Overview
Department : Quality Assurance
Job Title : Technical Reviewer
FLSA Status : Exempt
Reports To : Varies
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Responsibilities
- The QA Technical Reviewer will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards.
- Daily activities include review of documentation generated during method development, method validation, stability testing, routine testing and other analyses.
- Interface with supervisor, analytical groups and QA on a daily basis.
- Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness.
- Provide feedback from reviews to analysts and supervisor and ensure necessary action are taken to correct or prevent error.
- Review data using a systematic approach to ensure compliance with procedures and specifications.
- Review and audit projects as required. Perform other duties assigned by supervisor as needed.
- Review and approve Analytical Protocols, Analytical Reports and other documents.
- Typical Supervisory Responsibility : N / A
Education & Experience
Education Requirement : Bachelor's degree in Chemistry or a related field preferredSpecialization (If any) : N / AExperience Requirement : N / ATechnical competencies / Certifications / Licenses
GMP laboratory experience : minimum 1-year experience with instrumental techniques a plus; 2+ years of experience in a GMP lab using HPLC, GC, and / or related analytical techniques. QC data review experience a plusPreferred Industry / Former Companies : Pharmaceutical or a related fieldTakes initiative on assignments and day-to-day responsibilitiesKeen observational skills and attention to detailProficient in personal and communication skillsOrganizational and planning skillsContinuous working knowledge on applicable cGMP guidelinesContinuous working knowledge of applicable DEA regulationsPhysical Demands
While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and / or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.
Equal Opportunity
KVK Tech is an affirmative action / equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status. We encourage you to apply if you feel that you are a match! We look forward to hearing from you.
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