A company in Largo Hiring a 1st shift QA Data Reviewer

Hours: 6:30am - 3:00pm

Pay: $30.00 per hour

The Quality Assurance QC Data Reviewer ensures compliance of all QC data review activities, including review laboratory notebooks, and analytical data generated for various samples. Including but not limited to samples for in-process, finished product, stability, raw material, component, cleaning verification/ validation, and process performance qualifications.

The incumbent is responsible for supporting the company’s Quality Assurance efforts. This includes the performance of area responsibilities necessary to ensure that facility activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with quality objectives.

1. Conduct GMP review of laboratory notebooks and chromatography (including on-line review of electronic data) in a timely manner for compliance with applicable SOPs, test methods, regulations, and protocols.

2. Review various test reports for accuracy, completeness, and compliance with specifications.

3. Reviews data stored on various laboratory instrumentation, such as through Empower 3 system to ensure appropriate closure and accountability of all runs.

4. Communicate findings to analysts and follow up/ facilitate completion of corrections.

5. Complete data review checklists and update tracking tool, such as LabSTS or as applicable.

6. Assist in authoring, reviewing and finalizing departmental SOPs and other methods as needed.

7. Develop and implement tracking mechanisms data review metrics. Report metrics to Quality Council or management as needed.

8. Escalate potential quality issues to Sr. Management as appropriate.

9. Perform all other duties as may be assigned by management

A Bachelor's Degree is required. With degree or focus in Chemistry, Related Science or Engineering is strongly preferred.

An equivalent combination of education, training, and experience may substitute for the following: Prior experience in a pharmaceutical/ FDA regulated laboratory testing environment. Strong emphasis on analytical Chemistry techniques with various types of instrumentation ( HPLC/GC required, including proficiency with chromatography software) is required (3 -5 years). Prior experience in a pharmaceutical/FDA regulated facility or other GMP regulated environment. (3 - 5 years) Knowledge of 21 CFR 210/ 211 requirements for electronic record keeping and data integrity is required (3 - 5 years).

Individual must demonstrate the following: Ability to read, analyze and interpret common scientific and technical documents. Strong written and verbal communication skills. Thorough understanding of compliance requirements and ability to follow detailed written procedures. Ability to handle multiple, at times complex tasks and prioritize and adapt to business needs. Working knowledge in Microsoft Office Suite of programs (Word and Excel is required, and PowerPoint skills are preferred).