Position Summary:
Eurofins Lancaster Laboratories is seeking a detailoriented and highly organized Stability Protocol Writer / Study Builder to join our team. This role is critical in supporting our stability program operations by transforming client requirements and Eurofinsgenerated quotes into accurate compliant protocols and complete study builds within the LIMS system.
The ideal candidate is comfortable navigating complex technical documents working with crossfunctional teams and ensuring all study components are aligned with Good Manufacturing Practices (GMP) and internal quality standards.
Key Responsibilities
- Translate Eurofinsgenerated quotes into fully developed compliant stability protocols within the LIMS system.
- Build stability studies based on clientprovided protocols ensuring all parameters are configured accurately.
- Collaborate with Project Management Study Management and Laboratory teams to ensure protocols and studies reflect correct requirements and timelines.
- Verify that protocol content aligns with regulatory expectations internal SOPs and client specifications.
- Maintain meticulous documentation and version control throughout protocol creation and study build processes.
- Identify and communicate any discrepancies or missing information to internal stakeholders or clients.
- Support continuous process improvements related to protocol writing workflow efficiency and system utilization.
- Ensure daily work complies with GMP data integrity expectations and Eurofins quality standards.
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 working within a regulated environment (GMP/GLP/GDP).
- Ability to interpret scientific protocols quotes and technical documents.
- Comfortable working with electronic systems such as LIMS or other laboratory informatics tools.
- Strong written and verbal communication skills including the ability to convey technical information clearly.
- Proven attention to detail and strong organizational skills.
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 detailoriented and highly organized Stability Protocol Writer / Study Builder to join our team. This role is critical in supporting our stability program operations by transforming client requirements and Eurofinsgenerated quotes into acc...
Position Summary:
Eurofins Lancaster Laboratories is seeking a detailoriented and highly organized Stability Protocol Writer / Study Builder to join our team. This role is critical in supporting our stability program operations by transforming client requirements and Eurofinsgenerated quotes into accurate compliant protocols and complete study builds within the LIMS system.
The ideal candidate is comfortable navigating complex technical documents working with crossfunctional teams and ensuring all study components are aligned with Good Manufacturing Practices (GMP) and internal quality standards.
Key Responsibilities
- Translate Eurofinsgenerated quotes into fully developed compliant stability protocols within the LIMS system.
- Build stability studies based on clientprovided protocols ensuring all parameters are configured accurately.
- Collaborate with Project Management Study Management and Laboratory teams to ensure protocols and studies reflect correct requirements and timelines.
- Verify that protocol content aligns with regulatory expectations internal SOPs and client specifications.
- Maintain meticulous documentation and version control throughout protocol creation and study build processes.
- Identify and communicate any discrepancies or missing information to internal stakeholders or clients.
- Support continuous process improvements related to protocol writing workflow efficiency and system utilization.
- Ensure daily work complies with GMP data integrity expectations and Eurofins quality standards.
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 working within a regulated environment (GMP/GLP/GDP).
- Ability to interpret scientific protocols quotes and technical documents.
- Comfortable working with electronic systems such as LIMS or other laboratory informatics tools.
- Strong written and verbal communication skills including the ability to convey technical information clearly.
- Proven attention to detail and strong organizational skills.
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
View more
View less