Senior Quality Specialist Job Description

Senior Quality Specialist Job Description

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Senior quality specialist provides advice and guidance on interpretations of regulatory requirements, testing standards and methods, and SOPs.

Senior Quality Specialist Duties & Responsibilities

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

Sample responsibilities for this position include:

Advises the individuals responsible for managing the Quality Issues by facilitating root cause analysis and advising on corrective and preventive action plans, per Company Standard Operating Procedures and associated standards
Ensures in collaboration with business partners that Policies and SOPs in the controlled document landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations
Write and review GMP documentation (SOPs, protocols, technical reports, specifications)
Reviews “potential” Quality Issues that are reported by individuals across the Company and determines whether the Quality Issues meet the Company’s definition of “Quality Issues”
Based on the initial information provided, determines the level of criticality of the Quality Issues in accordance with Company requirements
Reviews a subset of the “critical” reported Quality Issues
Identifies whether the Quality Issues are reportable to any regulatory authority
Manages, prepares for, and leads internal GMP audits
Serves as Subject Matter Expert for internal matters
Manages, prepares for, performs, and leads supplier audits

Senior Quality Specialist Qualifications

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

Licensing or Certifications for Senior Quality Specialist

List any licenses or certifications required by the position: ASQ, ISO, CQE, PMP, ITIL, SWPPP, TSE/BSE, CQA, GMP, QA

Education for Senior Quality Specialist

Typically a job would require a certain level of education.

Employers hiring for the senior quality specialist 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 Senior Quality Specialist

Desired skills for senior quality specialist include:

XML
Handling Unix/Linux environment
SOPs
Main certification methods
Standards
Accreditation standards and quality improvement processes
Applicable regulatory requirements
At least one SAP module so that can help the team perform the functional correctness testing
CRO
CSS

Desired experience for senior quality specialist includes:

Position requires fundamental computer skills including use of all Microsoft Office applications
No Written Warnings for performance within past year
Minimum performance rating of Meets – High Meets preferred
Recommendation from current Supervisor or Site Manager
Recognized ability to read, analyze, and execute upon written documents and approved procedures
Ability to deliver feedback in a professional manner

Senior Quality Specialist Examples

1

Senior Quality Specialist Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of senior quality specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for senior quality specialist
  • Write, review and complete SOPs in the Logistics QMS
  • Monitors use of system to ensure document standards are maintained
  • Monitors use of local document management system and interfaces to ensure document standards are maintained within Global Logistics
  • Review Red Flag Wires and recommend release of daily high-risk wires or rejection of fraudulent wires
  • Upon request, provide unit managers accurate quality assurance status that identifies operational deficiencies
  • Oversees and administers SOP, document and records management system, the deviation, change control, complaint handling, training and CAPA systems at the site
  • Conducts vendor/supplier audits
  • Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities
  • Provide Quality support to site projects, cGMP systems, and new products
  • Under general supervision, facilitate the QA Department’s daily activities with emphasis on cGMP
Qualifications for senior quality specialist
  • Minimum of 6-8 years experience as a Quality Assurance Manager with a pharmaceutical company
  • Extensive experience in Quality Assurance, Quality Management or Process Improvement in a clinical research environment
  • Emerging leadership and mentoring experience required
  • Physical Demands / Surroundings - Must be able to enter the production, laboratory, and utility areas, which requires gowning and the use of stairs
  • Previous GMP experience
  • Deliver results across diverse areas at Site
2

Senior Quality Specialist Job Description

Job Description Example
Our innovative and growing company is hiring for a senior quality specialist. 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 senior quality specialist
  • Development of Complaint Closure Letters as required
  • Lead and manage all operational quality related issues and
  • Provides Specialized Audit Quality Support.Supports team supervisors in reliably completing client requests, data management needs, and overpayment record review
  • Generates and Analyzes Quality Audit Reports.Provides support to supervisors to review and complete supplier quality audit reports initiated by the client
  • Supports Process Improvement.Continuously analyzes processes and systems used during the course of work to identify internal areas of improvement and proactively communicates feedback to supervisors
  • Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done
  • Establishes regional requirements for the EPD Training Quality System
  • Adopt and implement the Global/ Regional Quality Management Plan within the scope of the assignment
  • Revise any other quality documentation, such as protocols, manuals, quality agreements, as required
  • User maintenance and management of qualification status
Qualifications for senior quality specialist
  • Knowledge of OHS is big advantage
  • Responsible and proactive self-drive person
  • Maintain productive and cooperative relationship with partners and contract manufacturing, test organizations, and other contract service providers as required
  • HS Diploma AND a minimum 8 years relevant experience or a combination of equivalent education and relevant experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations
  • BS Degree in Quality Engineering, Supply Chain or related discipline is preferred
  • Five to seven years’ experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations
3

Senior Quality Specialist Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of senior quality specialist. 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 senior quality specialist
  • Provide Quality validation review & approval through the preparation, execution, data analysis, & report writing for IQ, OQ & PQ protocols
  • Quality review & approval of Change Requests (CR’s) related to project validation & other validation activities for the site
  • Perform compliance & technical reviews/approvals of protocols & protocol data
  • Review & approve validation failure investigations & non-conformities utilizing root cause analysis techniques
  • Review & approve specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes & the validation
  • Identify process improvements before equipment, systems or processes are placed under change control during validation
  • Manage and complete each assigned Annual Product Review (APR)
  • Communicate validation issues and requirements to plant personnel on a frequent basis through participation in Engineering, R&D and management staff meetings, applicable project teams
  • Track all validation documentation throughout the plant and follow-up as needed
  • Perform other quality functions as necessary or as requested
Qualifications for senior quality specialist
  • SuccessFactorscareer201609
  • Experience with testing on Mobile devices is a plus
  • Bachelor of Science degree ( BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering or equivalent)
  • The qualified candidate will have in depth knowledge of cGMP regulations for the pharmaceutical industry, specifically FDA and/or EMA
  • Bachelor’s degree in biological sciences, toxicology, or a related field
  • Detail oriented with Quality Assurance background and solid problem-solving skills
4

Senior Quality Specialist Job Description

Job Description Example
Our growing company is looking to fill the role of senior quality specialist. 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 senior quality specialist
  • Review results with local management
  • Acts a back up to Manager, Quality Assurance/Privacy Lead
  • Provide support and assistance to all Quality/Privacy and Compliance Specialists
  • Complete CAPA and Deviation investigation in collaboration with the BU
  • Performs Quality risk assessment of all Change Controls on behalf of Manager
  • Coordinates, plan and executes scheduled audits audits of programs, departments and systems within the Pharmaceutical Solutions business in accordance with applicable Standard Operating Procedure(s) and work instructions
  • Manages Product Quality Complaints, Recalls and Quality Holds for all Wholesale activities
  • Investigates all temperature excursions for storage of Specialty Drugs at all INVIVA clinics
  • Provides MasterContol Quality System support to BU
  • Assists in maintaining the quality systems
Qualifications for senior quality specialist
  • Knowledge and experience with Medical Device regulations
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends
  • Fluent (spoken and written) in a Scandinavian language English
  • Quality Assurance experience with batch chemical API processes and products
  • 2 years experience as a QA in a BPO company
  • Experience with travel accounts is a plus
5

Senior Quality Specialist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of senior quality 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 senior quality specialist
  • Work with teams (internal and external) to collect necessary information to ensure the Mobile product delivered is of high quality
  • Work with the team to create automation test suite for build validation in a continuous delivery
  • Reviews both financial and non-financial inforce transactions of moderate complexity that have been completed for file and are pending for quality review in AWF using systems such as SSF, RUMBA, and/or Cyberlife
  • Reviews inforce transactions, to ensure it is processed in accordance to company stated guidelines, procedures, and the customer’s request
  • Informs the processing representative and applicable manager of errors and provides feedback and/or procedures on how to correct the item, if an item is processed incorrectly or missing requirements
  • Maintains a strong working knowledge of administrative systems, products, and procedures by regularly reviewing procedural updates, seeking continued education, and collaboration with peers and business partners
  • Participates in special projects as assigned by the Experience Improvements Manager, such as working on cross-departmental teams to identify and implement process improvements
  • Providing guidance on medical device design controls requirements to product development teams and cross functional team members
  • Contribute towards the development of retrospective and prospective Design History Files
  • Support development of Device Risk Management as needed
Qualifications for senior quality specialist
  • Ability to successfully communicate within all levels of management
  • Minimum of five (5) years experience with B.S
  • Previous experience in quality control/quality assurance
  • Strong clinical/technical acumen
  • Strong multi-task & situational management
  • Must be capable of interfacing with senior level health care executives and be able to resolve complex customer service issues

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