Position Summary: Eurofins Lancaster Laboratories is seeking a highly analytical and qualitydriven Data Reviewer Specialist to ensure accuracy and compliance of all stability protocols and study builds prior to client release. This position plays a crucial role in safeguarding data integrity and ensuring that client expectations are consistently met.
This role includes a structured training progression: the individual will be fully trained as a Stability Protocol Writer / Study Builder prior to performing protocol and study review responsibilities. This ensures a deep understanding of both the technical content and system workflows that impact the quality of client deliveries.
Key Responsibilities
Training Phase Protocol Writing & Study Building
- Complete comprehensive training in protocol writing based on Eurofinsgenerated quotes.
- Learn and practice building stability studies within the LIMS system following clientprovided protocols.
- Develop proficiency in interpreting client requirements scientific documentation and stability program workflows.
Primary Role Data Review
- Perform detailed independent review of stability protocols and study builds to ensure accuracy completeness and alignment with client expectations.
- Confirm that all protocol parameters (e.g. storage conditions pull points test plans) are correctly entered and consistent with both quotes and client-provided documents.
- Verify compliance with GMP internal SOPs and industry guidelines.
- Identify discrepancies errors or gaps and communicate effectively with Protocol Writers Project Managers and other stakeholders to resolve issues.
- Ensure documentation is traceable audit-ready and maintained in accordance with data integrity principles (ALCOA).
- Support continuous improvements in review workflows documentation standards and system utilization.
Qualifications :
Qualifications Required:
- Masters degree in a scientific discipline (Chemistry Biology Pharmaceutical Sciences or related field) or equivalent industry with 4-6 years of experience.
- Experience or familiarity with GMP data integrity expectations and regulated laboratory environments.
- Ability to learn and work effectively within LIMS or similar informatics systems.
- Strong scientific comprehension and ability to interpret technical protocols quotes and study plans.
- Exceptional attention to detail and commitment to data accuracy.
- Strong communication skills with the ability to constructively collaborate and provide clear feedback.
Additional Information :
Key Candidate Attributes:
- Self-motivation; excellent quality of work and attention to detail
- Ability to communicate effectively with coworkers and internal/external clients
- Ability to learn new tasks quickly and to move easily from task to task
- Ability to handle prioritization and multiple tasks simultaneously
- Ability to use a personal computer and learn necessary programs
- Good communication skills (oral and written)
- Organizational ability and good judgement
- Science background/education and/or laboratory experience
- Strong Math Skills
- Logical Thinking Good Reasoning Ability
- Motivation to excel
- Coaching/mentoring of peers
Remote Work :
No
Employment Type :
Full-time
Position Summary: Eurofins Lancaster Laboratories is seeking a highly analytical and qualitydriven Data Reviewer Specialist to ensure accuracy and compliance of all stability protocols and study builds prior to client release. This position plays a crucial role in safeguarding data integrity and ens...
Position Summary: Eurofins Lancaster Laboratories is seeking a highly analytical and qualitydriven Data Reviewer Specialist to ensure accuracy and compliance of all stability protocols and study builds prior to client release. This position plays a crucial role in safeguarding data integrity and ensuring that client expectations are consistently met.
This role includes a structured training progression: the individual will be fully trained as a Stability Protocol Writer / Study Builder prior to performing protocol and study review responsibilities. This ensures a deep understanding of both the technical content and system workflows that impact the quality of client deliveries.
Key Responsibilities
Training Phase Protocol Writing & Study Building
- Complete comprehensive training in protocol writing based on Eurofinsgenerated quotes.
- Learn and practice building stability studies within the LIMS system following clientprovided protocols.
- Develop proficiency in interpreting client requirements scientific documentation and stability program workflows.
Primary Role Data Review
- Perform detailed independent review of stability protocols and study builds to ensure accuracy completeness and alignment with client expectations.
- Confirm that all protocol parameters (e.g. storage conditions pull points test plans) are correctly entered and consistent with both quotes and client-provided documents.
- Verify compliance with GMP internal SOPs and industry guidelines.
- Identify discrepancies errors or gaps and communicate effectively with Protocol Writers Project Managers and other stakeholders to resolve issues.
- Ensure documentation is traceable audit-ready and maintained in accordance with data integrity principles (ALCOA).
- Support continuous improvements in review workflows documentation standards and system utilization.
Qualifications :
Qualifications Required:
- Masters degree in a scientific discipline (Chemistry Biology Pharmaceutical Sciences or related field) or equivalent industry with 4-6 years of experience.
- Experience or familiarity with GMP data integrity expectations and regulated laboratory environments.
- Ability to learn and work effectively within LIMS or similar informatics systems.
- Strong scientific comprehension and ability to interpret technical protocols quotes and study plans.
- Exceptional attention to detail and commitment to data accuracy.
- Strong communication skills with the ability to constructively collaborate and provide clear feedback.
Additional Information :
Key Candidate Attributes:
- Self-motivation; excellent quality of work and attention to detail
- Ability to communicate effectively with coworkers and internal/external clients
- Ability to learn new tasks quickly and to move easily from task to task
- Ability to handle prioritization and multiple tasks simultaneously
- Ability to use a personal computer and learn necessary programs
- Good communication skills (oral and written)
- Organizational ability and good judgement
- Science background/education and/or laboratory experience
- Strong Math Skills
- Logical Thinking Good Reasoning Ability
- Motivation to excel
- Coaching/mentoring of peers
Remote Work :
No
Employment Type :
Full-time
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