QC Data Reviewer
West Chester, OH 45071
$39 per hour (weekly pay)
6 Month Contract (potential for extension)
As the QC Data Reviewer
, you will review QC laboratory documentation and analytical data generated for various samples to in-process, finished product, stability, raw material, cleaning verification/validation, and development and validation samples. In this role you will participate in laboratory investigations that are related to QC processes or data as well as supports validation, method development and transfer activities. Responsibilities:
- Conduct GMP review of laboratory documentation including review of electronic data in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols.
- Communicate findings to analysts and follow up on corrections.
- Assist in authoring and finalizing departmental SOPs.
- Supports laboratory investigations as needed.
- Provides and follows up on ideas for continuous improvements in laboratory processes.
- BA in chemistry, biology or related field
- Working knowledge of cGXP requirements and a strong familiarity with production operations.
- 3-5 years analytical experience in a pharmaceutical GMP facility using various types of instrumentation (HPLC/GC required, including proficiency with chromatography software)
- Proficient in math, laboratory and computer skills. Understand basic statistics and quality control terminology.
- Working knowledge of laboratory equipment (including HPLC), operations, and safety.
- Good problem-solving skills
- Knowledge of cGMP and FDA regulations
- Knowledge of 21 CFR requirements for electronic recordkeeping and data integrity
- Excellent attention to details
Please submit your resume for consideration!