Quality Auditor II
Rockville, MD
Job Id:
130346
Job Category:
Job Location:
Rockville, MD
Security Clearance:
None
Business Unit:
Piper Companies
Division:
Piper Clinical Solutions
Position Owner:
Emily Mills
- Piper Companies is currently looking for an experienced Quality Assurance Auditor in Rockville, MD in a hybrid role.
- Responsibilities for the Quality Assurance Auditor include:
- Prepare, execute and follow-up of internal and external vendors and supplier audits
- Initiate new SOPs and/or revise existing SOPs as needed
- Initiation, tracking and closure of quality records like Deviations, Change Controls, CAPAs and Out of Specification (OOS) records
- Conduct thorough technical reviews of manufacturing batch records to ensure compliance with established procedures, regulations, and quality standards
- Performs QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real time
- Qualifications for the Quality Assurance Auditor include:
- 2+ years’ of relevant experience in pharmaceutical, biotechnology or biopharmaceutical industry in a GLP environment
- Experience with Batch record review, out of specification results, and CAPA investigations
- Knowledge of electronic documentation Quality Management Systems a plus
- Bachelor’s degree in life sciences, preferably biology or chemistry
- Compensation for the Quality Assurance Auditor include:
- · Salary Range is $70,000 – $80,000 based on experience
- Keywords
- Quality Control Analyst, Oncology, Flow Cytometry, Elisa, PCR, Cell Based Assays, Batch Release, Sample testing, maintenance, calibration, tech transfer, authoring protocols, assays, environmental monitoring
- #LI-EM2
- #LI-HYBRID