QA Specialist / Senior Specialist Job Description

QA Specialist / Senior Specialist Job Description

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QA specialist / senior specialist provides continuous improvement in quality through the projects with good compliance to global PQS standards including GMP and local regulations.

QA Specialist / Senior Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Ensuring device contract manufacturing and testing operations, supply chain operations, and supplier quality activities are in accordance with ISO 13485, ISO 14971, EU MDDs & relevant US FDA 21 CFRs
Reviewing all non-conformances/ deviations
Prepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controls
Reviews and approve deviations and change controls related to DP and FDP
Execution of quality systems relating to devices and maintaining and improving quality metrics for medical device products
Reviewing, maintaining & reporting on the compliance of medical device QMS
Participation in QA operational device activities, including change controls, non-conformance/deviation investigations, complaints, CAPA, CAPA effectiveness, batch disposition
Approval of aforementioned Quality system records
Support of inspection readiness activities
Support of device contract manufacturers including day to day operational activities, resolution of issues, Quality management Reviews, reporting on performance and other QS-related process improvements

QA Specialist / Senior Specialist Qualifications

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

Licensing or Certifications for QA Specialist / Senior Specialist

List any licenses or certifications required by the position: ASQ, ISTQB, MBTA, ISO, SOP, DFSS, CMQ/OE, GCP, QC, PCQI

Education for QA Specialist / Senior Specialist

Typically a job would require a certain level of education.

Employers hiring for the QA specialist / senior specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Engineering, Chemistry, Biology, Computer Science, Technical, Education, Pharmacy, Biotechnology, Management

Skills for QA Specialist / Senior Specialist

Desired skills for QA specialist / senior specialist include:

Defined SOPs & policies
GMP and quality processes to actively identify
Testing theory and ability to apply it in practice
Suggest and participate in continuous improvement activities
SOX
PCI
Industry methodology standards
Applicable data privacy and security practices and laws
Microsoft technology stack
SQL

Desired experience for QA specialist / senior specialist includes:

Maintain Quality Plans, Quality Agreements, and specifications with manufacturing partners
Lead external audits independently as lead auditor
Lead meetings with external parties and representing Shire in a professional manner
Support development activities, particularly design transfer of new products and design changes on commercial products
Lead Shire QA projects, including communication and status reports to Shire Stakeholders
Serve as QA representative on cross-functionally-led projects

QA Specialist / Senior Specialist Examples

1

QA Specialist / Senior Specialist Job Description

Job Description Example
Our company is growing rapidly and is hiring for a QA specialist / senior specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA specialist / senior specialist
  • Provide QA support to initiate, engage and escalate major and critical compliance issues through the site QMS processes deviations and CAPAs
  • Liaise with the Quality Manager/Qualified Person, as necessary, on technical issues including deviations, CAPA
  • Reviews, assesses and approves deviations and change controls
  • Reviewing and releasing of all records associated with external manufactured product
  • Conducting record review of executed batch records from CMO operations
  • Performing review of records (e.g CoA, CoC, ) and testing results
  • Initiating and/or reviewing non-conformances, CAPA's and Change Management
  • Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record review
  • Performing review of bulk drug product executed records, if needed
  • May own CAPAs associated within the QA unit
Qualifications for QA specialist / senior specialist
  • Experience with a breadth of medical devices (class I, II, III, or spanning range from kits to diagnostics to implantable devices) preferred
  • Experience with supplier quality and post-market operational activities
  • Experience conducting audits independently as lead auditor
  • Experience with mobile device management tools like XenMobile, MobileIron, or similar tools a plus
  • Living the values at Shire is a basic expectation for all Shire employees/contractors
  • BS in Engineering and or Science and a minimum of 3 years of project management, process excellence, and/or project support experience with increasing responsibility in the areas of Quality Assurance
2

QA Specialist / Senior Specialist Job Description

Job Description Example
Our growing company is looking to fill the role of QA specialist / senior specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QA specialist / senior specialist
  • Write SQL against relational databases to validate ETL processes and BI reports
  • Supports drug product and finish drug product annual review report sections
  • Draft quality procedures as needed to support newer business segment
  • Interpret and implement quality standards
  • Review and approval of protocols, work instructions and other functional testing documentation
  • Evaluate audit findings and drive to implement appropriate corrective actions
  • Assist in the completion of vendor audit questionnaires
  • Hosting and supporting customer (and regulatory) audits of the site
  • Acting as a point of contact for general queries relating to QA from customers and project teams
  • Supplier audits – determine, schedule and perform supplier audits
Qualifications for QA specialist / senior specialist
  • Able to mitigate unexpected change and be able to communicate impacts possible options to recover
  • Experience with automation (wrappers) SHELL or PERL scripting would be an asset
  • At least 6 years of experience with HP Performance Center
  • At least 2 years of experience with AWS automation
  • 6 years of experience with DNS
  • 6 years of experience with system resources measurement
3

QA Specialist / Senior Specialist Job Description

Job Description Example
Our company is looking to fill the role of QA specialist / senior specialist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for QA specialist / senior specialist
  • Actively identify, suggest and participate in continuous improvement activities
  • Draft, negotiate and complete quality agreements with customers and suppliers
  • Oversees the document control processes which include
  • Participates on clinical project teams, influences clinical teams toward a state of inspection readiness at all times
  • Plans, schedules, and conducts internal and external quality assurance audits of the systems, clinical investigative site audits, procedures, and controls employed in the design, conduct, and analysis of clinical trials
  • Assesses sponsor/investigator/monitor compliance with protocol, GCP and applicable regulatory requirements and relevant BSC policies and procedures
  • Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials
  • Participates in problem-solving with project teams at investigator sites
  • Communicates observations to clinical investigators and clinical program managers
  • Documents audit observations
Qualifications for QA specialist / senior specialist
  • 6 years UNIX experience with J2EE web hosted solutions
  • 6 years UNIX experience with .NET applications
  • 6 years of experience with performance test simulations or at least 6 years of experience in performance analysis or at least 6 years of experience in performance tuning or at least 6 years of experience in performance monitoring in a n-tier environment
  • Related experience should be in GMP-regulated industries in quality assurance and/or compliance or equivalent experience
  • Related experience in supporting an operational quality control lab
  • Bachelor’s degree in Chemistry, or related discipline (QA/RA), with at least 3 to 5 years relevant experience in pharmaceutical or related industry
4

QA Specialist / Senior Specialist Job Description

Job Description Example
Our company is searching for experienced candidates for the position of QA specialist / senior specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA specialist / senior specialist
  • Provide information/entrees for monthly/quarterly quality reports to management, review for trends and the timeliness of technical operations’ completion of quality processes
  • Ensures tracking of audit findings
  • Contributes to the development of audit procedures and processes
  • Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives
  • Keeps abreast of and interprets current worldwide regulatory requirements
  • Supports the CAPA process, working cooperatively with Clinical NCEP/CAPA owners providing quality input
  • May support clinical integration teams of acquisitions to ensure development and execution of a clinical integration plan, transfer of quality systems, and best practices in accordance with Quality project lead integration of quality system elements
  • Supports clinical teams in gathering and reporting various performance metrics for quarterly BU Management Review meetings
  • Plans, schedules, and conducts vendor audits
  • Communicate with global clinical teams and Strategic Sourcing regarding new clinical vendor requests, current clinical vendor needs, and future needs
Qualifications for QA specialist / senior specialist
  • Professional knowledge in GSP, GMP and GDP
  • Practical experience in SAP
  • Problem solving ability and skill
  • Ability to self learning
  • Review and approval of executed documents
  • Achieves quality assurance objectives by contributing information and analysis to strategic project plans and reviews
5

QA Specialist / Senior Specialist Job Description

Job Description Example
Our innovative and growing company is looking for a QA specialist / senior specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QA specialist / senior specialist
  • Assist team with identifying, creating, fleshing-out, and decompose requirements
  • Create, modify, and review contractually required technical documentation such as architectural documents, activity diagrams, entity-relationship diagrams, design documents
  • Maintain schedules and coordinate activities for project efforts while maintaining high quality execution
  • Collect, track and report test metrics and brief leadership on test status
  • Identify interdependencies, ambiguities or omissions
  • Evaluate the test automation strategy and approach to identify and recommend areas of improvement
  • Ensure successful coding and maintenance of automated unit tests
  • Debug test-automation failures and test-environment issues
  • Identify, troubleshoot and provide solutions for issues
  • Effectively manage test data
Qualifications for QA specialist / senior specialist
  • Participate to the Quality Compliance Scorecard (QCS) meetings (both locally and globally) as required
  • Be a CAPA Manager
  • Create all the necessary reports / metrics / KPI’s required by the Site and Global network
  • Manage Quality Projects as requested by Management and role
  • Job responsibilities will be primarily focused on North Reading (Massachusetts site) site with primary focus on warehouse operations
  • Bachelor’s degree in Life Sciences or Equivalent Experience

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