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Gxp Qa Specialist Jobs

Qa Specialist Jobs
By RTO National At Greenville, SC, United States

Job Title: Quality Assurance Specialist Reports to: QA Manager Department: OPS Date Updated: June 2023 Objective The Quality Assurance Specialist will be highly motivated and detail-oriented for our ...

Qa Field Specialist Jobs
By Aequor Information Technologies Pvt. Ltd. At Summit, NJ, United States
Must have knowledge and Quality experience with cGMP manufacturing US and global requirements.
Required Competencies: Knowledge, Skills, And Abilities:
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy.
Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
Supports Risk Assessments/projects as required by senior management.
Qms/ Qa Specialist Jobs
By Steri-Tek At Lewisville, TX, United States
Complete continuing education requirements described during performance review
Complete any task assigned by the Quality Manager
Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002
Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs
Manage due dates and implementation dates for QMS programs
High School Diploma or equivalent experience
Specialist Qa Jobs
By The Hershey Company At , Hershey
Strong computer, document management skills and attention to detail
Minimum Education and Experience Requirements:
Facilitates production activities to meet quality/safety specifications and regulatory standards by providing training, auditing, troubleshooting and incident management.
Provide Plant wide leadership, project management, training, and coaching, in the specified areas of expertise.
Coordination of activities: Plant management level and below/corporate teams/external contacts.
Proficiency in computer programs/software such as Microsoft Word, Outlook, Excel, Access, Power Point, SAP (Recipe Management), Net Weight and Trackwise
Qa Specialist I Jobs
By AbbVie At Dublin, CA, United States
Proficiency in MS Office suite and database management, and preferably experienced with SAP S/4 HANA and Power BI.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
Minimum of 2 years of medical device quality or equivalent experience in FDA regulated medical device manufacturing environment(s).
Knowledge of QSR and ISO 13485.
Excellent communication skills, both written and verbal
Develop quality plans for site projects
Qa Specialist Ii Jobs
By Gilead Sciences At San Dimas, CA, United States
QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
Demonstrates audit and investigation skills, and report writing skills.
Demonstrates strong verbal, technical writing and interpersonal skills.
Prior experience in pharmaceutical industry is beneficial.
Qa & Content Specialist Jobs
By Nebo Agency At , Atlanta, 30310
Knowledge and experience working with a creative team, from research through to development and QA
We’re a human-centered agency, focusing on and building rewarding digital experiences
Nebo is proudly born and bred in ATL, but remote-hybrid.
Experience with the “behind the scenes” CMS roles
Communication skills to solicit feedback and resolve content or structure issues collaboratively and proactively
We’re an independently owned agency, not part of some big holding company.
Website Qa Specialist Jobs
By Beasley Media Group, Inc. At , Charlotte, 28203
Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
Execute test plans, document defects, and report results to management
Ensure all requirements are testable and covered in test cases
Ensure all issues are communicated and test risks are managed
Bachelor’s degree in computer science, Information Technology, or a related field (or equivalent work experience).
Proven experience in a similar role, providing technical support for web services and troubleshooting website issues.
Operations Training Specialist - Qa
By Stanford Health Care At , Newark, 94560 $33.45 - $37.68 an hour
Three (3) years of progressively responsible and directly related work experience in a healthcare setting, preferably in a call center environment
Strong written and verbal communication skills, customer service, interpersonal skills and cross-cultural competency.
Knowledge of basic medical terminology
SHC Commitment to Providing an Exceptional Patient & Family Experience
You will do this by executing against our three experience pillars, from the patient and family’s perspective:
Expertise of 2 or more specialized functions and primary resource for at least two of the specialized functions
Qa Specialist Iii/Iv
By AstraZeneca At , Frederick, 21703
Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to their functional area.
Writes new standard operating procedures or revises existing documentation utilizing document management systems
Creates/revises QA documents (SOPs, technical reports, risk assessments) in document management system
Creates and manages deviations, change controls, and CAPA records pertaining to their functional areas in VEEVA EQV
Good knowledge of industry regulations and standards.
5+ yrs of industry experience
Agile Qa Specialist Jobs
By Tri-Force Consulting Services At , Richmond, 23219
Required 5 Years of Software QA Testing experience
Required 3 Years of Agile Development / QA Testing experience
Required 2 Years of GitLab experience
Required 2 Years of HP / Microfocus Quality Center experience
Required 5 Years of Business Analysis experience
Develop and implement automated testing scripts
Qa Specialist Non-Conformance/Capa
By Astellas At , Sanford
Experience managing and improving Quality Management Systems and metrics
Experience with Quality Management Systems (Veeva, TrackWise, Veeva Quality Docs, etc.)
Perform other support responsibilities as requested to support Quality and Compliance 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)
Qa Specialist Jobs
By Element Materials Technology At , Santa Rosa, 95403
Acting as a designee of QA Manager
Review of executed batch records, validation, qualification, stability protocols and reports
Ensuring that internal audit requirements are met
Strong oral and written communication skills
Maintaining SOP system development and revision program under the supervision of Director of QO/QA
Assisting in all QA operations
Regional Qa Specialist Jobs
By RadNet At New York City Metropolitan Area, United States
Minimum Qualifications, Education and Experience
Consistently adheres to the time management policies and procedures.
Runs policy acknowledgement reports and follows-up with managers and medical directors who have outstanding employees.
Assists new managers and new site specific QA Coordinators with QA Tracker data entry.
Practices good communication skills; comprehends and initiates written and verbal instructions when appropriate.
Completes job responsibilities in a quality and timely manner.
Healthcare Qa Specialist Jobs
By Trinity IT Services At United States
Organizes documents for management review, software release, and audits
Provides support to the supplier management process
Manages and documents the medical device complaint process; delegates issues to the appropriate parties for investigation and resolution
Working knowledge of FDA and international medical device regulations
Skill in Microsoft Office applications
Creates and monitors reports for departmental key performance indicators
Qa Specialist Jobs
By Fresenius Kabi At , Melrose Park, 60160
Experience with Documentum Electronic Document Management System (EDMS) is required.
Knowledge of SAP / Quality Management module.
Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.
Works with the IT Support Team to ensure cGMP/quality data is managed according to Documentum functions.
Working knowledge of GMPs and related Quality System processes is required.
Position requires individual with high degree of accuracy. Must be able to translate theoretical knowledge into practical application.
Specialist, Qa Disposition Jobs
By Bristol Myers Squibb At , Township Of Warren
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Equivalent combination of education and experience acceptable.
Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.
Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
Able to recognize conflict and notify management with proposed recommendations for resolution.
Qa Specialist Jobs
By ARC-One Solutions At , Miramar, 33023, Fl
Organizes documents for management review, software release, and audits
Provides support to the supplier management process
Manages the medical device complaint process including documentation and fielding of issues to the appropriate parties for investigation and resolution
Experience in external inspections by regulatory bodies
Skill in Microsoft Office applications.
Creates and monitors reports for departmental key performance indicators, tracks and trends
Senior Qa Specialist Jobs
By Neuralink At , Fremont, Ca $95,026 - $124,200 a year
Performs ongoing compliance audits using standard evaluation tools for audit/monitoring activities and ensures adherence to regulatory requirements.
Assists with monitoring activities involving the effective execution of corrective action requirements.
4+ years of experience in clinical quality assurance or related roles.
Proficient in Good Clinical Practice (GCP) guidelines and regulatory requirements.
Strong quality assurance and analytical skills.
Excellent communication and collaboration abilities.
Qa Specialist I Jobs
By uniQure At , Lexington, 02421, Ma
Support the continuous improvement and oversight of Quality Management System procedures.
1-3 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Experience working in a GMP manufacturing environment
Ability to manage multiple activities with challenging timelines
Review and approve batch records and solution lot records.
Support internal and external audits.