CrawlJobs Logo

Regulatory and Quality Operations specialist

https://www.roberthalf.com Logo

Robert Half

Location Icon

Location:
United States , Elgin

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

We are seeking an experienced Regulatory and Quality Operations specialist to join our team in Elgin, Illinois. In this role, you will play a pivotal part in managing product lifecycles, ensuring regulatory compliance, and aligning customer specifications with industry standards. This is a long-term contract position, offering the opportunity to contribute to quality assurance and supply chain operations within a dynamic environment.

Job Responsibility:

  • Develop and maintain product specifications and verification documents in alignment with quality standards
  • Collaborate directly with customers to ensure their specifications meet regulatory compliance and industry requirements
  • Manage the complete product lifecycle, ensuring alignment with both customer needs and regulatory guidelines
  • Conduct audits and reviews to maintain adherence to regulatory and quality assurance standards
  • Oversee nutritional labeling processes to ensure compliance with legal and industry-specific requirements
  • Prepare and manage regulatory documents to support customer and internal operations
  • Implement quality assurance processes to uphold consistent standards across supply chain activities
  • Coordinate with vendors and stakeholders to resolve account discrepancies and streamline invoice management
  • Monitor supply chain operations to ensure effective management and alignment with organizational goals
  • Identify opportunities for improvement in quality and regulatory operations, driving continuous enhancement

Requirements:

  • Proven experience in regulatory compliance, quality assurance, and supply chain management
  • Familiarity with nutritional labeling requirements and industry standards
  • Skilled in creating and verifying product specifications and related documentation
  • Ability to manage and oversee product lifecycles effectively
  • Strong knowledge of regulatory audits, quality audits, and assurance processes
  • Proficiency in resolving account discrepancies and managing vendor invoices
  • Excellent communication and customer collaboration skills to align specifications with compliance needs
  • Detail-oriented with the ability to ensure accuracy in regulatory and quality documentation
What we offer:
  • medical, vision, dental, and life and disability insurance
  • eligible to enroll in our company 401(k) plan

Additional Information:

Job Posted:
January 25, 2026

Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Regulatory and Quality Operations specialist

Operations Specialist I

The Operations Specialist I will play a key role in assisting the Operations Man...
Location
Location
United States , Scottsdale
Salary
Salary:
64000.00 - 88000.00 USD / Year
clearwayenergy.com Logo
Clearway Energy
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Ability to coordinate multiple activities and ensure safety, quality, and schedule adherence
  • Two years’ experience in Operations or a Solar and Wind Field Technician Role is preferred
  • Able to demonstrate competent technical knowledge of plant and system processes and experience in operating electrical and SCADA systems
  • Ability to take direction, identify problems, develop solutions, conduct analysis independently and in collaboration with others
  • Ability to work in difficult customer situations and show strong verbal and written communication skills
  • Ability to work in a high-stress environment where decisions directly impact personnel safety and equipment reliability
  • Ability to work rotating shifts of 12.5 hours, including nights, weekends, and holidays
  • Available for 24-hour on-call duty to meet customer requirements
Job Responsibility
Job Responsibility
  • Proactively monitor and analyze real-time activities, performance, and operational status of Clearway Energy Utility Operating Assets to determine root cause and maintain utmost data integrity for operational events
  • Understand and proactively identify abnormal operating and alarm conditions that arise during the shift and react accordingly
  • Ability to manage power plant operations, considering different requirements for each plant based on location, generation type, interconnect requirements, regional regulations, and customer contractual requirements in a high-stress and time-sensitive environment
  • Answer phones and emails during the shift
  • Coordinate, document, and implement all necessary remedial actions to maximize the availability of the equipment and production/revenue according to pricing, resources, forecasts, and maintenance procedures
  • Interpret and execute activities associated with asset contracts (PPAs, LGIA’s, O&M agreements), including capacity scheduling/reporting, telemetry issues, or remote-control capability impacts
  • Operate multiple power plants IAW regulatory operating requirements (i.e., CPUC/WECC/Prudent Utility Practices)
  • Coordinate with the Field Operations teams, including Site Managers, Supervisors, and technicians, in daily activities for plant status verifications, downtime reporting, and safe actions of remote equipment
  • Coordinate with external entities such as Scheduling Coordinators, Transmission Operators, and Reliability Entities for the performance of status notifications or Operating Instructions
  • Support the commissioning of projects by coordinating test energy scheduling and power plant operations activities, ensuring safety, regulatory, environmental, and operating compliance
What we offer
What we offer
  • generous PTO
  • medical, dental & vision care
  • HSAs with company contributions
  • health FSAs
  • dependent daycare FSAs
  • commuter benefits
  • relocation
  • a 401(k) plan with employer match
  • a variety of life & accident insurances
  • fertility programs
  • Fulltime
Read More
Arrow Right

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...
Location
Location
Italy , Pomezia; Milano; Bologna; Alanno
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
  • Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
  • Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
  • Lead Auditor certification highly desirable
  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
  • Proven experience using digital tools and systems for supplier qualification and performance management
  • Exceptional communication, stakeholder management, and problem-solving skills
  • Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
  • Fluency in English required
  • Strong proficiency with Microsoft Office Suite and other business platforms
Job Responsibility
Job Responsibility
  • Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
  • Develop and maintain comprehensive supplier risk assessments and qualification documentation
  • Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
  • Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
  • Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
  • Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
  • Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
  • Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
  • Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
  • Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity
Read More
Arrow Right

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...
Location
Location
Italy , Bologna
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
  • Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
  • Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
  • Relevant certifications in Regulatory Affairs are considered a plus
  • Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
  • Strong attention to detail, time management and organizational skills
  • Willingness to learn and ability to work effectively in a team-based environment
  • Strong communication and interpersonal skills
  • Proficiency in Microsoft Office Suite and familiarity with document management systems
  • Fluent in English, both written and spoken
Job Responsibility
Job Responsibility
  • Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
  • Support regulatory strategies by providing impact assessments
  • Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
  • Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
  • Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
  • Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
  • Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
  • Assist colleagues with administrative tasks
  • Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
  • Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Client specialist - quality analyst

We are seeking talented individuals to join our team in Manila as Quality Analys...
Location
Location
Philippines , Manila; Taguig City
Salary
Salary:
Not provided
accesshealthcare.com Logo
Access Healthcare LLC
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Willing to work at our office in McKinley Hill, Taguig
  • Strong listening skills with attention to detail
  • Minimum 1 year of experience in Healthcare BPO as a Quality Analyst
  • Familiar with revenue cycle management process
  • Knowledge of Healthcare terminology will be added advantage
Job Responsibility
Job Responsibility
  • Listen to recorded and live customer interactions to assess agent performance, adherence to scripts, and compliance with company guidelines
  • Conduct thorough evaluations of calls, chats, and emails based on predefined criteria to measure service quality and identify areas for improvement
  • Provide constructive feedback and coaching to agents based on evaluation results to enhance their skills and performance
  • Generate regular reports on quality metrics, trends, and performance indicators to management, highlighting areas of excellence and opportunities for improvement
  • Collaborate with training teams to develop and deliver training materials and modules based on identified needs and trends
  • Identify process gaps, inefficiencies, and areas for enhancement in customer service operations, and propose solutions to streamline workflows and enhance overall service quality
  • Ensure that agents adhere to regulatory requirements, company policies, and industry standards in all customer interactions
  • Participate in quality improvement initiatives, calibration sessions, and team meetings to foster a culture of continuous improvement and excellence
Read More
Arrow Right

Food Quality Training Specialist

The Food Quality Training Specialist will supervise training and educate store t...
Location
Location
United States of America , Columbus
Salary
Salary:
Not provided
https://www.circlek.com Logo
Circle K
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or GED preferred
Job Responsibility
Job Responsibility
  • Supervise training and educating the store teams on current and new product offerings with an emphasis on Food Safety and Quality Assurance to ensure FSQA and HACCP regulatory requirements are met
  • Supervise new store start-ups and remodels for Foodservice
  • Address issues in stores in real-time and provide immediate and adequate solutions during each visit
  • Responsible for visiting all assigned stores on a set schedule to provide food safe-quality assurance monitoring functions
  • Conduct trouble-shooting seminars to instruct stores on how to fix equipment and process issues
  • Collaborate with Category Managers, BU leadership, store leadership, Food Service vendors and merchant experts to ensure training materials are effective, current, relevant and compatible with Company policies and standards in order to maximize future growth of the Foodservice category
  • Coach and monitor under-performing stores for improvement
  • Partner with District Managers for their specific opportunities and needs in their market
  • Oversee new food service projects based on BU initiatives
  • Maintain a database of all training sessions and visits
What we offer
What we offer
  • Equal Opportunity Employer
  • Reasonable accommodations available under the ADA.
  • Fulltime
Read More
Arrow Right

Quality Management Specialist

We are providing a contract for a fulltime employment opportunity for a Quality ...
Location
Location
United States , Oakland
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Possess strong management skills with the ability to oversee multiple tasks simultaneously
  • Proficiency in reporting and analytics, with a keen eye for data analysis and metric reporting
  • Demonstrated experience in strategic planning and implementation
  • Familiarity with drafting, interpreting, and implementing procedures and policies
  • Solid understanding of quality design and optimization principles
  • Knowledge in project management and the ability to handle multiple projects simultaneously
  • Excellent presentation skills with the ability to communicate complex information effectively
  • Must provide medical coverage knowledge and demonstrate understanding of clinical trial operations
  • Strong leadership skills, with the ability to inspire and motivate a team
  • Consulting experience, with the ability to provide expert advice and guidance
Job Responsibility
Job Responsibility
  • Lead the planning, coordination, and monitoring of clinical care and outcomes improvement strategies
  • Coach and consult individuals, departments, and multi-disciplinary teams on quality improvement processes and tools
  • Analyze existing care delivery models to identify opportunities for systems-based improvements
  • Oversee reporting requirements, establish guiding metrics, and benchmarks for performance improvement initiatives
  • Collaborate with medical information teams to design safe, high-quality workflows
  • Develop presentations to disseminate information and updates on improvement strategies
  • Facilitate and sustain performance improvement initiatives and activities in the healthcare setting
  • Ensure compliance with regulatory and accrediting agency requirements, maintaining a focus on data integrity, integration, and standardization
  • Assist in evaluating current and future quality initiatives within the health system
  • Advocate for best practices in patient safety, quality, and patient experience within the organization
What we offer
What we offer
  • medical, vision, dental, and life and disability insurance
  • eligible to enroll in our company 401(k) plan
  • Fulltime
Read More
Arrow Right

Quality Assurance Specialist for Contact Centre

We are looking for our next QA specialist for Contact Centre, main activities in...
Location
Location
Mexico , Ciudad de México
Salary
Salary:
Not provided
https://www.ikea.com Logo
IKEA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience on Contact Centre: Quality Assurance supervisor or similar
  • 1-3+ years of experience in a Contact Center environment, preferably in a Quality Assurance (QA) or Coaching role
  • Demonstrable prior experience monitoring and evaluating customer interactions (calls, emails, chat)
  • Experience conducting calibration sessions with leadership and training teams is highly desirable
  • Exceptional Attention to Detail: Must be meticulous in evaluating interactions against complex criteria
  • Strong Analytical and Critical Thinking Skills: The ability to be objective and data-driven in assessments
  • Outstanding Communication Skills (Written and Verbal): Essential for delivering clear, constructive, and professional feedback to agents and creating comprehensive reports for management
  • Coaching and Interpersonal Skills: The capacity to deliver feedback empathetically and motivate agents to improve their performance
  • Time Management and Organization: Ability to manage a high volume of monitoring tasks and meet deadlines
  • Problem-Solving: Proactive approach to identifying and proposing solutions for quality or process gaps
Job Responsibility
Job Responsibility
  • Monitor and evaluate agent-customer interactions (calls, emails, chat, etc.) to assess adherence to quality standards, policies, and procedures
  • Conduct call monitoring and scoring using established quality scorecards and evaluation criteria
  • Provide constructive and actionable feedback to contact center agents based on evaluation findings to drive performance improvement
  • Participate in calibration sessions with team leaders and trainers to ensure consistency and objectivity in the evaluation process
  • Analyze quality metrics (e.g., quality scores, Customer Satisfaction (CSAT), First Contact Resolution (FCR)) to identify trends, root causes of issues, and areas for improvement
  • Prepare comprehensive quality reports and performance analyses for management and relevant stakeholders
  • Collaborate with the Training and Coaching teams to develop and recommend targeted training programs based on identified skill and knowledge gaps
  • Assist in the development and maintenance of quality assurance standards, scorecards, and process documentation (SOPs)
  • Ensure agents comply with regulatory requirements and company policies related to customer interactions and data privacy
  • Identify and report systemic operational or process issues that impact customer experience or agent performance
  • Fulltime
Read More
Arrow Right

Specialist Manufacturing - Drug Product Operations

Join Amgen’s Mission of Serving Patients. At Amgen, our mission—to serve patient...
Location
Location
United States , Thousand Oaks
Salary
Salary:
114990.00 - 139433.00 USD / Year
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctorate degree
  • Master’s degree and 2 years of Manufacturing support experience
  • Bachelor’s degree and 4 years of Manufacturing support experience
  • Associate’s degree and 8 years of Manufacturing support experience
  • High school diploma / GED and 10 years of Manufacturing support experience
Job Responsibility
Job Responsibility
  • Initiate, revise, and approve controlled manufacturing documents within Amgen’s electronic document management system (CDOCs)
  • Serve as document author, owner, reviewer, or data verifier
  • Maintain documentation to accurately reflect operational practices and regulatory requirements
  • Support implementation of new processes, equipment, and major initiatives within Drug Product operations
  • Collaborate with Capital, Engineering, Process Development, Quality, and other functions to define requirements and achieve operational readiness
  • Assist in developing and implementing SOPs, batch records, training, validation, and automation configurations
  • Analyze manufacturing data and performance metrics to identify trends, deviations, and opportunities for improvement
  • Develop and implement data-driven solutions to improve yield, reliability, and compliance
  • Support data monitoring using analytical tools such as Enterprise Data Lake and Spotfire
  • Support timely investigation and resolution of manufacturing deviations
What we offer
What we offer
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Fulltime
Read More
Arrow Right