Specialist Qc Compliance Job at Randstad (Yverdon-les-Bains)

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

Ongoing Due Diligence QC Specialist

Mercury is building a complete finance stack for startups. This turns out to be ...

Location

United States; Canada , San Francisco; New York; Portland; Remote

Salary:

85000.00 - 118800.00 USD / Year

Mercury

Expiration Date

Until further notice

Requirements

Be a highly motivated self-starter, comfortable working within a high-risk environment
Enjoy solving complex problems and be comfortable challenging existing ideas and flagging potential issues and opportunities
Work efficiently and independently, but ask for help when you need it
Enjoy and have experience working autonomously on both queue- and project-based work, and be able to switch between them comfortably
Demonstrate an emphasis on quality, accuracy, and detailed documentation in your daily work
Have a desire to improve processes and products within ODD and the greater Risk org
Have superb written communication skills, particularly for providing clear and actionable feedback
Expertly balance crafting feedback that shares constructive opportunities, celebrates work well done, and accounts for the needs of the person receiving it
Be curious and willing to learn about the US banking system, startups, and ecommerce companies

Job Responsibility

Perform regular QC assessments for the ODD team to ensure compliance with current policies and procedures
Maintain a strong working knowledge of ODD team processes and contribute to planning and implementation of quality-related projects within ODD
Provide feedback and recommendations to improve performance across the ODD team
Contribute to regular QC reporting and assist in maintaining QC procedures and process documentation
Help to monitor and analyze QC data to identify trends, anomalies, process gaps, and areas for improvement

Fulltime

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

QC Specialist

Quality Control Specialist ensures that all museum exhibits and other MOI produc...

Location

Croatia , Oroslavje

Salary:

Not provided

Museum of Illusions

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree in Engineering, with an emphasis on Mechanical engineering, or related field
At least 3+ years of related experience in QC in manufacturing or R&D
Ability to interpret technical drawings and design specifications
Knowledge of quality standards (ISO, GMP, etc.) and regulatory requirements
Strong attention to detail and analytical skills
Excellent communication and problem-solving abilities
Fluent English skills (written and spoken)
Category B driver's license

Job Responsibility

Perform testing of exhibit prototypes and materials
Perform quality checks of final products at suppliers location
Verify compliance with design specifications, durability standards, and safety regulations
Record inspection results, non-conformances, and corrective actions
Assist in root cause analysis and continuous improvement initiatives
Work closely with R&D team to identify potential design or material issues early in development
Participate in customer complaints analysis
Coordinate with other teams to resolve quality concerns promptly
Perform internal audits and supplier audits
Write procedures, work instructions and QC plans

What we offer

Full-time salaried position with a bonus structure
Supplementary and additional health insurance
A young, vibrant and ambitious team to work with
A fun, exciting and industry-leading concept to manage and develop in Zagreb
Reimbursement of travel expenses and provision of the warm meal

Fulltime

Specialist, GxP Compliance & Data Integrity

Beam is seeking a highly skilled Specialist I/II to join our growing Digital Qua...

Location

United States , RTP, North Carolina

Salary:

105000.00 - 145000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field with 10+ years of relevant experience
or Master’s degree in the same fields with 8+ years of relevant experience
Experience working in Quality Assurance, Validation, or IT Quality Assurance roles within the biotechnology or pharmaceutical industry
Experience working with systems like DeltaV, OSI PI, BAS, Kneat, Veeva, MES or comparable automation and data systems
Familiarity working with manufacturing platforms such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV is preferred
Experience with analytical instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, BacT with MYLA software, and other laboratory instruments
Experience with supplier management program for computerized system suppliers
Strong operational knowledge of risk-based tools, ALCOA+ principles, FDA and MHRA data integrity guidance, and 21 CFR Part 11/Annex 11 regulations is preferred
Prior experience working as a QA reviewer for embedded computerized systems – manufacturing equipment(s) and analytical instruments
Proven ability to implement cross-functional remediation plans aligned with the regulatory expectations for CSV/CSA and data governance

Job Responsibility

Oversee risk-based Computerized System Validation (CSV)/Computerized Software Assurance (CSA) activities across Manufacturing, QC, IT, Automation and Global Platforms, ensuring 21 CFR Part 11/Annex 11 and Beam’s internal policies and procedures
Support review and approval of validation lifecycle documents including but not limited to SIA, URS/SRS, CS, FDS, IQ, OQ, PQ, RTM and VSR, for embedded computerized systems and global platforms
Support authoring of CSV lifecycle and test documents, risk assessments and gap assessments as required
Collaborate with IT system owners, business systems owners, validation and product quality to deploy robust data integrity controls across systems and processes
Participate in Change Management activities to ensure controlled evaluation, qualification, and deployment of changes
Serve as SME and/or Quality approver on QMS records including change controls, continuous improvements, CAPAs, deviations and supplier qualification associated with computerized systems and data integrity
Review and ensure validation compliance for infrastructure systems such as DeltaV, MES, OSI PI, BAS, Clinical and Cloud systems
Act as data integrity SME by ensuring the enforcement of ALCOA+ principles and identifying critical data risks across manufacturing processes, QC methods, and computerized systems
Actively participate in the development of data integrity gap assessment program and assessment tools and eventual gap remediation activities by supporting identification of short term and long term mitigation strategies
Contribute to improvements in CSV/CSA and data integrity policies and procedures, user/functional group SME training and guidance

Fulltime

Senior Geotechnical Engineer

MinRes is seeking Senior Geotechnical Engineer to provide geological support to ...

Location

Australia , Bald Hill

Salary:

Not provided

Mineral Resources

Expiration Date

Until further notice

Requirements

Recognised tertiary degree in Civil, Geological Engineering, or Engineering Geology (or related discipline)
Experience working within an open pit production mining environment providing site-based monitoring, data collection and geotechnical engineering advice
Proficient in hazard mapping, data collection, stability modelling, and geotechnical reporting
Familiar with industry-standard mining and geotechnical software (e.g., RocScience suite, Surpac)

Job Responsibility

Ensure compliance with business geotechnical requirements, Mine Safety Regulations, and Principal Mining Hazard Management Plans (PMHMP)
Work with technical and operational stakeholders to implement and maintain the GCMP
Work with the technical services team to design and implement risk-based slope monitoring plans
Provide risk-based geotechnical advice for geotechnical hazard identification and control
Communicate site-specific geotechnical hazard awareness and best practice to the site workforce in formal training sessions
Support operations by providing specialist geotechnical inspection and advice related to the tailings storage facilities
Conduct geotechnical mapping of freshly exposed batters and maintain the geotechnical hazard map
Maintain monthly Quality Control (QC) reports focusing on geotechnical hazard management, pit slope monitoring, post blast assessment and design compliance
Apply a trigger-action response plan (TARP) system to monitor slope stability and respond proactively to progressive deformation trends
Maintain the fall of ground register, geotechnical mapping databases, and geotechnical work requests

What we offer

World Class Facilities: Experience mining excellence at sites equipped with cutting-edge facilities – enjoy award-winning meals crafted by MinRes’ own professional chefs
Career Development: We are committed to your professional growth. Upskill, lead, and thrive through industry-leading training, mentoring, and leadership development programs
Comprehensive Benefits: We value what matters most. Access a range of benefits designed to support your family, health, wellbeing, lifestyle, and financial future

Fulltime

Senior SCM Specialist

We are Subsea7, a global leader in the delivery of offshore projects and service...

Location

France , Paris

Salary:

Not provided

Subsea 7

Expiration Date

June 21, 2026

Requirements

Degree in a relevant discipline (Engineering or Business) or qualified by Experience
Is no required to solve technical issues (role of the Technical Owner) but shall be able to understand technical discussions and to measure potential associated commercial or schedule impacts
Is "cost saving" oriented, and capable of challenging requests
Have a good knowledge of the offshore industry and its specificities and of complex items
Demonstrate good communication skills and is a team player.

Job Responsibility

He/she manages procurement of complex “engineered” materials and/or services as allocated by the Project SCM Manager
He/she is globally responsible and accountable for the final delivery of the materials/services as per the requirements of the Project: technical specification, safety performance, budget, schedule, quality, contractual risks, etc.
He/she is responsible to the Project SCM Manager for the success of the SCM activities and deliverables for his/her procurement package in accordance with agreed schedules, milestones and cost, with focus on meeting the Project’s overall schedule and profitability
Pre-Award: He/she coordinates with other disciplines (Engineering, QA, QC & HSE) to ensure all requirements are included in pre-qualification and tender documents – including contractual flowdowns - and prepare/issue the Request for Quotation to the suppliers of the Bidders list using SAP Ariba tool
He/she coordinates with other disciplines to ensure the review and the clarification of all bids (he runs contractual, commercial and schedule analysis and he liaises and coordinates with other disciplines for on-time review and clarification of technical, quality and HSE sections)
He/she is responsible and accountable to finalise the bid summary and make the recommendation to the Project SCM Manager and to the Project Manager
He/she performs commercial negotiation and ensure the best deal for Subsea 7
He/She works with HSE advisor to assess safety criticality at Supplier Side (Albatros process)
Award Management: He/she prepares the Subcontract document
He/she prepares the Supplier Commitment Approval (SCA) and the contractual deviation matrix for Management approval

Fulltime

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Specialist Qc Compliance

Job Description

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