Change Control Specialist Job at Randstad (Strombeek-Bever)

Lead Project Controls Specialist - Quality

This position supports compliance with Capital Delivery project management polic...

Location

United States , New York

Salary:

94300.00 - 122256.00 USD / Year

AMTRAK

Expiration Date

Until further notice

Requirements

Minimum six (6) years of relevant experience in a quality control and\or assurance function and a Bachelor’s degree in Science or Engineering, or 10 years’ experience without a degree
Valid Driver’s License or ability to utilize an alternative method of transportation when needed to carry out job-related functions
Must have work authorization in the United States
Lean Six Sigma or process improvement training, certification, and/ or experience
Experienced in use of statistical analysis tools (Excel, SPSS, EngineRoom)
Familiarity with project management methods, techniques, standards, and best practices
Experience drafting technical documents such as standard practices, technical specifications, procedures, or policies
Ability to clearly organize and present reports, and other related technical information to upper management
Experienced in developing and delivering training

Job Responsibility

Prepare audit/compliance plans with sampling and test design for process measurement
Conduct audits, surveys, and performance reviews to ensure compliance with policies and best practices
Identify and recommend improvement opportunities across various management levels
Support development of corrective action scopes and monitor implementation
Conduct process mapping, quality checks, and audits to ensure data integrity and support data initiatives
Apply disciplined quality management common in manufacturing to construction projects
Identify gaps and inefficiencies and presents recommended improvement opportunities at various levels of management
Supports development of scope for corrective action or improvement projects
Track and monitor (or implement) corrective / preventive actions
Conduct process and value mapping activities

What we offer

health, dental, and vision plans
health savings accounts
wellness programs
flexible spending accounts
401K retirement plan with employer match
life insurance
short and long term disability insurance
paid time off
back-up care
adoption assistance

Fulltime

Regulatory Specialist

Regulatory Specialist (East Windsor, NJ) (Multiple Openings).

Location

United States , East Windsor

Salary:

Not provided

Novitium Pharma

Expiration Date

Until further notice

Requirements

Must have bachelors in Pharmaceutical sciences / biology / microbiology / chemistry / chemical / Regulatory Affairs / Related + 1 year exp. as Regulatory Specialist /Quality Control Analyst / Chemist / Analyst / Scientist/ Research Associate / Related

Job Responsibility

Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response letters, Information requests, Amendments to the ANDA’s (Labeling, Chemistry & Bioequivalence) of different dosage forms (Tablet, Capsule, Liquid & Solutions)
responsible for filing the Post Approval Supplements like CBE-0, CBE-30 (Changes being effective in 30 days) and Prior Approval Supplements (PAS)
submitting dossiers electronically after the approval of initial product submissions (ANDA)
review of the leachable and extractable reports generated for the oral Liquid & Solution drug products

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in scientific discipline
Advanced degree preferred
Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
Experience interacting with external testing laboratories preferred
Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
Strong team orientation and passion for continuous self-development
Experience in industry or in a startup industrial setting is preferred

Job Responsibility

GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
Batch Review / Release: Perform full batch record review of all types of investigations
perform appropriate quality control review of all QC data generated by third parties
draft, review, and approve CoA (internal/external)
Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures

What we offer

health and retirement
PTO
stock option plans

Technical Information Specialist

The person in this position is responsible for supervising and performing mail h...

Location

United States , Landover, MD

Salary:

Not provided

PN Automation, Inc

Expiration Date

Until further notice

Requirements

High School Diploma
Two(2) years direct experience processing documents
At least one (1) year of office, records, or computer experience
Ability to type 40 words per minute with no more than two (2) errors
Technical background with knowledge of folder structure systems for electronic documents
Proficient with office automation tools such as Microsoft Office and other common desktop applications
Must have a combination of excellent analytical skills and attention to detail
Possess excellent verbal and written communication skills
Must be able to lift and move standard boxes (up to 50 lbs)
Must be able to work in a fast-paced paper and electronic production environment

Job Responsibility

Supervising and performing mail handling in support of our customer, the Food and Drug Administration (FDA)
Performing all quality controls on documents processed
Interfacing with our clients to answer questions on how the work is being processed
Supervising mail receipt and delivery, logging, tracking and sorting mail, QC document manifest, etc.
Process paper and electronic documents in accordance with current SOPs
Perform data entry functions, as needed
Perform quality control checks on processed documents according to project requirements with 99% accuracy
Use office automation tools daily such as Microsoft Office and other common desktop applications
Use client specific databases with great proficiency
Make necessary changes to the work process, when requested

Fulltime

Document Management Specialist

We are currently looking for a Document Management Specialist join the Operation...

Location

Greece , Paiania

Salary:

Not provided

Metlen Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineer/IT or relevant field
6+ years of experience
3+ years of experience in Document Management
Working experience with industry standard document management systems
Effective communication and interpersonal skills
Strong problem-solving skills and attention to detail
Experience with leading the implementation of change projects
Experience with EPC is strongly preferred.

Job Responsibility

Lead change management to seamlessly deploy new solution on the selected in-flight multidisciplinary project
Timely problem-solve all issues that arise, to ensure business continuity and stakeholders buy in
Engage with project teams, IT and external developers to ensure deployment success, and escalate as appropriate to address blockers
Train and upskill project teams in use of DMS
Drive the deployment of new DMS solution across the organization, to enhance project execution and business operation efficiency
Upskill growing team of Document Controllers
Collaborate with IT, external developments, leadership and internal stakeholders to ensure seamless integration of DMS across the project lifecycle
Identify and promote opportunities where DMS can facilitate additional business operations
Drive culture of change within the division to adopt and maximize the benefits of digital transformation initiatives
Serve as a liaison between the project execution team and executive leadership to report progress, challenges, and recommendations related to DMS embedment

What we offer

Competitive remuneration package
Ticket Restaurant Card
Group Health Insurance program
Discount on the household electricity bill
Pension Plan
Cooperation, creativity and innovation: we adopt flexible cooperation models to achieve fast results and increased productivity.

Fulltime

Quality Assurance Specialist

The Quality Assurance (QA) Technical Services Specialist is a critical role for ...

Location

United States , West Greenwich

Salary:

113191.00 - 131832.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED & 10 years of Quality and/or Manufacturing experience
Associate’s degree & 8 years of Quality and/or Manufacturing experience
Bachelor’s degree & 4 years of Quality and/or Manufacturing experience
Master’s degree & 2 years of Quality and/or Manufacturing experience
Doctorate degree
Demonstrated experience leading enterprise risk management within GxP environments
Experience supporting Product Reintroductions (PRIs) and New Product Introductions (NPIs)
Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
Excellent written and verbal communication skills with cross functional teams, network, and management
Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance

Job Responsibility

Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures
Develop and maintain a working understanding of applicable requirements and best practices
Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations
as well as implementation of corrective actions, and change control
Manage the change control process, ensuring changes and implementation strategies are thoroughly evaluated for impact to quality
Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols
Ownership and subject matter expertise of quality processes including Deviation, CAPA, EV, Change Control and Quality Risk Management
Collaborate with project teams to integrate quality considerations and controls into project planning and execution
Independently assess and prioritize quality risks across various functions and processes
Implement proactive measures to prevent potential issues and ensure a state of inspection readiness

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Quality Assurance, Monitoring & Testing Specialist 5

The Central Testing function is primarily based out of Citi Service Centers in I...

Location

India , Pune; Chennai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

2-3 years of relevant work experience
Excellent written and verbal communication skills
Ability to perform under pressure
Ability to manage multiple tasks and priorities
Ability to function independently
Proficient in MS Office Word, Excel and PowerPoint applications
Bachelor’s/University degree

Job Responsibility

Have a good understanding of the Risk & control framework and the underlying concepts on Risk Management
Assist in performing the Quality check on the monitoring reviews that are defined per ARCM (Activity, Risk, Control & Monitoring)
Document the quality fails, any learnings or issues that may arise and pass the feedback to the Supervisor
Monitor the compliance of control as appropriate to the regulatory requirement
Provide inputs during the Control & Monitoring Design Assessment (CMDA) to draft and define the procedures
Involved in the assessment of the timeliness, accuracy and completeness of the MCA (Manager Control Assessment) through controls
Coordinate the adherence to the MCA Standard through controls after the execution of a process
Collaborating with onshore and offshore teams understanding the process changes if any and participate in trainings, meetings & etc.. Escalate any control failures
Complete the quality check within a timely manner to complement the results submission timeline in the Risk & Control system
Assisting in the creation and maintenance of reports for control tracking and analysis

What we offer

Access to telehealth options, health advocates, confidential counseling
Expanded Paid Parental Leave Policy
Resources to manage financial well-being
Access to learning and development resources
Generous paid time off packages
Resources and tools to volunteer in the communities

Fulltime

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

Change Control Specialist

Randstad

Location:
Belgium , Strombeek-Bever

Category:
Quality Control

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 05, 2026

Expiration:
May 23, 2026

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