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Key Responsibilities and Required Skills for Certifying Scientist

💰 $70,000 - $130,000

Quality AssuranceLaboratoryPharmaceutical

🎯 Role Definition

A Certifying Scientist is a quality-focused laboratory professional responsible for final review and formal release (or rejection) of test data, certificates of analysis (CoA), and product batches in compliance with cGMP/GLP/GxP and internal SOPs. The role combines deep technical expertise in analytical or microbiological testing, rigorous document control, trend and stability oversight, and regulatory knowledge to ensure safe, effective, and compliant product release. Ideal candidates demonstrate strong investigative abilities, proficiency in LIMS and electronic systems, and experience collaborating with cross-functional teams including QA, Manufacturing, and Regulatory Affairs.

📈 Career Progression

Typical Career Path

Entry Point From:

  • QC Analyst / Laboratory Analyst (Analytical or Microbiology)
  • Analytical Chemist / Microbiologist
  • Laboratory Technician with release testing experience

Advancement To:

  • Senior Certifying Scientist / Lead Certifying Scientist
  • Quality Assurance (QA) Manager or QA Release Manager
  • Head of Quality Control / Director of Quality

Lateral Moves:

  • Validation Engineer (equipment/process validation)
  • Regulatory Affairs Specialist
  • Stability Program Manager
  • Technical Project Lead (analytical methods)

Core Responsibilities

Primary Functions

  • Conduct final scientific and regulatory review of analytical or microbiological test data, batch records, and associated supporting documentation to make a disposition decision for product batch release, ensuring full compliance with cGMP, GLP, and internal SOPs.
  • Authorize and sign Certificates of Analysis (CoA) and electronic batch release records after verifying completeness, accuracy, and conformance to specification criteria and approved methods.
  • Perform robust review and trend analysis of quality control testing data, stability study results, and release statistics to identify out-of-specification (OOS) trends, assay drift, or systemic issues requiring escalation.
  • Lead and execute thorough OOS, OOT (out of trend), and CAPA related investigations by reconstructing test history, reviewing raw data, instrument logs, sample custody, and batch-specific documentation; prepare clear root cause analyses and corrective action recommendations.
  • Validate and evaluate method suitability and system suitability data during release review, ensuring chromatographic, spectroscopic, and assay system performance meets predefined acceptance criteria prior to certifying results.
  • Review and approve deviations, change controls, and associated corrective/preventive actions that impact batch disposition or analytical methods, ensuring regulatory sufficiency and timely closure.
  • Maintain compliance with electronic quality systems and LIMS by ensuring sample records, instrument calibrations, maintenance logs, and chain-of-custody documentation are complete and audit-ready.
  • Oversee and contribute to stability program reviews, providing scientific interpretation and certification of stability data for shelf-life extension, product labeling, and regulatory submissions.
  • Provide technical leadership in cross-functional quality reviews with Manufacturing, Supply Chain, and Regulatory Affairs for product hold/release decisions during investigations, recalls, or regulatory inspections.
  • Ensure method transfer packages and analytical protocols are reviewed for completeness and compliance when new methods are implemented or when technology transfers occur between sites or contract laboratories.
  • Support laboratory readiness for internal and external audits and inspections by preparing documentation, answering technical queries, and executing corrective actions to resolve audit findings.
  • Mentor and train junior scientists and QC analysts on data review expectations, regulatory requirements, SOP adherence, and best practices for data integrity and scientific certification.
  • Interpret complex analytical data from HPLC, GC, LC-MS, GC-MS, UV/Vis, FTIR, titration, wet chemistry, dissolution, and microbiology assays to make a scientifically defensible release decision.
  • Evaluate out-of-specification microbial contaminant investigations in sterile and non-sterile environments, including environmental monitoring review, aseptic processing controls, and sterility test evaluation.
  • Collaborate with method development teams and QA to support method validation/verification activities and to ensure validated methods remain in a state of control for routine release.
  • Review lot-specific manufacturing records and in-process control results to confirm consistency between production data and final analytical testing prior to certifying release.
  • Communicate disposition decisions, non-conformances, and product holds effectively to cross-functional stakeholders and senior leadership with clear rationale and recommended mitigations.
  • Maintain and update certification checklists, release matrices, and SOPs to reflect current regulatory expectations, business needs, and best practices for batch release and data governance.
  • Execute risk assessments related to release decisions, product quality impact, and supply continuity; propose scientifically justified containment, re-sampling, or re-testing strategies when needed.
  • Serve as a subject matter expert for LIMS configuration, data extraction for release reporting, and electronic signatory workflows supporting audit trail integrity and electronic records compliance.
  • Lead investigations related to analytical instrument failures, qualification issues, or calibration lapses that may impact certified results; coordinate instrument requalification and re-verification as required.
  • Prepare and deliver technical summaries and release rationales for regulatory submissions, customer queries, and Supplier Quality interactions when certifying contract-manufactured or third-party tested lots.
  • Maintain up-to-date knowledge of global regulatory expectations (FDA, EMA, ICH) and industry guidance relevant to batch release, analytical testing, and product certification.
  • Drive continuous improvement initiatives within QC and release processes to reduce release cycle time, improve first-pass yield, and enhance data quality controls.
  • Ensure proper handling, storage, and disposition of retained samples, stability samples, and reference standards used during certification and investigations.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.
  • Assist in cross-site harmonization efforts for release criteria, release timeframes, and certification documentation standards.
  • Participate in supplier quality reviews and lab qualification activities for contract testing to ensure outsourced data meets release-ready standards.
  • Provide input to regulatory filings and responses to Health Authority inquiries related to batch release and quality control data.
  • Support continuous training programs for GxP awareness, data integrity, and release procedures across QC laboratories.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep working knowledge of cGMP, GLP, GxP regulations and the scientific standards required for batch release, Certificates of Analysis, and documentation control.
  • Experience performing scientific review and sign-off of CoAs, batch records, stability data and release-related documents.
  • Proficient in LIMS, ELN (electronic lab notebook), and e-signature systems (e.g., LabWare, Benchling, TrackWise, MasterControl) with experience troubleshooting data integrity and audit trails.
  • Strong analytical instrumentation skills: HPLC, GC, LC-MS/MS, UV-Vis, FTIR, TOC, Karl Fischer, dissolution systems, spectrophotometers, and routine wet chemistry methods.
  • Microbiology testing expertise (sterility, bioburden, endotoxin, environmental monitoring) for sterile and non-sterile products where applicable.
  • Experience leading and documenting OOS/OOT/CAPA investigations, root cause analysis (RCA), and execution of corrective/preventive actions.
  • Knowledge of method validation/verification principles, stability protocol review, and statistical analysis of assay and stability data.
  • Proficient with quality systems: document control, deviation management, change control, audit management, and supplier quality interactions.
  • Familiarity with regulatory inspection readiness and preparing technical responses for FDA, EMA, and other regulatory authorities.
  • Solid data analysis skills using Excel (pivot tables, trend analysis), statistical software and ability to interpret complex datasets for decision-making.
  • Experience with change control and risk assessment tools (FMEA, risk matrices) applied to release decisions and laboratory operations.
  • Understanding of sample management, chain of custody, retention sampling, and cold-chain requirements where applicable.

Soft Skills

  • Exceptional attention to detail and a methodical approach to document and data review that ensures defensible certification decisions.
  • Strong verbal and written communication skills, capable of preparing concise release rationales and presenting technical conclusions to technical and non-technical stakeholders.
  • Sound scientific judgment and decisive problem-solving skills in high-pressure situations impacting product release or supply continuity.
  • Collaborative mindset with proven ability to work cross-functionally across QA, Manufacturing, Regulatory Affairs, and Supply Chain.
  • Time management and organizational skills to manage multiple release priorities and regulatory commitments concurrently.
  • Mentoring and coaching ability to elevate QC analyst capabilities and foster a culture of continuous improvement.
  • Integrity and accountability in upholding data integrity principles and regulatory obligations.
  • Adaptability to evolving regulatory expectations, new technologies, and process improvement initiatives.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, or related life sciences field.

Preferred Education:

  • Master’s degree or PhD in Analytical Chemistry, Microbiology, Pharmaceutical Sciences, or related discipline preferred for complex biologics or advanced analytical responsibilities.

Relevant Fields of Study:

  • Analytical Chemistry
  • Microbiology
  • Biochemistry
  • Pharmaceutical Sciences
  • Chemical Engineering (with laboratory experience)

Experience Requirements

Typical Experience Range:

  • 3–8 years of progressive laboratory experience in QC, analytical development, or microbiology, with at least 2 years in release/certification activities or quality roles in regulated environments.

Preferred:

  • 5+ years certifying or performing scientific release in pharmaceutical, biotechnology, or medical device companies; demonstrated experience with regulatory inspections and leading investigations.
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