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Operational Quality Assurance Specialist Ii Jobs

Quality Specialist Ii Jobs
By Premera Blue Cross At United States
This is a virtual/remote position, working from home.
Conduct audits in a professional, ethical, and objective manner using and interpreting applicable standards/requirements.
Maintain in-depth working knowledge of procedural changes, audit techniques, and plan automated systems, subsystems, and reference materials for assigned audit functions.
Demonstrated skills in Microsoft Office Suite: Outlook, Access, Word, Excel, and PowerPoint.
Resolve conflict directly and respectfully, engaging in challenging and important conversations to resolve audit findings.
Identify trends and the root cause of errors and recommend improved procedures/guidelines to Operations proactively.
Quality Assurance Specialist Ii
By Adare Pharma Solutions At Ohio, United States
Experience using a Quality Management System; experience with Veeva preferred.
Work as part of the Quality Assurance team to meet company, departmental, and individual goals as outlined by management.
Knowledge and/or working experience of large processing systems, fluid air systems, and/or coacervation systems is highly preferred.
Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
Bachelor’s Degree preferred, with at least 4-6 years of Quality experience in a pharmaceutical or similarly regulated industry.
Knowledge in cGMP as related to records and documentation in a bulk pharmaceutical and solid oral dosage manufacturing environment is preferred.
Quality Assurance Area Specialist Ii
By Novo Nordisk At , West Lebanon
Releases product based on Quality Assurance record review and approval by Manager, Quality Assurance
Excellent written and verbal communication and negotiating skills are required
Strong planning and organization skills, with flexibility for changes in work priorities
Leading pay and annual performance bonus for all positions
34 Paid days off including vacation, sick days & company holidays
Health Insurance, Dental Insurance, Vision Insurance
Quality Assurance Analyst Ii
By Envision Healthcare At United States

Apply below: https://careers-evhc.icims.com/jobs/33446/quality-assurance-analyst-ii--embillz-billing/job?mode=view&mobile=false&width=1294&height=500&bga=true&needsRedirect=false ...

Quality Assurance Analyst Ii
By The Coca-Cola Company At , Atlanta, 30336
Process owners for specific areas / activities within the laboratory to ensure compliance to specific regulatory requirements
Perform out of specification investigations
Perform / Ensure material release in SAP
Assist customers to resolve material issues eg. block / unblock, SLE’s, STO’s
May perform method development and / or validation
Quality Assurance Specialist Ii
By Wacker Chemie AG At , San Diego, 92101
Experience with Electronic Document and Quality Management Systems preferred
Other essential responsibilities as assigned by management
Assisting in supporting the Quality Management System and other Quality duties.
Validation experience (Facility, Utilities Equipment or CSV) is a plus
Detail oriented and strong communication skills.
Critical thinking and problem-solving skills.
Sr. Quality Assurance Specialist Ii
By Resilience At , East Norriton $95,000 - $132,500 a year
Preferred Experience, Education & Qualifications
Working knowledge of GLP/GCP and GxP Regulatory requirements.
Demonstrated quality experience and the ability to collaborate with and effectively influence others.
Experience in preparation and participation in regulatory authority plant/site inspections.
7-10 years of relevant life sciences quality experience within quality and/or quality-related functions.
Experience with a quality batch review and batch release.
Quality Assurance Engineer Ii
By Motorola Solutions At , Plantation, 33322
Knowledge of quality management systems (like ISO, CMMI, etc.)
Excellent communication skills verbal and written
Experience in applying process improvement models (e.g. Digital Six Sigma, Lean, etc.)
Auditing certification: (e.g. ISO 9001 Internal Auditor Certification)
Bachelor’s Degree in Business, Finance, or Mechanical Engineering
Strong analytical, facilitation, documentation, and communication skills required.
Quality Specialist Ii Jobs
By Johnson & Johnson At , Athens
Provides input to management on quality and compliance. Ensures corrective actions implemented are effective.
A minimum of two (2) years of working knowledge and experience in a cGMP/highly regulated manufacturing environment.
Ability to apply risk management philosophy to business processes, decisions and data.
Must have proven skills to perform tasks accurately.
Must have skills to perform tasks without continuous supervision but seeking input as needed.
Strong troubleshooting skills to assist with defining problems, collection of data, establishment of facts and drawing valid conclusions.
Quality Systems Specialist Ii
By Pyros Pharmaceuticals At , Remote
In-depth knowledge of Regulatory/Compendial requirements, pharmaceutical quality, and Quality Systems, with broad experience and exposure to best practices is required.
Escalates potential risks to management during planning, review, data validation, data review, and archival processes.
Technical experience of working at a manufacturing facility with the ability to understand and interpret regulatory requirements is required.
Assists as needed with maintaining the supplier qualification process.
Experience with cGMP documentation is required.
Excellent oral/written communication, problem-solving/issue resolution, and prioritization skills required.
Quality Assurance Analyst Ii- Embillz Billing
By Envision Healthcare At , Conshohocken, 19428 $56,747 - $75,000 a year
Technical School Certification, Associate's Degree, or Bachelor's Degree required (or an equivalent combination of experience and education).
Write test cases based on information found in requirements and specifications, flowcharts, and process diagrams.
Diagnose problems, recommend solutions, and determine whether program requirements have been met.
Must have strong verbal and written communication skills.
Strong analytical skills are desired.
Specific knowledge of Emergency, Hospitalist, and Surgery RCM business is a plus.
Quality Assurance Specialist Ii, Validation
By Novavax, Inc. At , Gaithersburg, Md
Interface with system owners, IT, and facilities engineering to ensure all user and compliance requirements are tested.
Evaluate vendor qualification packages and create Novavax wrappers.
0-5 years of experience in Pharma or/and Biotech environment
At least 2 years of experience with any of the following: Facility, Laboratory or Manufacturing Equipment, Cleaning, and/or Process Validation
Excellent verbal and written communication skills.
Experience working on cross-functional teams.
Clinical Quality Specialist Ii
By Teladoc Health At United States
Experience with project management tools, spreadsheets, tracking deliverables and issues, meeting deadlines
Patient Safety/Risk Management experience preferred
Monitors for appropriate utilization, implements the policy, and communicates with all external stakeholders including clients, and account managers
Excellent written and verbal communication, and presentation skills
Ability to manage multiple projects simultaneously
5 years’ experience as an RN required, with at least 3 years in a Healthcare Quality role preferred.
Senior Quality Assurance Specialist Ii
By Takeda Pharmaceutical At , Lexington, Ma
BS with 10+ years relevant Quality experience
Strong relevant experience in executing, developing, and/or administrating GMP programs in cGMP biotech and/or pharmaceutical environments.
What Takeda can offer you:
Responsible for review of all criteria required for disposition of raw materials and products
Responsible for review of investigations and quality systems related to disposition of specific batches
Responsible for SAP transactions relevant to disposition
Quality Assurance Specialist Ii
By Iowa State University At , Ames, Ia
Intermediate-level position with solid professional and/or technical skills working under general supervision to achieve goals
Applies broad, working knowledge of the principles of the field to moderately complex, difficult, and varied problems and issues
Conducts internal quality controls to ensure established quality procedures and norms are followed.
Conducts technical and/or complex quality analysis and tests of a quality control program.
Recommends necessary quality procedure changes.
Monitors and records inconsistencies with quality procedures and norms.
Quality Assurance Specialist Ii - Homebased
By ICON Strategic Solutions At United States
Manage process for vigilance assessments to ensure on time completion and escalation if required.
Manage process for clinical complaints to ensure all steps completed in a timely manner.
5 years’ experience in pharmaceutical industry
3 years of documented Quality Control experience in pharmaceutical
Track and trend all globally reportable complaints including initial, follow up and final reports.
Liaise with compliance team (for all reports) and EU Authorised Rep (for EU reports) to ensure submission of all reports.
Quality Assurance Operational Specialist - Weekend Shift
By GSK At Marietta, PA, United States
Project Management experience a plus
Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
Write and/or revise controlled documents in support of job responsibilities.
Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.
Packaging Operations experience a plus
Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
Quality Assurance Engineer Ii
By Konami Gaming, Inc. At Las Vegas, NV, United States
Working knowledge of Database Management Systems, preferably Oracle or SQL.
Bachelors Degree in applied science or related field, or higher degree, or equivalent combination of education and experience.
3+ Years Software Quality Assurance/Gaming Experience or combination of education and experience.
Skilled in data query and analysis to uncover and identify software anomalies.
Develop and execute test cases and test scripts to ensure compliance with design requirements and gaming regulations.
Setup test system configurations to meet testing requirements.
Quality Assurance Engineer Ii
By Polaris Pharmaceuticals Inc. At Vacaville, CA, United States
Act as Project Quality Manager and implement the Requirements of the Quality Management System on assigned projects.
Responsible for supporting improvement of supplier quality management of multiple manufacturing sites.
Assist with management and development of assigned Quality Engineers.
Knowledge of and experience with bug tracking systems.
Review project specific procedures and documents to verify that they comply with the contractual requirements.
Or modify and execute tests based on manual test cases, functional requirements or existing functionality of the system for product/project releases.
Associate Ii, Quality Assurance
By American Red Cross At Nashville, TN, United States
Review, assess and monitor records, processes, and systems at the critical control points in the process.
Monitor the implementation and effectiveness of corrective actions.
Stop the manufacturing, testing and distribution of products and services if the process or product is compromised and take appropriate action.
Participate in meetings for review of quality concerns. May represent department on projects, work groups, and process improvement teams.
Identify and participate in process improvement and standardization activities and monitor change for effectiveness.
Health Spending Accounts & Flexible Spending Accounts

Are you looking for an exciting opportunity to join a dynamic team as an Operational Quality Assurance Specialist II? We are looking for a highly motivated individual who is passionate about quality assurance and has a keen eye for detail. As a member of our team, you will be responsible for ensuring that our products and services meet the highest standards of quality. You will also be responsible for developing and implementing quality assurance processes and procedures, as well as monitoring and reporting on quality assurance performance. If you are looking for a rewarding career in quality assurance, then this is the perfect job for you!

Overview Operational Quality Assurance Specialist II is responsible for ensuring the quality of products and services provided by the organization. They are responsible for developing and implementing quality assurance processes and procedures, monitoring quality performance, and providing feedback to management. They also investigate customer complaints and take corrective action when necessary. Detailed Job Description Operational Quality Assurance Specialist II is responsible for developing and implementing quality assurance processes and procedures to ensure the quality of products and services provided by the organization. They are responsible for monitoring quality performance, providing feedback to management, and investigating customer complaints. They also take corrective action when necessary. Job Skills Required
• Knowledge of quality assurance principles and practices
• Knowledge of quality control methods and techniques
• Ability to analyze data and identify trends
• Ability to develop and implement quality assurance processes and procedures
• Ability to monitor quality performance
• Ability to provide feedback to management
• Ability to investigate customer complaints
• Ability to take corrective action when necessary
• Excellent communication and interpersonal skills
• Excellent problem-solving and decision-making skills
• Excellent organizational and time management skills
Job Qualifications
• Bachelor’s degree in Quality Assurance, Quality Control, or related field
• At least 5 years of experience in quality assurance
• Certification in Quality Assurance (e.g. ASQ CQA) is preferred
Job Knowledge
• Knowledge of quality assurance principles and practices
• Knowledge of quality control methods and techniques
• Knowledge of data analysis and trend identification
Job Experience
• At least 5 years of experience in quality assurance
Job Responsibilities
• Develop and implement quality assurance processes and procedures
• Monitor quality performance
• Provide feedback to management
• Investigate customer complaints
• Take corrective action when necessary