Nonclinical Quality Control Reviewer II

Payrate: $ 58.00 - $ 60.20/hr.

Team overview:

• A typical day involves working through a QC checklist, identifying potential issues, and working with the document authors and scientific staff to resolve conflicts.

Role description:

• The position is for a QC reviewer for non-clinical documents, supporting the medical writing team.
• The QC reviewer will review raw data from the pharmacology lab (data from instruments and electronic data notebooks).
• Responsibilities include reviewing reports, checking data accuracy, and ensuring compliance with regulatory filing requirements.
• The QC reviewer will work closely with the medical writers and the team in Lexington, MA.
• The role is primarily workload-driven, merging the need for raw data QC with regulatory document QC.
• The work situation in Boulder is a minimum of three days a week in the office, but candidates can be on-site five days a week if they prefer.
• Top 3 required Technical Skills:
• Experience with QC of non-clinical documents
• Proficiency with bioanalytical assays and biomarker assays, including familiarity with chromatography and related instrument outputs.
• Knowledge of pharmacology test systems and software such as GraphPad Prism, RT-PCR analysis, mass spec, and HPLC programs.

Soft Skills:

• Demonstrated ability to meticulously review documents and data, ensuring accuracy and compliance with regulatory requirements, as noted by Amber Beaudry.
• Possess strong analytical capabilities to identify and resolve potential issues or discrepancies within non-clinical documents and data.
• Effective communication and collaboration skills to work closely with medical writers, scientific staff, and cross-functional teams to resolve conflicts and ensure the quality of regulatory submissions.

Ideal candidate profile:

• Ideal candidates should have experience with QC of non-clinical documents and familiarity with pharmacology aspects (bioanalytical, pharmacokinetics, pharmacology test systems, and software).
• Detail-oriented with strong analytical skills.
• Experience with bioanalytical assays or biomarker assays will be valuable, particularly with outputs from chromatography and other instruments.
• Any writing experience, familiar with QC.
• Candidates with higher education levels (Master's or PhD) will be considered if they are interested in the role.
• An ADME scientist with some data review experience could be a good fit.
• Preferred pharmacology test systems/software include those used for RT-PCR analysis, mass spec, and HPLC.
• Ideal candidate should be experienced in bioanalytical assays and biomarker assays
• Relevant job titles may include roles related to data stewardship, but focusing on qualifications and proficiency with MS Office and analytical software is key.

Pay Transparency:

The typical base pay for this role across the U.S. is: $ 58.00 - $ 60.20 /hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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