CrawlJobs Logo

GMP QC Specialist, CMC

cabalettabio.com Logo

Cabaletta Bio Inc

Location Icon

Location:
United States , Philadelphia

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

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
Job Link Share:
PREMIUM
More languages and countries
+ Unlock 31395 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

Product Manager - Food

Are you a passionate food product developer who thrives on bringing ideas to lif...
Location
Location
United Kingdom , Leeds
Salary
Salary:
45000.00 - 47000.00 GBP / Year
zestfoodjobs.co.uk Logo
Zest Food Jobs
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong experience within food product development, ideally in a retailer-facing manufacturing or branded environment
  • understanding UK retailer expectations, customer submissions and brand panel processes
  • confident managing critical paths, benchmarking products, reviewing samples and supporting first production runs
  • strong organisational skills, commercial understanding and ability to manage several projects simultaneously
  • resilience, energy and attention to detail
  • takes ownership, builds strong relationships, enjoys solving problems
  • hands-on approach and genuine passion for food innovation
  • full UK driving licence
  • flexibility for occasional travel
Job Responsibility
Job Responsibility
  • Manage multiple product development projects
  • coordinate suppliers, internal stakeholders and customer requirements
  • ensure launches delivered on time, to specification and to highest standards
  • provide category and market insight
  • identify emerging trends, spot opportunities and support future innovation
What we offer
What we offer
  • Package
  • Fulltime
Read More
Arrow Right
New

Delivery Driver

As a Car Delivery Driver, you'll be the face of Domino's in your local community...
Location
Location
United Kingdom , Barrow-In-Furness
Salary
Salary:
10.00 - 13.00 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Full, valid UK or International driving licence
  • Own a reliable, roadworthy car with valid MOT, tax, and insurance
  • Smartphone for delivery app use
  • Good knowledge of the local area
  • Friendly, reliable, and able to work independently
  • Able to work flexible hours, including evenings and weekends
Job Responsibility
Job Responsibility
  • Deliver pizzas and menu items to customers promptly and safely
  • Provide excellent customer service at every doorstep
  • Operate your vehicle in accordance with road safety regulations
  • Use the Domino's Delivery App on your smartphone to manage orders
  • Support the in-store team during quieter delivery periods (e.g. cleaning, restocking, folding boxes)
  • Represent Domino's positively in the community
What we offer
What we offer
  • Competitive hourly pay + per-delivery payment + tips
  • 28 days paid holiday per year (includes BH, pro rata for part time)
  • Flexible working hours to suit your lifestyle
  • Staff discount on our delicious food
  • Occasional Business Use insurance provided whilst out driving
  • Staff meals (conditions apply)
  • Company pension scheme (where eligible)
  • Family Leave policies in place
  • Paid training and clear career progression pathway with linked pay increases
  • Supportive, inclusive, and fun team environment
  • Parttime
Read More
Arrow Right
New

Primary Teacher

A phenomenal Primary School in the Borough of Barnet are on the hunt for a Prima...
Location
Location
United Kingdom , Barnet
Salary
Salary:
39157.00 - 56986.00 GBP / Year
https://edex.co.uk Logo
EdEx
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must have UK QTS
  • You must be ambitious, hardworking, committed and be academically talented
  • Good understanding of the Primary curriculum is required
  • Must be able to work in a team of fantastic Primary Teachers
  • You must set yourself high standards
  • You must meet the Teaching standards to a 'Good or Outstanding' level
Job Responsibility
Job Responsibility
  • Willing to work as a team
  • Eagerness to improve
  • Fantastic work ethic
  • Ambition & hunger
  • Must be able to inspire and motivate the younger generation
What we offer
What we offer
  • TLR opportunities – Maths, English, Humanities and Year Group Lead
  • ECT – Bespoke induction, in & out of house training and termly goals
  • Fantastic CPD opportunities
  • Great Leaders throughout the School
  • Modern facilities and additional support provided throughout
  • Fulltime
Read More
Arrow Right
New

Junior Digital Site Merchandiser

Location
Location
United Kingdom , London (Merton)
Salary
Salary:
29000.00 - 32000.00 GBP / Year
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 2 years’ experience with Salesforce B2C Commerce Cloud Platform & content management
  • Experience using Commerce Cloud Business Manager
  • Web/Digital merchandising expertise
  • Data driven
  • Strong analytical and numerical skills
  • An understanding of staging environments & basic HTML coding & web design experience a plus
  • Experience managing web-based analytical tools, such as Google Analytics, Power BI, Tableau
  • Strong PC Skills – Advanced Excel, Word, PowerPoint
  • Team orientated and willing to work as part of a collective
  • Able to deliver under pressure and prioritise accordingly
Job Responsibility
Job Responsibility
  • Assist with merchandising of inventory, catalogues, pricing, promotions, analysing shopping behaviour, and online visual appeal sitewide under the umbrella of driving revenue
  • Execute product assortment rules within Business Manager
  • Sort assigned product categories and subcategories, considering view type, image variants, swatches, image tags, and availability
  • Support with visual merchandising of PLP, PDP for the website
  • Ensure products are presented accurately and updated according to sales strategy, product launch calendar and business/analytics insight
  • Work alongside merchandisers to maintain B2C Commerce price books, export of product data catalogues, for new & existing content
  • Ensure product is made available to our customers, correctly merchandising group products across sites
  • Monitor and assess performance of all imported inventory feeds alongside content assets to assure the correct information is showing per site storefront
  • Applying manual HTML code and updates where needed
  • Identify any site errors related to inventory record, risk assess product's stock level and availability data in the context of each site or storefront inventory list
What we offer
What we offer
  • Staff discounts
  • Training
  • Health & Wellbeing support (includes Private Medical Health Insurance, EAP, Gym Discounts, Access to Financial Planning Service, etc.)
  • Cycle to work scheme
  • Generous annual leave allowance
  • Pension Scheme
  • Opportunity to develop new skills and progress in your career
  • Opportunity to work for a company that cares and believes in its people and the environment
  • Fulltime
Read More
Arrow Right
New

Primary Teacher + TLR

Primary Teacher + TLR | Permanent | September 2026 Start | Barnet A ‘Good’ Ofst...
Location
Location
United Kingdom , Barnet, London
Salary
Salary:
39480.00 - 59567.00 GBP / Year
https://edex.co.uk Logo
EdEx
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must have UK QTS
  • Strong understanding of the Primary curriculum required
  • You must show a passion and creative flare towards education and inspiring young minds
  • Understanding of the teaching standards
  • Lesson observations required: 'Good or Outstanding'
Job Responsibility
Job Responsibility
  • Inspiring and motivating the younger generation
  • Fulltime
Read More
Arrow Right
New

Hospitality Host

Nestled in historic Bearsden, Antonine House combines luxury surroundings with h...
Location
Location
United Kingdom , Glasgow
Salary
Salary:
12.76 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • experience of working within a front of house hospitality environment such as waitering and barista
  • excellent communication skills, with the ability to communicate effectively and demonstrate kindness, compassion and empathy
  • the ability to demonstrate knowledge of what excellent customer service looks like
Job Responsibility
Job Responsibility
  • meeting and greeting people, providing them with a warm friendly professional customer service
  • being proactive in providing refreshments to residents and visitors in the café areas and dining rooms
  • making sure the café is stocked with food, drinks, cakes etc and is a welcoming and stimulating environment to all
  • maintaining the cleanliness of the café to the highest of Meallmore standards
  • working alongside the care team ensuring residents have great experiences
  • a keen eye for detail to ensure the home is always looking its best
What we offer
What we offer
  • Wagestream (access a portion of your earned income – every hour of every day)
  • Hourly overtime rates available
  • Free uniform
  • Investment in your ongoing professional development, including our mentorship scheme
  • Refer a friend bonus scheme (up to £1000)
  • Pension scheme
  • Company sick pay scheme
  • Parttime
Read More
Arrow Right
New

Support Worker

Our Meallmore team at Manor are ready to warmly welcome you as a Care Assistant ...
Location
Location
United Kingdom , Nairn
Salary
Salary:
13.50 GBP / Hour
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Working towards the qualification to meet SSSC registration requirements
  • SVQ level 2 or above/equivalent in Health and Social Care (as per SSSC guidelines) is desirable
  • Communication and repour building skills
  • Kind caring nature
Job Responsibility
Job Responsibility
  • To promote/provide a high quality of care and support in accordance with Individual care/support plans
  • To assist in creating wellbeing within a caring environment and be involved in the general activities of the home
  • To adhere to Meallmore Standards, Policies and Procedures, National Care Standards
  • To work in line with the SSSC codes of Practice
  • Collaborate with care staff in your department and wider teams
  • Carry out personal care duties
What we offer
What we offer
  • Wagestream (access a portion of your earned income – every hour of every day)
  • Subsidised meals
  • Hourly overtime rates available
  • 28 days annual leave pro rata
  • Free uniform
  • Investment in your ongoing professional development, including our mentorship scheme
  • Refer a friend bonus scheme (up to £1000)
  • Pension scheme
  • Company sick pay scheme
Read More
Arrow Right
New

Care & Support Worker Days

Join our friendly, supportive and inclusive team at High Haven to help us make a...
Location
Location
United Kingdom , Downham Market
Salary
Salary:
13.81 GBP / Hour
norsegroup.co.uk Logo
Norse Group LTD
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience as a Care professional or new to the industry
  • Passion for supporting others
  • Alignment with core values: care completely, collaborate proactively, act with integrity, pursue better, make it happen
Job Responsibility
Job Responsibility
  • Assist with personal care and support tasks
  • Enable service users to make informed choices, promoting their independence and dignity
  • Work as part of a team, build strong relationships
  • Participate and support with wellbeing events and activities
  • Respond to call bells and emergencies
  • Communicate with other medical professionals and community stakeholders
What we offer
What we offer
  • Fully funded accredited courses
  • Career progression
  • Weekend working enhancements
  • Access to Blue Light Card
  • Physiotherapy and chiropractor treatment
  • Enhanced DBS check paid by employer
  • Parttime
Read More
Arrow Right