FSP - Sr Data Reviewer - Lab Support

About the role

This is a fully remote role supporting our GMP Laboratory in Greenfield, IN. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship.

Responsibilities

• Perform complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness.
• Review development analyses of non-routine projects.
• Performs analytical data review of method qualification, verification, and validations interpreting the data for compliance and technical soundness.
• Reviews routine and non-routine protocol and methods.
• Facilitate conversations with lab staff on best documentation practices and address quality findings.
• Note deficiencies within the analytical data or reports in a clear and concise manner.
• Escalate significant deficiencies to the project leader or supervisor for assessment.
• Train new Data Reviewers and laboratory staff in basic and complex analytical data review.
• Mentor junior data review staff in review process.
• Advocate for quality and review process changes.
• Assist the departmental manager or supervisor in the evaluation of the laboratory Data Review process and assign work to self and others.
• Identify and drive process improvement initiatives.
• Perform other duties as assigned.

Requirements

Must be able to pass a comprehensive background check, which includes a drug screening.

Qualifications

• Bachelor's degree (Life Sciences degree preferred) or equivalent and relevant formal academic / vocational qualification.
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Skills

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
• Thorough knowledge of chromatography may be required.
• Strong technical knowledge of method validation and probable cause evaluation.
• Strong technical knowledge including an understanding 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 and mentor junior data review and lab staff.
• Ability to independently review laboratory reports and analytical methods with minimal oversight.
• Ability to deal with multiple and changing priorities.
• Ability to provide clear and concise feedback and/or documentation of results.
• Ability to work in a collaborative team environment.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Pay

Competitive remuneration.

Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.).