QC Senior Scientific Reviewer

Merck•Carlsbad, CA

About The Position

The Quality Control Scientific Reviewer provides independent, data-driven review and oversight across in-process, release, and stability testing. The role will include technical writing of methods, protocols, reports, and investigations. This role integrates data reviews and trend analysis, and document quality assurance to support manufacturing, qualification, and lifecycle management of methods, materials, and products. Perform data reviews/analyses, track metrics, and identify trends to inform release decisions, stability conclusions, and risk assessments. Oversee drafting, reviewing, and approval of technical documents (protocols, SOPs, URS, trend reports, change controls, CAPAs, investigations) for regulatory readiness. Facilitate collaborative approval workflows for documents, coordinating with third parties as needed. Produce and quality-check reports, trend analyses, and investigative summaries; maintain traceability and audit readiness. Conduct USP/JP/EP/Eurachem compliance reviews; support regulatory submissions and internal audits. Lead CAPA generation and closure documentation, Out of Specifications, Out of Trend, GCC, and deviations; investigate with root-cause analysis and preventive actions. Manage stability programs and studies (forecasts, scheduling, timelines); provide stability/testing planning (protocols, strategies, data interpretation). Engage cross-functionally on data-driven decisions; support raw material qualification; compile GMP data for COA; serve as client-facing scientific reviewer/writer.

Requirements

Bachelor’s Degree in Chemistry, Analytical Science, or related Life Science Discipline and 9+ years in GLP/GMP analytical environments in Quality Control or Process and Development.
OR Master’s Degree in Chemistry, Analytical Science, or related Life Science Discipline and 7+ years in GLP/GMP analytical environments in Quality Control or Process and Development.
Proficiency in analytical techniques (e.g., ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays).
Method validation/transfer.
Data trending and statistics.
Instrument maintenance.
Basic programming or data analysis tools a plus.
Knowledge of cGMP, ICH guidelines, and QA/QC systems.
Experience with regulatory submissions and deviations/CAPAs.
Excellent scientific communication (written and oral).
Problem-solving skills.
Collaboration skills.
Adaptability.
Mentoring ability.

Nice To Haves

Detail-driven, data-focused professional who conducts independent review and oversight of stability, testing, and technical documentation to ensure scientific rigor, regulatory compliance, and timely decision-making.
Strong data interpretation, method monitoring, and documentation quality assurance to support material and product lifecycle activities.
Experience with or understanding of analytical methods such as UHPLC, CE-SDS, ELISA, PCR (ddPCr & qPCR), and Cell Culture.
Academic or industry-based background in Virology.
Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
Biologics/Virology background.
Experience with microbial testing, QA release testing, and GMP documentation.

Responsibilities

Provides independent, data-driven review and oversight across in-process, release, and stability testing.
Technical writing of methods, protocols, reports, and investigations.
Integrates data reviews and trend analysis, and document quality assurance to support manufacturing, qualification, and lifecycle management of methods, materials, and products.
Performs data reviews/analyses, tracks metrics, and identifies trends to inform release decisions, stability conclusions, and risk assessments.
Oversees drafting, reviewing, and approval of technical documents (protocols, SOPs, URS, trend reports, change controls, CAPAs, investigations) for regulatory readiness.
Facilitates collaborative approval workflows for documents, coordinating with third parties as needed.
Produces and quality-checks reports, trend analyses, and investigative summaries; maintains traceability and audit readiness.
Conducts USP/JP/EP/Eurachem compliance reviews; supports regulatory submissions and internal audits.
Leads CAPA generation and closure documentation, Out of Specifications, Out of Trend, GCC, and deviations; investigates with root-cause analysis and preventive actions.
Manages stability programs and studies (forecasts, scheduling, timelines); provides stability/testing planning (protocols, strategies, data interpretation).
Engages cross-functionally on data-driven decisions; supports raw material qualification; compiles GMP data for COA; serves as client-facing scientific reviewer/writer.