Qc Validation Specialist Job at Randstad (Singapore)

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

Clinical Laboratory QC Specialist

The Clinical Laboratory Quality Control (QC) Specialist I performs and functions...

Location

United States , Madison

Salary:

76000.00 - 125000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemical, biological, or clinical laboratory sciences or medical technology from an accredited institution
For a degree not one of those listed above: 90 semester hours which must include 16 semester hours in chemistry (6 of which must be in inorganic chemistry)
16 semester hours in biology courses and 3 semester hours of math
2+ years of experience in a laboratory setting
1+ years of experience performing, reviewing and understanding quality control on a routine basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Authorization to work in the United States without sponsorship

Job Responsibility

All assigned job duties are performed following laboratory policies and procedures
Responsible for running daily QC scripts using statistical software and reviewing generated daily QC data
Responsible for identifying quality control issues, errors, and trends and promptly informing QC Specialist II and/or other QC team members of issues identified
May be requested to assist QC Specialist II and/or other QC team members in investigation of quality control issues, errors, and trends
May be requested to assist QC Specialist II and/or other QC team members in preparation of monthly quality control reports
Responsible for performing validations, verifications, and studies under the guidance of the QC Specialist II and/or other QC team members
Responsible for obtaining validation, verification, and study data for review
May be requested to assist in review of validation, verification, and study data
Assists QC Supervisor, QC Lead, and other QC team members in ensuring that all section turn-around times are maintained
Assists the QC Supervisor, QC Lead, and other QC team members by escalating concerns and answering technical questions from laboratory staff and others in Exact Sciences labs, as appropriate

What we offer

paid time off (including days for vacation, holidays, volunteering, and personal time)
paid leave for parents and caregivers
a retirement savings plan
wellness support
health benefits including medical, prescription drug, dental, and vision coverage
bonus eligible

Fulltime

Specialist, QC Systems

As the Specialist, QC Systems, you will support the design, implementation, and ...

Location

Canada , Vancouver

Salary:

76000.00 - 95000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

Senior Specialist I/II, Analytical Instrument and Systems Qualification

The Quality Control (QC) Specialist I/II—Analytical Instrument Qualification is ...

Location

United States , Durham, NC

Salary:

140000.00 - 185000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree required, preferably in a life science discipline with 10-12 years’ experience
Working understanding of various analytical techniques primarily flow cytometry, plate based assays, automated liquid handling, liquid chromatography, capillary electrophoresis, and next generation sequencing
Experience qualifying and sustaining a range of QC instruments (e.g., HPLC/UPLC, GC, CE, UV‑Vis, FTIR, TOC, qPCR/plate readers, balances, pH meters, osmometers, NGS, Flow Cytometers), including networked data systems and interfaces
Working knowledge of applicable regulatory expectations for e‑records/e‑signatures and computer systems (e.g., Part 11/Annex 11), with successful inspection support
Experience collaborating across multi‑site QC organizations and with equipment vendors to deliver validation to plan
Technical writing skills
Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
Advanced ability to communicate effectively with peers, department management and cross-functional peers
Documentation Excellence: Clear, complete, and audit‑ready authorship of URS, SIA, DIAS, CS, FDS, protocols, RTM, and QSR
Systems Thinking: Ability to define system boundaries, dependencies, and data flows

Job Responsibility

Lead or support onboarding of new analytical instruments, defining system boundaries, intended use, and qualification strategy in alignment with SIA and URS, including Draft, review, and secure approval of URS, SIA, DIAS, CS, and FDS deliverables
Author and execute IQ/OQ/IOQ/PQ protocols (as appropriate), ensuring test pre‑requisites, evidence, and deviations are documented and resolved prior to release for GMP use
Build and maintain the Requirements Traceability Matrix (RTM) to link requirements (URS/DIAS/CS/FDS) through protocol test cases and results
compile a Qualification Summary Report (QSR) to close projects
Define and verify data integrity and computerized system controls per DIAS (e.g., access management, audit trails, e‑records/e‑signatures, backup/recovery, calculations, data flows/interfaces) for instruments with embedded or attached control software
Initiate and/or execute change controls for instrument configuration changes, software upgrades, relocations, and method impacts
perform impact assessments and define re‑qualification needs
Perform/participate in periodic validation maintenance reviews to confirm lifecycle documents (SIA, URS, DIAS, CS, FDS, RTM, QSR) remain current and that assets stay in a validated state
Partner with QC SMEs, Digital Quality & Data Integrity, Validation, QA, IT, Facilities/Metrology, and vendors to plan and deliver qualification on schedule
coordinate service/vendor activities for installation, calibration, and PM in support of qualification and sustainment

Fulltime

Cleaning Validation Specialist

We are seeking a Cleaning Validation Engineer to lead and support cleaning valid...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related field
Strong experience in cleaning validation or cleaning qualification within pharmaceutical, biotech, or GMP-regulated manufacturing environments
Solid understanding of cleaning validation principles, strategies, and regulatory expectations
Experience preparing and reviewing cleaning validation protocols, reports, risk assessments, and related GMP documentation
Good knowledge of GMP manufacturing equipment, cleaning processes, and sampling methods such as swab and rinse sampling
Familiarity with cleaning validation lifecycle management, revalidation activities, and process improvement initiatives
Exposure to health-based exposure limits, MACO, PDE/ADE calculations, or worst-case product selection is preferred
Ability to work independently and provide technical guidance on cleaning validation topics
Experience supporting audits, inspections, remediation projects, or acting as a Validation Lead/SME is an advantage
Exposure to sterile manufacturing, biologics, vaccine, API, or pharmaceutical manufacturing environments is preferred

Job Responsibility

Lead and support cleaning validation / cleaning qualification activities for manufacturing equipment and processes
Develop, review, and execute cleaning validation strategies, protocols, and reports
Lead technical discussions related to cleaning approach, acceptance criteria, sampling strategy, and validation rationale
Review cleaning procedures, cleaning methods, and equipment cleaning practices
Support risk assessments related to product carryover, cross-contamination, equipment design, and cleaning effectiveness
Define or review acceptance limits, worst-case product selection, residue limits, and sampling points
Collaborate closely with Manufacturing, QA, Validation, Engineering, and QC teams
Ensure documentation is aligned with GMP, GDP, data integrity, and site quality requirements
Identify gaps in current cleaning validation practices and recommend practical improvement actions
Support audit readiness and respond to cleaning validation-related questions during inspections or internal reviews

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
Opportunity to turn ideas into action and make a tangible impact on sustainability
WeCare Together program to design and lead projects that create real social or environmental impact

Fulltime

Senior Quality Specialist

Climeworks is a leading high-quality carbon removal provider, combining decades ...

Location

Switzerland , Opfikon

Salary:

Not provided

Climeworks

Expiration Date

Until further notice

Requirements

You hold a degree in Chemistry or Analytical Chemistry
an advanced degree is a plus and strong applied laboratory experience is essential
You bring at least five years of industrial experience in a relevant field such as specialty chemicals, polymers, resins, or advanced materials manufacturing, with a proven track record in quality control and quality assurance
You are confident with material characterization and release testing, for example GC, IC, HPLC, FTIR, TGA, BET surface area, moisture and elemental analysis, and particle size methods, and you choose fit for purpose methods for routine release and investigations
You have deep expertise in method validation and verification, including designing protocols, defining specifications and acceptance criteria, estimating measurement uncertainty and detection limits, and ensuring data integrity across the full data life cycle
You have proven expertise in building and maintaining inspection ready documentation, authoring SOPs, test methods and work instructions, and operating within ISO based quality frameworks in fast growing environments
You are experienced in planning and conducting supplier and manufacturer audits on QC topics, assessing quality systems and measurement capability, gathering evidence, and driving effective corrective and preventive actions through to closure
You work fluently with LIMS and SAP QM for sample management, specification control, results review and release workflows, and you collaborate confidently with suppliers, manufacturers, Procurement, Product Owners and Operations
You communicate clearly and pragmatically in English.

Job Responsibility

You ensure robust quality control and quality assurance for sorbent materials and related QC processes in a dynamic scale‑up environment
You plan and coordinate QC campaigns for sorbents and related materials
You oversee measurements to meet workload and timelines
You review and approve QC data within defined QC specifications and testing standards
You maintain inspection‑ready documentation and records in SAP QM and linked systems
You manage deviations and change controls arising from QC activities and QC‑owned processes
You are responsible for method validation activities
You identify bottlenecks across QC processes and documentation as well as data handling
You act as the QC technical interface to suppliers and manufacturers
You support Procurement with commercial and contractual topics

What we offer

25 paid vacation days every year
public holidays
Hybrid work setup
Up to 4 weeks of remote work annually within any EU country
Fair base pay paired with an equity package
Inclusive parental leave
Dedicated budget to invest in your professional growth
Referral rewards

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis
Conduct the required testing, incubation and plate reading of these samples
Perform daily solution bioburden testing for total count and spore count
Perform processing of biological indicators to support sterilizer qualifications
Perform daily endotoxin and subvisible particulate testing of finished goods

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Microbiologist

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Canada , Alliston

Salary:

72080.00 - 108120.00 CAD / Year

Baxter

Expiration Date

Until further notice

Requirements

College diploma or University Degree in a related field (Microbiology)
Experience in a manufacturing environment
Proficiency in Word & Excel
Previous experience working in a Quality function
Knowledge of Aseptic Technique and Microbiological Methods
0- 2 years
Strong analytical and problem solving skills and critical thinking abilities
Strong communication skills, ability to work with all levels of the organization
Strong ability to balance multiple priorities with excellent time management skills
Detail oriented with the ability to work under pressure

Job Responsibility

Perform daily solution bioburden, subvisible particulate matter and endotoxin testing
Collect and process viable and non-viable air and surface samples as part of the Environmental Monitoring program
Sample and test the critical systems like compressed air and water
Process the biological indicators associated with sterilizer qualifications
Provide back up to the Supervisors and QC specialist to aide with investigations, trending and data analysis for APQRs, Validation Maintenance, etc
Obtain water, air and surface samples from designated sample sites within the facility on a daily, weekly, monthly and quarterly basis as part of the Environmental-monitoring program
Conduct the required testing, incubation and plate reading of these samples in accordance with specifications
Perform daily solution bioburden testing for total count and spore count in accordance with approved procedures
Conduct testing of raw materials as required
Perform processing of biological indicators to support sterilizer qualifications

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Select Country

Qc Validation Specialist

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?