Change Control Facilitator Job at Randstad (Latina)

QA Specialist I - Operations

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Madison

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 3-5 years of pharmaceutical or biotech industry experience with 2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
ASQ certification preferred
Exceptional organizational skills and attention to detail
Ability to make risk based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, Excel, Access and Visio

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements
Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation

Fulltime

QA Specialist I

The QA Specialist will work with other departments to ensure the quality of prod...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a relevant scientific field
3-5 years of pharmaceutical or biotech industry experience
2+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approval of Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participation in the management review process

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – External Operations will work with other departments to ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process

Fulltime

Sr. QA Specialist - Ops

The Sr. QA Specialist – Team Lead will work with other departments to ensure the...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

7-9 years of pharmaceutical or biotech industry
4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
Bachelor’s Degree in a relevant scientific discipline preferred
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ
Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
Ability to Travel 10%

Job Responsibility

Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
Provide direction for complex investigations and CAPAs
Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
Review, develop, and improve quality system procedures, specifications, and test methods
Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process

Fulltime

Business Systems Manager II – Financial Systems Operations

The Finance Operations organization is seeking a seasoned leader to drive financ...

Location

United States , Broomfield, Colorado

Salary:

149603.00 - 254317.00 USD / Year

Baesystems

Expiration Date

Until further notice

Requirements

BS/BA in related field plus 10 years or more related experience
10 years or more experience in Aerospace and Defense (A&D) or similar government contracting environment
Experience in people leadership, with a proven track record of successfully managing and developing high-performing teams
Experience in Project Controls, Financial Reporting and/or Financial Planning & Analysis with FAR, DFARS, and CAS understanding
Systems and tools Implementation or upgrade experience
Excellent communication skills
Solid financial acumen related to program finance in a government contracting environment including the understanding of Financial Forecasting, Earned Value Management, and Cost Control practices
Proven experience in process improvement and project management
Experience in financial systems, data analysis, and report development
Solid leadership and management skills, with the ability to attract, retain, and develop top talent

Job Responsibility

Collaborate with leadership and stakeholders to oversee daily management of financial tools and applications, ensuring effectiveness, compliance, and accuracy
Provide configuration, administration, and financial reporting development support for financial systems, driving efficient and reliable operations
Support critical business cycles, including financial monthly, quarterly, and annual processes, to ensure timely and accurate financial reporting
Lead system change control board activities, facilitating change control processes, documentation, and implementation of changes to minimize risk and ensure seamless system operations
Drive process improvements through enhancement, automation, and analysis of financial processes for systems solutions, optimizing efficiency and effectiveness
Participate in system upgrades, testing, and patch management to ensure reliable system functionality, data integrity, and business reporting needs
Define Business Requirements: Collaborate with stakeholders to identify and document business needs and goals
Provide Program Finance Business Subject Matter Expertise: Liaise between business and technical teams on requirements, processes, and data
Lead Project Scheduling and Resources: Partner with ITS project manager to meet milestones and objectives
Develop, Test, and Deploy Solutions: Collaborate on development, testing, and go-live readiness

What we offer

health, dental, and vision insurance
health savings accounts
a 401(k) savings plan
disability coverage
life and accident insurance
employee assistance program
legal plan
discounts on things like home, auto, and pet insurance
paid time off
paid holidays

Fulltime

Change Control Lead – Quality Operations

We are seeking an experienced Change Control Lead – Quality Operations to suppor...

Location

Canada , Toronto

Salary:

50000.00 - 110000.00 CAD / Year

Amaris Consulting

Expiration Date

Until further notice

Requirements

5–7 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment
Strong hands-on experience executing change controls within a Quality Management System
Solid knowledge of GMP and audit-ready documentation practices
Proven ability to lead cross-functional discussions and drive actions to closure
Leadership experience or strong leadership capability
Ability to work on-site in Toronto most days, preferably daily at the beginning

Job Responsibility

Own and drive the full change control lifecycle from initiation to closure, including scope definition, impact and risk assessments, action planning, implementation oversight, effectiveness checks, and closure
Ensure appropriate routing and approvals across Quality, Engineering, Manufacturing, Supply Chain, IT, Validation, and other relevant functions
Author, review, and improve high-quality change records with clear rationale, justification, and traceability
Triage and prioritize incoming change requests
support stakeholders in defining implementable and compliant changes
Maintain trackers, manage backlogs, escalate risks or delays, and propose recovery plans
Facilitate and document quality risk assessments (e.g., FMEA or equivalent)
Ensure alignment with GMP, data integrity expectations, and site quality standards
Link change controls to deviations and CAPAs when applicable and ensure timeline alignment
Coordinate validation and qualification impact assessments (IQ, OQ, PQ, CSV, requalification)

What we offer

An international community bringing together more than 110 different nationalities
An environment where trust is central: 70% of our leaders started their careers at the entry level
A strong training system with our internal Academy and more than 250 modules available
A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Fulltime

Transport Supervisor

Fantastic opportunity as a Transport Supervisor, Adaptable Work Structure and Ef...

Location

Australia , Brisbane

Salary:

Not provided

People Group

Expiration Date

Until further notice

Requirements

Willingness and ability to follow process and procedures
Intimate knowledge of the geographical layout and road system in the Brisbane area
Strong customer service orientation
Ability to attend to detail with a high degree of accuracy
Good to intermediate computer literacy / keyboard skills
Strong numerical and literacy skills
Effective time management and self discipline
Problem solving ability with decisive decision making
Ability to find and/or create solutions for customers
Strong management on cost control

Job Responsibility

Execute the daily load and route plan for all channel deliveries
Direct the Independent Contractors in their execution of the daily load and route plan
Ensure permanently placed fleet vehicles are on site
Abide by the predetermined daily load quantities for Independent Contractors
Monitor daily loads to ensure service delivery to clients
Ensure the data completion of all loads ‘live’ in FMS and PC Despatch
Ensure any and all issues are dealt with immediately and a solution found as they arise
Control and monitor the daily and weekly revenue plan
Compile all relevant required paperwork from previous day and ensure data is entered
Communicate all/any delivery/pickup issues with Contractual Clients and other customers

Fulltime

Svp – Wealth Business Risk And Controls – Business Regulatory Risk Management

Individuals in Risk Assessment & Controls' design are responsible for developing...

Location

United Arab Emirates , Dubai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Minimum of 8-10 years of experience in regulatory change management, compliance, audit, or other control-related functions in the financial services industry
Demonstrated experience with regulatory inventory management and internal control programs
Strong understanding of relevant financial services regulations (e.g., AML, KYC, consumer protection, data privacy, prudential regulations) is highly valued
Exceptional analytical skills with the ability to interpret complex regulatory texts, assess their practical implications, and identify root causes of risk
Excellent written and verbal communication skills, with the ability to articulate complex issues clearly and concisely to diverse audiences, including senior management and regulators
Proven project management and organizational skills, with the ability to manage multiple priorities and meet tight deadlines
High level of attention to detail and accuracy
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and experience with governance, risk, and compliance (GRC) tools is a plus
Education: Bachelor's/University degree or equivalent experience

Job Responsibility

Regulatory Change Management: Actively collaborating with business to identify, evaluate, and manage regulatory adherence risks arising from the definition of business strategy, development of new products and services, changes in regulations or internal policies, or from business-led changes
Working with business, Legal & ICRM to facilitate regulatory change management activities by performing comprehensive impact assessments of regulatory changes on existing business processes, policies, procedures, systems, data requirements, and the overall control environment
Develop and implement structured project plans for the timely and effective integration of regulatory changes across relevant business units
Actively collaborate with business units to identify, evaluate, and manage regulatory adherence risks arising from new regulations or internal policy changes, documenting identified gaps and required actions
Facilitate communication and training programs on regulatory changes
Track the implementation status of regulatory changes
Regulatory Review & Exam Management: Serve as Controls point of contact for all regulatory examinations, audits, and inquiries from supervisory authorities
Coordinate and facilitate all aspects of regulatory reviews, including meticulous information gathering, comprehensive document production, scheduling and logistical management of meetings, and managing clear and consistent communications between regulators and internal stakeholders
Prepare and rigorously review responses to regulatory requests
Track, monitor, and report on all regulatory findings, recommendations, and the status of remediation efforts

Fulltime

Change Control Facilitator

Randstad

Location:
Italy , Latina

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 24, 2026

Expiration:
May 26, 2026

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Job Description:

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