Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Job Description The Role
In this role, you will support QC Labs with review of test records.
Heres What Youll Do
Heres What Youll Need (Minimum Qualifications)
Heres What Youll Bring to the Table (Preferred Qualifications)
Sunday-Wednesday Second Shift
QC Data Reviewer
Posted: 07/25/2023
2023-07-25
2024-07-11
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 544696
Is job remote?: No
Country: United States
Job Description
Job Description The Role
In this role, you will support QC Labs with review of test records.
Heres What Youll Do
- Review executed QC test records for product release and environmental monitoring.
- Additional duties may be assigned
Heres What Youll Need (Minimum Qualifications)
- BA or BS degree in Biology, Microbiology or similar field
- 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
- Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
- Previous experience managing quality records such as change controls, deviations, and lab investigations
Heres What Youll Bring to the Table (Preferred Qualifications)
- In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
- Experience with rapid microbiological methods
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
Sunday-Wednesday Second Shift
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