Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day as we enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve their career goals while helping to take science a step beyond by developing solutions to some of the world’s toughest challenges, including protecting the environment, ensuring food safety and supporting the development of life-changing therapies.
Position Summary
As the Quality Specialist – Lab Operations Oversight, you will provide Quality oversight and leadership for GMP laboratory activities, ensuring that laboratory operations, documentation, testing practices, and associated Quality records comply with applicable regulatory requirements, company procedures, and data-integrity principles.
The primary focus of this role is to provide effective, independent Quality oversight of laboratory operations, identify and communicate compliance risk, support timely resolution of laboratory Quality issues, and promote a state of inspection readiness and sustained Quality performance.
Essential Functions
- Provide Quality review and approval of laboratory documentation, protocols, reports, investigations, deviations, and other GMP records to ensure completeness, accuracy, compliance, and adherence to approved procedures and data-integrity expectations.
- Review and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, laboratory deviations, corrective and preventive actions (CAPAs), and risk assessments, applying sound Quality and technical judgment to ensure appropriate investigation, root-cause evaluation, impact assessment, and corrective action.
- Serve as the primary Quality liaison for laboratory and cross-functional teams, providing Quality guidance, interpreting applicable requirements, and supporting timely resolution and escalation of laboratory-related Quality and compliance issues.
- Partner with Quality Project Leads and participate in client meetings, serving as a Quality subject matter expert for laboratory investigations and associated Quality-system activities.
- Support Client Business Review meetings by presenting and discussing laboratory investigation trends, Quality metrics, and Key Performance Indicators, as appropriate.
- Support the generation, review, and assessment of quarterly and annual laboratory trend reports and other Quality metrics to identify recurring issues, emerging risks, and opportunities for improvement.
- Perform GEMBAs and other Quality oversight activities within laboratory areas to assess adherence to procedures, GMP requirements, documentation practices, data-integrity expectations, and established Quality standards. Conduct in a manner that promotes compliance, open communication, proactive risk identification, and a strong culture of Quality.
- Partner with laboratory leadership and key stakeholders to proactively identify compliance risks, evaluate Quality-system performance, and support appropriate actions to maintain a compliant state.
- Promote laboratory inspection readiness through routine Quality oversight, identification and escalation of compliance gaps, and support for sustainable remediation and continuous improvement.
- Monitor laboratory Quality performance, evaluate trends and recurring issues, and support the development and implementation of sustainable improvements that strengthen compliance, operational effectiveness, and the laboratory Quality system.
- Build effective working relationships across Quality, laboratory, Operations, project teams, and other functions while maintaining appropriate Quality independence and exercising sound Quality judgment.
- Demonstrate consistent commitment to data integrity, regulatory compliance, product quality, patient safety, operational excellence, and a strong culture of Quality.
Education
Bachelor’s degree in Chemistry, Microbiology, Engineering or Biotechnology
Experience
- Minimum of 5 years of relevant experience in the pharmaceutical, biotechnology, food, medical device, or other regulated industry, including experience working in a GMP-regulated environment.
- Experience reviewing and/or approving GMP documentation and Quality records, such as laboratory investigations, deviations, OOS/OOT investigations, CAPAs, risk assessments, protocols, reports, or comparable records.
- Experience assessing Quality or compliance issues, evaluating investigation adequacy and root cause, and supporting appropriate corrective and preventive actions.
- Experience applying GMP requirements and data-integrity principles to laboratory operations, documentation, testing practices, or associated Quality systems.
- Experience working collaboratively with laboratory, Quality, Operations, and other cross-functional stakeholders to communicate and resolve Quality and compliance issues.
- Experience evaluating Quality metrics, investigation trends, or other Quality-system data and using the results to identify risks or improvement opportunities preferred.
- Experience with continuous improvement or operational-excellence principles within a regulated environment preferred.
Equivalency
An equivalent combination of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
- Strong working knowledge of GMP requirements and Quality-system principles as they apply to laboratory operations, documentation, testing practices, investigations, and associated records.
- Strong understanding of Quality oversight responsibilities, including the ability to independently evaluate laboratory activities and records for compliance with approved procedures, regulatory expectations, and established Quality standards.
- Knowledge of data-integrity principles and the ability to recognize, assess, escalate, and support resolution of potential data-integrity or documentation concerns.
- Knowledge of and ability to apply requirements and Quality principles associated with OOS/OOT investigations, laboratory deviations, CAPAs, risk assessments, root-cause analysis, and investigation effectiveness.
- Ability to critically review laboratory documentation, protocols, reports, investigations, and Quality records for scientific rationale, completeness, consistency, procedural compliance, and Quality impact.
- Ability to apply risk-based Quality judgment when evaluating laboratory events, investigation conclusions, compliance gaps, corrective actions, and potential impact to product quality or patient safety.
- Strong analytical and problem-solving skills, including the ability to interpret Quality-system data, laboratory investigation trends, and Key Performance Indicators to identify recurring issues and emerging compliance risks.
- Ability to identify compliance risks and clearly communicate appropriate recommendations, required actions, and escalation needs to laboratory leadership, Quality management, project teams, and other stakeholders.
- Strong interpersonal, collaboration, influencing, and negotiation skills, with the ability to build effective partnerships while maintaining appropriate Quality independence and objectivity.
- Ability to lead or facilitate cross-functional discussions regarding laboratory investigations, Quality risks, CAPAs, trends, and improvement opportunities.
- Strong written and verbal communication skills, including the ability to document Quality decisions and rationale clearly and to present investigation outcomes, Quality risks, trends, and metrics to stakeholders, clients, and management.
- Ability to manage multiple laboratory Quality priorities and make timely, risk-based decisions within established timelines.
- Highly organized and detail-oriented, with strong follow-through and documentation practices.
- Ability to work independently and exercise sound Quality judgment while contributing effectively within cross-functional teams.
- Ability to adapt to changing priorities and appropriately prioritize activities based on compliance risk, product quality, patient safety, client commitments, and business needs.
- Understanding of continuous-improvement and risk-management principles and their application within a GMP laboratory Quality environment.
- Strong Quality, compliance, operational, and client-service mindset.
- Understanding of the contract manufacturing industry preferred.
- Proficiency with Microsoft Office applications and applicable electronic Quality or laboratory systems, as required.
- Proficiency in the English language.
Standards and Expectations
- Follow all Environmental Health and Safety policies and procedures and maintain safe and orderly working practices Perform all responsibilities in compliance with applicable GMP requirements, approved procedures, Quality-system requirements, data-integrity principles, and site policies.
- Maintain a consistent focus on the role’s primary responsibility of providing effective Quality oversight of laboratory operations and ensuring that Quality decisions are objective, appropriately documented, risk-based, and compliant.
- Exercise appropriate Quality judgment and promptly identify, communicate, and escalate laboratory Quality, compliance, data-integrity, product-quality, or patient-safety concerns.
- Ensure Quality reviews and approvals are thorough, timely, scientifically sound, and supported by appropriate documentation and rationale.
- Promote a state of inspection readiness by maintaining strong Quality oversight, identifying compliance gaps, supporting timely remediation, and ensuring sustainable corrective actions.
- Monitor laboratory Quality performance and relevant Key Performance Indicators and proactively identify adverse trends, recurring issues, and opportunities to strengthen laboratory Quality systems.
- Partner collaboratively with laboratory leadership and cross-functional teams while maintaining appropriate Quality independence, objectivity, and accountability.
- Communicate Quality risks, investigation concerns, compliance gaps, resource constraints, and potential timeline impacts promptly and clearly to appropriate stakeholders.
- Communicate effectively with clients and external stakeholders regarding laboratory Quality issues, investigations, trends, and performance within the scope of assigned responsibilities.
- Model professional, collaborative, inclusive, and accountable behaviors and contribute to a strong site Quality culture.
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.