Extractables and Leachables Data Reviewer

Jobtailor; Deutschland; Remote; EUR 78.000 - 112.000; Vollzeit

Zusammenfassung

Jobtailor seeks a meticulous reviewer to validate routine and complex analytical work in pharmaceutical contexts. You will ensure methods are followed, data are accurate, and final reports meet GMP/GLP standards.

Join a collaborative team capable of remote work, driving quality improvements while supporting diverse projects and training staff as needed.

Qualifikationen

• Must be legally authorized to work in the United States
• Must pass a comprehensive background check, including drug screening
• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification
• 2+ years of comparable experience, or equivalent combination of education, training, and experience
• Previous experience with formal data review in a GMP laboratory strongly preferred
• Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP
• Thorough knowledge of chromatography may be required
• Strong technical knowledge of laboratory procedures, methodology, and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to balance time and remain focused on work to meet goals
• Ability to train staff on basic review techniques
• Ability to independently review laboratory reports and analytical methods
• Ability to handle multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment
• Ability to work efficiently in a remote capacity
• Ability to communicate, receive, and understand information and ideas with diverse groups of people
• Ability to work upright and stationary and/or standing for typical working hours
• Ability to lift and move objects up to 25 pounds
• Ability to work in non-traditional work environments
• Ability to use and learn standard office equipment and technology proficiently
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities

Aufgaben

• Review routine and complex analytical analyses involving pharmaceutical and biopharmaceutical compounds, formulations, and biological matrices
• Ensure analyses follow validated or experimental analytical procedures
• Compare results with methodology, protocols, product specifications, SOP acceptance criteria, and GMP requirements
• Review data entered into databases and reports
• Monitor laboratory data quality
• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs
• Review sample results for scientific soundness, completeness, accurate data representation, and final reported results
• Communicate with laboratory staff to maintain the quality of laboratory documentation
• Deliver clear and concise findings on deficiencies in analytical data or reports
• Escalate significant deficiencies to project leaders or supervisors
• Facilitate discussions with laboratory staff about documentation practices and quality findings
• Advocate for quality and review process changes
• Identify and support process improvement initiatives
• Perform other assigned duties

Kenntnisse

GMP Knowledge

GLP Knowledge

SOP Compliance

Analytical Data Review

Documentation Practices

Quality Control

Strong Communication

Attention to Detail

Time Management

Collaboration

Process Improvement

Data Review

Methodology Evaluation

Ausbildung

Bachelor’s degree or equivalent

Tools

Laboratory Equipment

Data Management Software

Office Equipment

Jobbeschreibung

• Review routine and complex analytical analysis experiments involving pharmaceutical and biopharmaceutical compounds, formulations, and biological matrices
• Ensure analyses follow validated or experimental analytical procedures
• Compare results with methodology, protocols, product specifications, SOP acceptance criteria, and GMP requirements
• Review data entered into databases and reports
• Monitor laboratory data quality
• Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs
• Review sample results for scientific soundness, completeness, accurate data representation, and final reported results
• Communicate with laboratory staff to maintain the quality of laboratory documentation
• Deliver clear and concise findings on deficiencies in analytical data or reports
• Escalate significant deficiencies to project leaders or supervisors
• Facilitate discussions with laboratory staff about documentation practices and quality findings
• Advocate for quality and review process changes
• Identify and support process improvement initiatives
• Perform other assigned duties

Requirements

• Must be legally authorized to work in the United States without sponsorship
• Must pass a comprehensive background check, including drug screening
• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification
• 2+ years of comparable experience, or equivalent combination of education, training, and experience
• Previous experience with formal data review in a GMP laboratory strongly preferred
• Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP
• Thorough knowledge of chromatography may be required
• Strong technical knowledge of laboratory procedures, methodology, and standards
• Strong verbal and written communication skills
• Strong attention to detail
• Ability to balance time and remain focused on work to meet goals
• Ability to train staff on basic review techniques
• Ability to independently review laboratory reports and analytical methods
• Ability to handle multiple and changing priorities
• Ability to provide clear and concise feedback and/or documentation of results
• Ability to work in a collaborative team environment
• Ability to work efficiently in a remote capacity
• Ability to communicate, receive, and understand information and ideas with diverse groups of people
• Ability to work upright and stationary and/or standing for typical working hours
• Ability to lift and move objects up to 25 pounds
• Ability to work in non-traditional work environments
• Ability to use and learn standard office equipment and technology proficiently
• Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities

Core Competencies

Demonstrates strong analytical skills in reviewing laboratory data for compliance with SOPs, GMP, and GLP standards, while effectively communicating findings and advocating for quality improvements. Possesses the ability to train staff and manage multiple priorities in a collaborative team environment.

Highest-signal resume keywords

• GMP Laboratory Experience
• Chromatography Knowledge
• SOP Compliance
• Analytical Data Review
• Strong Communication Skills

ATS Optimization Keywords

Hard Skills

• Analytical Analysis
• Laboratory Procedures
• Data Review
• Methodology Evaluation
• Quality Control
• Chromatography
• GMP Knowledge
• GLP Knowledge
• Documentation Practices
• Process Improvement

Soft Skills

• Attention to Detail
• Time Management
• Collaboration
• Feedback Communication
• Adaptability

Industry Keywords

• Pharmaceutical Compounds
• Biopharmaceutical Compounds
• Biological Matrices
• Federal Regulations
• SOP Acceptance Criteria

Tools & Technologies

• Laboratory Equipment
• Standard Office Equipment
• Data Management Software