QA Technical Reviewer
Department: Quality Assurance
Job Title: Technical Reviewer
FLSA Status: Exempt
Reports To: Varies
1. Role Purpose:
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.
2. Key Duties and Responsibilities:
- Daily activities include review of documentation generated during method development, method validation, stability testing, routine testing and other analyses.
- The individual will interface with their supervisor, the 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.
- A KRA is a Key Result Area that is aligned with the department’s objectives. It is a core responsibility for the candidate that is linked to a specific measure of achievement called a KPI (Key Performance Indicator). KPI measurements will be used to judge the candidate performance during their annual review, as a measure of their ability to perform their core duties optimally.
- Review and approve Analytical Protocols, Analytical Reports and other documents
3. Typical Supervisory Responsibility:
N/A
4. Education & Experience:
Education Requirement
Bachelor’s degree in Chemistry or a related field preferred
Specialization (If any)
N/A
Experience Requirement
N/A
5. Technical competencies/Certifications/Licenses:
Technical competencies
- 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 plus
- Preferred Industry/Former Companies: Pharmaceutical or a related field
- Takes initiative on assignments and day to day responsibilities
- Keen observational skills and attention to detail
- Proficient in personal and communication skills
- Organizational and planning skills
- Continuous working knowledge on applicable cGMP guidelines
- Continuous working knowledge of applicable DEA regulations
6. Physical Demand and Work environment:
Physical 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.
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.