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Quality Assurance Compliance Specialist Jobs

Specialist, Quality Interventions/Qi Compliance (Remote In Nebraska)
By Molina Healthcare At Nebraska, United States
Actual compensation may vary from posting based on geographic location, work experience, education and/or skill level.
Min. 3 years’ experience in healthcare with 1 year experience in health plan quality improvement, managed care, or equivalent experience.
Operational knowledge and experience with Excel and Visio (flow chart equivalent).
Creates, manages, and/or compiles the required documentation to maintain critical quality improvement functions.
Surfaces to Manager and Director any gaps in processes that may require remediation.
Demonstrated solid business writing experience.
Quality Assurance Specialist Iv, Supplier Quality And Compliance
By Novavax, Inc. At , Gaithersburg
Execute supplier complaint process with routine reports to management, assess supplier’s qualification status and communicate potential risks.
Serve as subject matter expert for supplier management during audits and regulatory inspections.
Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 10+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
Manage the day-to-day activities and operations of the Corporate Audit and Supplier Quality Programs.
8+ years of quality systems experience in a Quality organization
Research Compliance Quality Assurance Coordinator
By Texas Christian University At , Fort Worth, 76109
2 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).
3 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).
2 years’ experience in a role requiring strong coordination skills; e.g., organization, communication, analysis (experience can run concurrently).
Knowledge of QA principles and theories.
Ability to apply leadership skills, assume responsibility and function under minimum supervision.
Work may require walking across campus or commuting to medical school site to conduct audits or provide education.
Director, Quality Assurance - Facilities And Compliance
By KBI Biopharma At , Durham $165,000 - $195,000 a year
In conjunction with the Engineering, Validation and IT teams, develop and manage all qualification and validation policies, procedures, and protocols.
Basic math skills are required. Ability to apply concepts of basic algebra and statistics.
Sitting for long periods of time at a computer. Push and pull up to 30 lbs.
Salary Range: $165,000 - $195,000
Quality Assurance Specialist Iii, Laboratory Compliance
By Novavax, Inc. At , Gaithersburg
Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
Extensive experience in laboratory controls including analytical method validation, routine and stability testing, investigations, and change controls.
Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax
Capable to manage multiple priorities, adapt and maintain adherence to timelines
Demonstrated ability to manage process improvement projects
Demonstrated knowledge of GMP, GLP, GCP and GCLP expectations
Sr. Specialist, Safety Quality & Compliance - Remote
By Emergent Biosolutions At ,
Strong project management and organization skills
Manage and coordinate Pharmacovigilance department SOP revision process
Excellent overall communication skills with demonstrated written and verbal communication skills
Assist with Pharmacovigilance audit and inspection activities
Collate KPI information for routine reviews
Collaborate with Pharmacovigilance team members to complete QMS elements such as deviations, change controls and CAPAs
Specialist, Quality Systems & Compliance
By Astellas At , Sanford
The Specialist, QA Systems and Compliance will report to the Sr. Manager, Quality Systems and Compliance
Executes supplier audits and implements Astellas requirements where applicable.
Perform other support responsibilities as requested to support Quality and Regulatory oversight activities.
Proven ability to manage multiple projects while maintaining quality
Strong interpersonal skills with reputation for collaboration with colleagues
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
Senior Compliance Associate -Quality Assurance
By KeyBank At , Remote $85,000 - $92,000 a year
Excellent writing skills and the ability to succinctly convey information to senior business and compliance management.
Keeping management apprised and recognizing when to escalate issues as needed.
At least 3 – 5 years of BSA/AML banking compliance or regulatory experience.
Experience working with FFIEC Exam Manual high risk customer types, including conducting CIP, KYC, and CDD / EDD.
Experience with transaction monitoring and case investigations, including Suspicious Activity Report filing.
CAMS and/or ACFCS certification desired.
Quality Assurance Compliance Specialist Iii
By Novavax, Inc. At , Gaithersburg, Md
Execute supplier complaint process with routine reports to management, assesses supplier’s qualification status and communicates potential risks.
Serve as lead corporate and supplier auditor and Supplier Quality Programs minimal guidance from management.
Serve as subject matter expert for supplier management during audits and regulatory inspections.
Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
6+ years of quality systems experience in a Quality organization
Manager Global Sourcing And Compliance - Quality Assurance
By Floor & Decor At Atlanta, GA, United States
Knowledge of supplier qualification processes and supplier performance metrics preferred
Minimum 5 years of relevant experience (preferably in retail)
Supplier Quality background and experience preferred
Knowledge of integrated ERP systems and world-class supply chain practices preferred
Possess good process experience, judgment and the ability to recognize key problems
Excellent communication skills (verbal and written)
Director Of Compliance / Quality Assurance -Healthcare
By Source EQ At San Francisco, CA, United States
Demonstrated successful experience as a Quality Assurance Director or equivalent in a nonprofit, government, or other clinical setting
Demonstrated planning and organizational skills
Superb written and oral communication skills
Hybrid work model - 3 days from home
Conduct and ensure compliance with all contractual, regulatory, and ethical obligations of the agency
Lead preparation and execution of all external and internal program audit activities (CARF, County, Medi-cal etc)
Specialist, Quality Interventions/Qi Compliance (Remote In Va) ($45390.00 - $88511.00 / Year)
By Talentify.io At United States
Actual compensation may vary from posting based on geographic location, work experience, education, and/or skill level.
Monitor and ensure timely and accurate completion of key quality activities, presenting results to management and other departments
Bachelor's Degree or equivalent combination of education and work experience
Minimum 3 years' experience in healthcare with 1 year experience in health plan quality improvement or managed care
Operational knowledge and experience with Excel and Visio
Competitive benefits and compensation package
Quality Assurance Compliance Specialist
By Synectics Inc. At Indianapolis, IN, United States
Leads the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators, as appropriate.
Works with the management team to implement and execute the Inspection Readiness program; including Corporate Inspections and Global Health Authority Inspections.
Contributes significantly to the site inspection preparation, program management, response and commitment process.
Adheres to all GMP requirements.
Supports the development and oversight of robust quality systems, including both implementation and operation at site level.
Facilitates training on all QA Compliance programs.
Compliance Quality Specialist - Remote
By Intoxalock At United States
Assist with updating reports, data entry and required documentation.
1+ years of experience in general office administration.
A comprehensive and highly competitive benefits package
Work from home and still be part of a team!
Professionally handle and direct all phone interactions in a timely and courteous manner.
Respond to emails, chats, and texts in a timely manner in accordance with department SLAs within the CST Organization.
Quality & Compliance Specialist I
By Polaris Pharmaceuticals Inc. At Vacaville, CA, United States
Experience with risk management facilitation is required.
Assist/conduct training for risk management, investigations, change controls, auditing, supplier management programs, and other processes as needed.
Formal Risk Management training is recommended.
Conduct audits of suppliers to ensure they comply with their procedures, regulations, and Polaris Pharmaceuticals, Inc. requirements.
Develop familiarity and keep current with cGMP and applicable regulatory requirements as needed.
Excellent written, verbal, and communication skills.
Manager, Compliance & Quality Assurance
By DAOU At Paso Robles, CA, United States
1–2 years’ experience in the principles and practices of compliance, quality management, and quality assurance, preferably in the wine industry.
Strong self-management skills, with the added ability to take initiative, multi-task, be innovative and work under pressure.
Perform daily and weekly wine lot data entry tracking and traceability; ensure software transactions are performed accurately and timely.
Perform data entry audits by wine tiers to ensure accuracy and completeness. 
Be well-versed and knowledgeable in federal and state regulations for wine and spirits.
Certification for quality control (such as ISO 9000) is a plus.
Specialist, Quality Systems And Compliance
By Moderna At Norwood, MA, United States
Support Quality Management Review, Annual Product Review, Deviation Review Board, Change Review Board and CAPA review board initiatives.
BA/BS degree (preferred) with at least 2 years of Quality Assurance working experience in pharmaceutical industry providing Quality Assurance oversight.
Demonstrated data analysis and analytical tool experience.
Family care benefits, including subsidized back-up care options and on-demand tutoring
Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Quality Assurance Compliance Specialist
By Piramal Pharma Solutions At Riverview, MI, United States
Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP systems.
Risk Management: Participate in the Risk Management program, including updating risk analysis, participating in applicable teams and maintaining Risk Management documents.
Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance.
Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
Quality Assurance Compliance Specialist
By Synectics Inc. At United States
Supplier Management and Quality/Compliance experience required.
Knowledge of document management is ideal
Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.
Experience in SCAR and or CAPA.
At least 2 years of experience in a Quality field
Knowledge of documentation processes GMP
Senior Specialist, Quality Compliance
By Edwards Lifesciences At United States
Demonstrates professional communication and interpersonal relationship skills including consultative approaches and relationship management
Manage customer relationship and expectations during course of complaint investigation and resolution process
Bachelor's Degree in related field, plus minimum of 5 years relative experience complaint handling or quality compliance required
Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), or related regulated environment required
Advanced knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing

Are you looking for an exciting opportunity to join a fast-growing company and help ensure quality assurance and compliance? We are looking for a Quality Assurance and Compliance Specialist to join our team and help ensure our products and services meet the highest standards of quality and compliance. You will be responsible for developing and implementing quality assurance and compliance processes, monitoring and auditing quality and compliance, and providing feedback and recommendations to management. If you have a passion for quality assurance and compliance and are looking for a challenging and rewarding role, then this is the job for you!

An Quality Assurance And Compliance Specialist is responsible for ensuring that a company’s products and services meet the standards set by the company and by applicable regulations. They are responsible for developing and implementing quality assurance and compliance policies and procedures, and for monitoring and auditing the company’s processes and products to ensure that they are in compliance. They also provide guidance and training to staff on quality assurance and compliance matters. To become an Quality Assurance And Compliance Specialist, you will need a bachelor’s degree in a related field such as engineering, quality assurance, or business. You may also need to have experience in a related field such as quality assurance, auditing, or regulatory compliance.

Quality Assurance And Compliance Specialist skills required for your resume and career include:

• Knowledge of quality assurance and compliance principles and practices
• Knowledge of applicable regulations and standards
• Ability to develop and implement quality assurance and compliance policies and procedures
• Ability to monitor and audit processes and products
• Ability to provide guidance and training to staff
• Excellent communication and interpersonal skills
• Strong organizational and problem-solving skills
• Attention to detail
• Ability to work independently and as part of a team

Quality Assurance And Compliance Specialist knowledge for your resume and career include:

• Quality assurance and compliance principles and practices
• Applicable regulations and standards
• Quality assurance and compliance policies and procedures
• Auditing and monitoring processes and products
• Regulatory compliance
• Risk management
• Data analysis
• Process improvement

Quality Assurance And Compliance Specialist responsibilities for your resume and career include:

• Developing and implementing quality assurance and compliance policies and procedures
• Monitoring and auditing processes and products to ensure compliance
• Providing guidance and training to staff on quality assurance and compliance matters
• Investigating and resolving quality assurance and compliance issues
• Maintaining records and preparing reports
• Identifying areas for improvement and recommending solutions
• Working with other departments to ensure compliance

Quality Assurance And Compliance Specialist experience for your resume and career include:

• Previous experience in a related field such as quality assurance, auditing, or regulatory compliance
• Experience in developing and implementing quality assurance and compliance policies and procedures
• Experience in monitoring and auditing processes and products
• Experience in providing guidance and training to staff
• Experience in investigating and resolving quality assurance and compliance issues

Quality Assurance And Compliance Specialist qualifications for your resume and career include:

• Bachelor’s degree in a related field such as engineering, quality assurance, or business
• Professional certification in quality assurance or compliance
• Knowledge of applicable regulations and standards
• Excellent communication and interpersonal skills
• Strong organizational and problem-solving skills
• Attention to detail

Quality Assurance And Compliance Specialist educations for your resume and career include:

• Bachelor’s degree in a related field such as engineering, quality assurance, or business
• Professional certification in quality assurance or compliance
• Courses in quality assurance and compliance principles and practices
• Courses in applicable regulations and standards
• Courses in auditing and monitoring processes and products
• Courses in risk management and data analysis

Tools that help Quality Assurance And Compliance Specialists work better include:

• Quality assurance and compliance software
• Auditing and monitoring tools
• Risk management software
• Data analysis software
• Process improvement software

Good tips to help Quality Assurance And Compliance Specialists do more effectively include:

• Stay up to date on applicable regulations and standards
• Develop and implement quality assurance and compliance policies and procedures
• Monitor and audit processes and products regularly
• Provide guidance and training to staff on quality assurance and compliance matters
• Investigate and resolve quality assurance and compliance issues promptly
• Maintain records and prepare reports
• Identify areas for improvement and recommend solutions

Common Quality Assurance And Compliance Specialist interview questions include:

• What experience do you have in developing and implementing quality assurance and compliance policies and procedures?
• How do you ensure that processes and products are in compliance with applicable regulations and standards?
• What experience do you have in providing guidance and training to staff on quality assurance and compliance matters?
• How do you investigate and resolve quality assurance and compliance issues?
• What tools do you use to monitor and audit processes and products?
• How do you identify areas for improvement and recommend solutions?