaluate control effectiveness for a specific process
Provide and write issue summarizations for Quality reporting purposes
Develop written communications and presentation materials
Maintain working relationships with business partners
Complete step by step procedural reviews of COAL cases/functions
In depth research of criminal orders
Collaboration with Management, Legal, and Training
Identify procedural gaps
Quality Specialist Senior Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Specialist Senior
List any licenses or certifications required by the position: ASQ, ISO, CQE, PMP, ITIL, SWPPP, TSE/BSE, CQA, GMP, QA
Education for Quality Specialist Senior
Typically a job would require a certain level of education.
Employers hiring for the quality specialist senior job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Science, Chemistry, Education, Biology, Technical, Microbiology, Health Care, Business/Administration, Information Technology
Skills for Quality Specialist Senior
Desired skills for quality specialist senior include:
Chemistry and biologic systems
Protein chemistry
Agile PM methodology will be an advantage
Aseptic processing
CGMPs
Manufacturing operations
Quality Control techniques and testing methodologies is beneficial
US/EU cGMPs for the biotech/pharmaceutical industry
Validation principles
With an understanding of worldwide regulatory affairs
Desired experience for quality specialist senior includes:
Biotechnology qualification/background a strong advantage
ISO 13485/9001 Internal Auditor required
Become proficient in all COAL work streams
Track, log, and report all defects found
Maintain strict confidentiality of all information
Completed 1 year of employment within COAL
Quality Specialist Senior Examples
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Quality Specialist Senior Job Description
Job Description Example
Our company is hiring for a quality specialist senior. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality specialist senior
- Developing and executing manual and automated tests to ensure functional and non-functional requirements (performance, resilience, scalability, usability, security, and corporate compliance) are satisfied
- Analysing problems and tracing the root cause of a failure or problem
- Staying abreast of the latest developments in technology and industry best practices and identifying where they can be incorporated to bring continual improvement to the testing process and tooling
- Managing the definition, implementation, and integration of quality principles into the design and development of software and IT processes
- Interface with Halozyme QC, Manufacturing, Supply Operations, Product Development, Regulatory Affairs, and other disciplines in support of Halozyme’s goals and initiatives for the product
- Generates daily, weekly, and monthly Quality System trending reports
- Serve as the SME/primary contact/lead between Global Manufacturing sites and J&J Medical Canada for product hold process
- Reviews Quality System documentation, including Production Batch Records, Variances, and Quality Analysis Reports (QARs), and appropriately dispositions affected materials
- Manages workload to ensure manufacturing and product launch schedules are met
- Assist with on-site assessments for local Client Service groups (CSG)
Qualifications for quality specialist senior
- Deep knowledge of Good Clinical Practice (GCP) regulations and guidelines
- Effective communication skills at all levels both written and verbal ( English and Spanish)
- BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science)
- Applied knowledge of applicable regulatory, Corporate and or Unit
- Knowledge and understanding of various software packages, specifically Microsoft Office, LIMS, SAP, TrackWise, IDEA
- Ability to work at a fast pace and handle multiple tasks, work with interruptions, prioritize workload, and deal effectively with confidential information, understand and implement written and verbal instructions
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Quality Specialist Senior Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality specialist senior. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality specialist senior
- Develop and deliver quality systems training
- Use prior experiences to help problem solve, search and apply solutions
- Develop internal quality self-assessment program and internal auditors
- Manage Quality Incident reporting and CAPA system to prioritize and ensure follow up on corrective and preventive action plans
- Complete work according to established priorities to assure deliverables meet requirements
- Develop and implement plant quality systems, provide coaching and guidance to Operations and R&D on system requirements and strategies to manage compliance
- Proficiency in using software systems such as
- Experience in writing and revising procedural documents, troubleshooting and root cause investigation
- File and archive documents owned by QA, and provide timely documentation & training support during the preparation for and execution of external audits
- Escalation of complaints and assist in complaint investigations as required
Qualifications for quality specialist senior
- Bachelor’s degree in Biology, Chemistry, Microbiology, or related field and at least three years of technical experience working in the laboratory, or an Associate’s degree with commensurate experience
- Must be willing to participate in random drug screening
- Review the functional test cases written by the test engineers to make sure there is adequate test coverage
- Broad knowledge and experience performing assays used to assess the quality of biopharmaceuticals, including HPLC, SDS-PAGE, CE
- Proven ability to establish collaborative working relationships
- Maintain productive relationship and open communication with QC, Supply Operations, Regulatory, Manufacturing, Product Development, Research and Development, Project Teams, and Clinical Research/Operations
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Quality Specialist Senior Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality specialist senior. 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 specialist senior
- Initiation (if required), reviewing, monitoring and approval of Logistics change controls to ensure targets are achieved in a timely manner
- Support Logistics staff in the initiation of change controls in Trackwise
- Generate Lot Distribution Report semi-annually as per FDA requirement (responsible)
- Plan scope and schedules the audit with suppliers
- Generate audit metrics to be reported to Quality Lead Teams (QLTs) - Department Level and Quality System Level
- Verify vendor addresses to ensure the Approved Vendor List (AVL) is accurate to support with regulatory submission activities
- Consult with CMC & Patient Safety QA team members and Supply Chain stakeholders to complete the Supply Chain Map
- Support GMP, GDP and GVP’s 2017 vendor management improvement initiatives and the development of vendor score card tool
- Primary responsibility is to provide quality review & approval of validation activities associated with changes to existing systems & projects that support site
- Presentation & support for validation concepts & approaches with audits & inspections
Qualifications for quality specialist senior
- 5+ years' experience working within a regulated environment
- Sense of urgency, results and performance driven – works independently with minimum supervision
- Ability to apply risk management philosophy to business processes, decisions and data
- Experience in tools like JIRA, TestLink, VersionOne, SVN, JAWS, SoapUI and ANT is a plus
- Geek factor, able to speak XML, HTML, comfortable with API, web services, knowledge of how the platforms that comprise a SaaS are put together
- Knowledge of CSS, or JavaScript is a plus
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Quality Specialist Senior Job Description
Job Description Example
Our company is looking for a quality specialist senior. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality specialist senior
- On-the-job training in quality tools and methodologies
- Evaluate the value and impact of both ongoing and completed quality improvement projects
- Capture dispersed product data and intelligence into a cohesive, actionable portfolio
- Communicate product quality portfolios to applicable management teams
- Solve challenges related to customer complaints, product performance and product quality, working with both R&D and Sustaining Engineering teams
- Identify and execute on process and product improvements along with Sustaining Engineering and third-party suppliers
- Team with R&D to establish and execute Quality Plans for new products
- Incorporate Water Purification into the established site Quality Management System and ISO 9001 certificate
- Partners with UAT Test Lead on alignment of UAT testing
- Provides leadership to test analyst resources, which includes assigning tasks or work, holding regular status meetings and reporting, setting context, mentoring and coaching, in order to create and maintain a high-performing team
Qualifications for quality specialist senior
- Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field
- Experience in QMS platforms a plus
- Degree calibre candidate with expertise in business or economics related subjects
- 10+ years In Quality related construction activities
- Current cGMP knowledge having a good understanding of GCP and the ability to support the Clinical teams across the company
- Experience working in both team setting and independently
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Quality Specialist Senior Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality specialist senior. 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 specialist senior
- Develops, implements and ensures compliance of quality assurance plans for production processes to ensure product specifications (quality and safety) are met
- Identify and implement corrective actions to reverse negative trends in manufacturing related consumer complaints
- Contribute and support internal and external team Sharepoint sites
- Perform specialty audits, as requested by management
- Execute on supplier qualification activities, such as Supplier Corrective Action Requests, performing supplier audits, and writing audit reports
- Interact with lab operations personnel to ensure compliance with company quality systems policies and procedures
- Support final review and release of material produced in-house and at contract manufacturers
- Develop/Execute automated tests, identify critical bugs quickly and work with Engineers to resolve them
- Develop effective tests to cover all scenarios for both iOS and Android Mobile applications
- Stay on top of all bugs, help triage bugs and driving issues to resolution and keeping everyone involved aware of QA status
Qualifications for quality specialist senior
- Masters or Degree in Chemistry, Pharmacy, Biochemistry, Microbiology or related discipline (Biotech preferred) or experience in Sterile Manufacturing
- Minimum 5 – 8 years’ experience in pharmaceutical GMP-regulated industries (Biotech preferred) and minimum 5 years in Quality Assurance or Compliance
- Hands-on working experience with GMP documentation and/or training systems is a must
- BS/MS in Chemistry, Biology or related science in a relevant discipline
- Requires ability to work independently and on teams,managing multiple projects/tasks simultaneously with competing priorities
- Experience with Pilgrim SmartSolve and TrackWise QMS preferred