CrawlJobs Logo

GMP QC Specialist, CMC

cabalettabio.com Logo

Cabaletta Bio Inc

Location Icon

Location:
United States , Philadelphia

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be responsible for ensuring the compliance of generated QC data with Good Manufacturing Practices (GMP) both within the organization and generated by third parties. The individual will be involved in developing, implementing, and maintaining Quality Control review processes to uphold the highest standards in internal and external laboratory activities. The role will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant internal and regulatory requirements.

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
  • Risk Management: Identify and assess potential risks related to GMP compliance. Develop and implement risk mitigation strategies to minimize the likelihood of compliance issues
  • Continuous Improvement: Drive continuous improvement initiatives within the quality control function. Collaborate with relevant stakeholders to implement changes that enhance overall laboratory efficiency and quality
  • Communication: Effectively communicate with cross-functional teams, management, and regulatory agencies regarding quality control matters. Provide regular updates on compliance status, issues, and improvements to Quality Management

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

Nice to have:

  • Advanced degree preferred
  • Experience interacting with external testing laboratories preferred
  • Experience in industry or in a startup industrial setting is preferred
What we offer:
  • health and retirement
  • PTO
  • stock option plans

Additional Information:

Job Posted:
December 06, 2025

Work Type:
Hybrid work
Icon
Cabaletta Bio Inc - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon
PREMIUM
More languages and countries
+ Unlock 31048 hidden job offers
Languages
English Čeština Deutsch Ελληνικά Español Français +15
Countries
United States United Kingdom India Canada Australia +
See plans
Plans from $2.99 / month

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

Briefcase Icon

Similar Jobs for GMP QC Specialist, CMC

New

Waiter

Location
Location
United Kingdom , Knutsford
Salary
Salary:
12.71 - 13.50 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Previous experience as a Waiter or in a similar customer-facing role within the hospitality industry.
Job Responsibility
Job Responsibility
  • Provide impeccable table service, taking orders, serving food and beverages, and ensuring a positive and world class dining experience.
What we offer
What we offer
  • The Sunday Times – Best place to work 2024 & 2025
  • Full in-house training provided through our bespoke RISE programme
  • 50% off your food and drink bill at any of our restaurants, at any time, for up to 8 people
  • Enhanced Maternity and Paternity packages
  • Access to up to 40% of earnt wages and financial wellbeing tools through Wagestream
  • Employee Assistance Programme through The Drinks Trust, providing 24/7 support and access to counselling services
  • Career pathways and development through our high performers programme
  • 3% employer pension contribution
  • Team meals on shift
  • 15% off your grocery bill at Iceland Foods
  • Fulltime
Read More
Arrow Right
New

Freelance Media Buyer

Our client seeking a results-oriented Media Buyer to join our lean and agile Cor...
Location
Location
United States
Salary
Salary:
45.00 - 50.00 USD / Hour
cellainc.com Logo
Cella
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Platform Expertise: Proven track record of managing paid campaigns within LinkedIn Campaign Manager and Meta Business Suite
  • Analytical Mindset: Ability to not just report numbers, but to tell a story about why a campaign performed a certain way and how to improve it
  • Communication: Professional polish and the ability to present findings directly to internal 'clients' (colleagues) with clarity
  • Efficiency: Ability to work within a 4-6 week lead time, joining the project during the creative phase to ensure a seamless launch
  • Industry Background: While regulated industry (Pharma/Biotech) experience is not required, the ability to maintain a consumer-friendly, engaging tone while adhering to corporate standards is essential
Job Responsibility
Job Responsibility
  • Campaign Execution: Manage the end-to-end setup, flighting, and 'boosting' of paid posts on LinkedIn and Facebook/Meta
  • Audience Targeting: Utilize provided HCP and patient lists to build high-converting custom audiences
  • provide strategic input on potential audience gaps or new channel opportunities
  • Continuous Optimization: Monitor active campaigns (typically 3-month runs) and switch out creative assets to prevent ad exhaustion and maximize engagement
  • Reporting & Analytics: Distill complex platform data into clear, actionable 'merchandise-able' reports for internal stakeholders
  • Stakeholder Collaboration: Partner with the Social Media Lead, Content Writers, and Creative Directors to ensure the 'nitty-gritty' of campaign timing and delivery is flawless
  • Advisory: Provide insights on spend allocation, flighting schedules, and platform best practices to move the needle for our internal business partners
  • Compliance Awareness : Execute campaigns mainly using approved creative and copy
  • adhere to internal review, legal, and privacy-compliance processes
What we offer
What we offer
  • medical
  • prescription
  • dental
  • vision
  • AD&D
  • life insurance
  • short-term disability
  • 401K plan
Read More
Arrow Right
New

Payroll Administrator

We are looking for a Payroll Administrator to support accurate and timely payrol...
Location
Location
United States , Minneapolis
Salary
Salary:
90000.00 USD / Year
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3+ years of experience managing payroll administration in a detail-focused business environment
  • Hands-on experience with full-cycle payroll processing for a workforce ranging from approximately 101 to 500 employees
  • Working knowledge of multi-state payroll regulations and payroll compliance requirements
  • Proficiency with payroll platforms such as ADP Workforce Now, Paycom, or Yardi
  • Strong accuracy and attention to detail when handling sensitive employee and compensation data
  • Ability to collaborate effectively with accounting, HR, and employees across payroll-related processes
  • Clear communication skills and a service-oriented approach when addressing employee inquiries
Job Responsibility
Job Responsibility
  • Administer end-to-end payroll processing for employees, ensuring wages, deductions, and updates are completed accurately and on schedule
  • Maintain employee records by entering compensation adjustments, job status updates, and other payroll-related changes in a timely manner
  • Work closely with the accounting team to reconcile payroll activity and support accurate financial reporting
  • Support the hiring process by coordinating pre-employment screenings and collecting required documentation needed for payroll and benefits enrollment
  • Monitor completion of mandatory training paperwork and keep organized records in alignment with established deadlines
  • Respond to employee questions related to payroll, workers’ compensation, family and medical leave, and benefit-related matters
  • Help ensure payroll practices remain compliant with applicable policies and multi-state requirements
  • Use payroll and HR systems effectively to maintain data integrity and support daily payroll administration
What we offer
What we offer
  • Access to top jobs
  • competitive compensation and benefits
  • free online training
  • medical
  • vision
  • dental
  • life and disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Marine Project Engineer

We are seeking a skilled Project Engineer to support marine and heavy civil cons...
Location
Location
United States , Los Angeles
Salary
Salary:
140000.00 USD / Year
darwinrecruitment.com Logo
Darwin Recruitment GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Civil Engineering, Construction Management, Ocean Engineering, or a related field
  • Minimum 5 years of relevant experience in marine construction, heavy civil, or related projects, including field engineering or project management roles
  • Valid driver's license with a clean driving record
  • Ability to obtain or hold a TWIC (Transportation Worker Identification Credential)
  • Proficiency in Microsoft Office, AutoCAD, and document management software such as Bluebeam
  • Experience in construction document control, including RFIs, submittals, change orders, contracts, and progress reporting
  • Strong technical knowledge of field operations, layout, and surveying techniques
  • Excellent communication and organizational skills to coordinate teams, schedules, and materials
  • Ability to work on-site for extended periods, including out-of-town projects and occasional weekends
  • Commitment to safety, compliance, and quality standards in field operations
Job Responsibility
Job Responsibility
  • Support day-to-day field operations, assisting superintendents and foremen with planning and executing work activities
  • Coordinate labor, equipment, and materials to ensure work flows efficiently and safely
  • Maintain accurate daily production logs, equipment usage, and material tracking for project reporting
  • Monitor work quality and safety compliance, preparing documentation to meet internal and regulatory standards
  • Assist with project scheduling, identifying potential delays and proposing solutions to keep work on track
  • Conduct progress surveys, including cross-section and bathymetric measurements, to verify completed work
  • Support preparation of project documentation such as as-builts, progress photos, and compliance records
  • Serve as SSHO or QC Manager when assigned, ensuring adherence to safety, quality, and regulatory requirements
  • Communicate effectively with project management, vendors, and material suppliers to ensure smooth operations
  • Participate in safety meetings, toolbox talks, and technical briefings to foster a safe and productive field environment
  • Fulltime
Read More
Arrow Right
New

Senior Care Assistant (Nights)

As a Night Senior Care Assistant, you will provide high quality, individualised ...
Location
Location
United Kingdom , Hythe
Salary
Salary:
14.10 - 14.50 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 2 years' experience as a Care Assistant in residential care
  • Completed an L3 NVQ/Diploma in Health and Social Care
  • A compassionate and caring nature
  • Excellent communication skills and ability to use IT systems
  • Ability to lead and motivate staff members
  • Able to work on own initiative as well as part of a team
  • A flexible approach to working hours
Job Responsibility
Job Responsibility
  • Provide high quality, individualised care and support to residents during the night time
  • Promote each person's privacy, dignity and independence
  • Supervise and lead the shift and team members
  • Work together as a team to create a happy and caring atmosphere
What we offer
What we offer
  • Additional £2,000 attraction payment (£1,000 on joining and £1,000 on completion of probationary period)
  • Fulltime
Read More
Arrow Right
New

Payroll Administrator

We are looking for a detail-oriented Payroll Administrator to support payroll op...
Location
Location
United States , Hampton
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 2 years of payroll experience in a detail-oriented work environment
  • Working knowledge of accounting software systems and automated payroll tools
  • Experience handling timekeeping platforms, including systems such as About Time or similar applications
  • Understanding of core accounting functions related to payroll processing and reconciliation
  • Ability to conduct audits, review payroll data carefully, and correct discrepancies with accuracy
  • Strong attention to detail and ability to manage confidential information responsibly
  • Effective communication and organizational skills with the ability to meet scheduled deadlines
Job Responsibility
Job Responsibility
  • Process payroll accurately and on time for university employees while verifying pay data, deductions, and time records
  • Review timesheet and attendance information in automated timekeeping systems and resolve discrepancies before payroll is finalized
  • Maintain payroll records and supporting documentation in accordance with university policies and applicable regulations
  • Coordinate with accounting staff to reconcile payroll entries and ensure payroll activity is properly reflected in financial records
  • Perform payroll audits to identify inconsistencies, correct errors, and strengthen accuracy in recurring pay cycles
  • Respond to employee and department questions regarding pay, deductions, and payroll procedures in a clear and courteous manner
  • Support the use of payroll and accounting software by entering updates, validating data, and assisting with process-related system tasks as needed
What we offer
What we offer
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • Life insurance
  • Disability insurance
  • 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Senior CAD Specialist

We are seeking a Senior CAD Specialist with a strong background in Interior Arch...
Location
Location
United States , Los Gatos
Salary
Salary:
65.00 - 70.00 USD / Hour
cellainc.com Logo
Cella
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Interior Architecture, Architecture, or a related field
  • 5-10+ years of AutoCAD experience and 5+ years in a Corporate Real Estate or commercial architecture environment
  • Expert proficiency in AutoCAD and a deep understanding of office planning standards (circulation, support spaces, specialty areas)
  • Proficiency in calculating USF and applying BOMA standards
  • Ability to work independently in a fast-paced, deadline-driven environment with excellent attention to detail
  • Portfolio: Required. Must provide samples of commercial floor plans or technical design layouts.
Job Responsibility
Job Responsibility
  • Space Planning: Develop preliminary test fits, workstation layouts, and collaboration space plans for new and existing offices.
  • Feasibility Analysis: Evaluate floor plans against headcount requirements to inform lease-signing decisions.
  • CAD Management: Review, clean, and organize CAD drawings
  • polyline floor plans accurately following BOMA 2017 standards.
  • Stakeholder Collaboration: Rapidly revise plans based on feedback from Space Planners and business units.
  • Compliance: Ensure all conceptual plans reflect basic building codes, accessibility (ADA), and life-safety requirements.
  • Innovation: Assist the team in exploring and leveraging AI tools to automate and optimize the test-fit process.
What we offer
What we offer
  • medical
  • prescription
  • dental
  • vision
  • AD&D
  • life insurance
  • short-term disability
  • 401K plan
  • Fulltime
Read More
Arrow Right
New

Site Manager

Location
Location
United Kingdom , Aberdeen
Salary
Salary:
Not provided
darwinrecruitment.com Logo
Darwin Recruitment GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience delivering Battery Energy Storage System (BESS) projects
  • Previous experience managing both civil and electrical aspects of infrastructure or energy projects
  • Strong understanding of HV/MV electrical systems, ideally including 33 kV connections
  • Experience managing subcontractors and multidisciplinary site teams
  • Good knowledge of UK health & safety regulations and construction standards
  • Strong communication and stakeholder management skills
  • Ability to operate independently and provide strong on-site leadership
  • Relevant construction or engineering qualifications preferred
Job Responsibility
Job Responsibility
  • Lead and manage all on-site activities throughout the construction and commissioning phases of the project
  • Act as the primary on-site representative for the client
  • Coordinate civil, electrical, and BESS installation works to ensure programme milestones are achieved
  • Oversee site health & safety compliance in line with UK regulations and project standards
  • Manage subcontractors, suppliers, and site personnel
  • Ensure all works are completed in accordance with quality standards, specifications, and approved designs
  • Monitor project progress and provide regular updates to the client and project stakeholders
  • Coordinate interfaces between electrical and civil packages
  • Support commissioning activities and ensure successful project handover
  • Identify and mitigate site risks and resolve construction-related issues proactively
  • Fulltime
Read More
Arrow Right