Senior Quality Specialist Job Description
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:
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:
Desired experience for senior quality specialist includes:
Senior Quality Specialist Examples
Senior Quality Specialist Job Description
- 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
- 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
Senior Quality Specialist Job Description
- 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
- 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
Senior Quality Specialist Job Description
- 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
- 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
Senior Quality Specialist Job Description
- 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
- 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
Senior Quality Specialist Job Description
- 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
- 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