Qc Validation Specialist Job at Randstad (Singapore)

Senior QC Specialist (Method Validation & Technical Support)

The Senior QC Specialist (Method Validation & Technical Support) is responsible ...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline
Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment
Hands-on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls)
Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles

Job Responsibility

Lead analytical method qualification, validation, verification, transfer, and lifecycle management for chemical and biological testing
Manage qualification of laboratory equipment, analytical instruments, and critical reagents, ensuring compliance throughout their lifecycle
Support introduction of new methods, technologies, materials, and equipment into QC operations
Coordinate and maintain QC stability programs, including data review and trend analysis
Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events
perform root cause analysis and drive CAPA implementation
Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements
Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs
Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams
Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas

Fulltime

Specialist Qc Compliance

Role Overview: Specialist QC Compliance The Specialist QC Compliance acts as a S...

Location

Switzerland , Yverdon-les-Bains

Salary:

Not provided

Randstad

Expiration Date

July 31, 2026

Requirements

MSc in Biotechnology, Pharmaceuticals, Engineering, or equivalent industry experience
Minimum 5 years in a GMP environment, with at least 3-5 years specifically in Quality Control
Deep expertise in quality systems (Deviations, CAPA, Change Controls), hands-on equipment software qualification, and strong troubleshooting abilities
Proactive, rigorous, and team-oriented with a proven ability to build trust and work in highly regulated environments
Fluent in both French and English (C1 level or equivalent)

Job Responsibility

Oversee, document, investigate, and close quality events
Ensure the timely execution of deviations, root cause analyses, CAPAs, change controls, and periodic reviews
Coordinate the QC Data Integrity Plan, conduct risk assessments, implement mitigations, and deliver data integrity training to the team
Support the qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports)
Track equipment work orders, maintenance, and calibration records
Assist with QC sample management (reception, aliquoting, LIMS entry), material release, and monthly reviews of environmental monitoring system (EMS) alarms
Author, review, and maintain SOPs and related quality documents
Participate in audit/inspection readiness and address any observations
Monitor and coordinate the implementation of regulatory and pharmacopoeial updates

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

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

Qc Specialist Ii, Analytical Investigations

Life changing therapies. Global impact. Bridge to thousands of biopharma compani...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related field
2–5 years of QC Analytical Chemistry experience (pharma experience preferred)
Hands-on experience with UPLC, HPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Densitometer, and Osmometer
Solid understanding of cGMP, ICH, USP, and global compendia guidelines, especially in analytical method validation and stability studies
Strong organizational and documentation skills, technical writing ability, and excellent communication skills (written and verbal)
Ability to thrive in a fast-paced, dynamic environment, juggling multiple priorities while maintaining a sharp eye for detail
Proficiency in MS Office
experience with lab-based data management systems a plus

Job Responsibility

Lead investigations into QC Analytical deviations, OOS/OOT/OOE results, and other quality issues
Serve as a key point of contact during audits and inspections, ensuring timely and compliant responses
Draft and revise change controls, technical reports, cGMP documents, and protocols
Perform QC analytical testing, review data, and identify trends to proactively address risks
Assist in managing analytical equipment to maintain compliance and efficiency
Collaborate cross-functionally to close out quality events and audit findings on time
Help shape and refine QC processes that support continuous improvement

What we offer

Be part of a collaborative team where your expertise directly impacts patient safety and product quality
Gain exposure to diverse analytical techniques and regulatory processes
Opportunity to work in a GMP environment supporting both clinical and commercial product lifecycles
Professional growth through hands-on problem solving, cross-functional collaboration, and continuous learning

Fulltime

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

Qa specialist i

We are seeking for a Chemist and detail-oriented QC Technician. As a part of Phi...

Location

Philippines , Biñan

Salary:

Not provided

Sensient Technologies Corporation

Expiration Date

Until further notice

Requirements

bachelor’s degree in related fields plus extensive quality control experience in a commercial or manufacturing environment
knowledgeable of process/ instrument and equipment validation
knowledge in spectrophotometer/ colorimeter and microbiological laboratory is a plus
understands and can use basic statistical tools – Pareto Analysis, Control Charts, Correlation and Regression Analysis, etc.
comprehensive understanding in implementing ISO 17025 and conducting basic physico-chemical testing
familiar with JDE IT or other ERP system will be an advantage

Job Responsibility

routine testing per QC methods and protocols, including designing, conducting and analyzing measurement systems analysis
solve issues and analyze possible solutions using standard procedures, as well as participate in Formal Root Cause Analysis and implement corrective actions
use strong communication skills verbally and in writing to communicate internal lab data across departments and build relationships with teammates
be part of Food Safety team during Quality Audits to ensure positive outcome

What we offer

competitive pay
career advancement opportunities
opportunity to collaborate with colleagues onsite 5 days per week
thorough and constructive training experience during onboarding and beyond
shuttle bus various pick-up points within the city - Alabang & Pasig, nearby Laguna area

Fulltime

Warehouse Delivery Specialist

Our Story... QC Supply is seeking an experienced Warehouse Delivery Specialist. ...

Location

United States , Ames

Salary:

Not provided

QC Supply

Expiration Date

Until further notice

Requirements

High School Diploma or Equivalent
Valid Driver's License, with good driving record
Ability to read and understand basic English
Ability to function in a fast paced customer driven environment
Ability to lift up to 50 pounds unassisted
Pass a background check and pre-employment drug screening
Clean driving record

Job Responsibility

Verification of inbound product and entry of receipt information in the Microsoft NAV
Staging and put away of inbound materials into warehouse bin location utilizing Microsoft NAV
Accurate picking, packing and shipping of product to Customers, QC Sites and Vendor Partners
Aid in transfer into and stocking of the QC Supply on site retail space
Aid in performance of cycle counts and physical inventories within the Facility
Deliver product to local customers
Maintain a positive attitude and contribute to an environment of teamwork and collaboration
General housekeeping and sanitation of warehouse and retail workspaces
Other duties as assigned

What we offer

Medical
Dental
Vision
Life
Critical Illness
Accident and Group Legal Insurance
Flex Spending Account
Health Savings Account
paid holidays
paid time off (PTO)

Fulltime

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Qc Validation Specialist

Job Description

Job Responsibility

Requirements

What we offer

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