Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Target PR Range: 35-45/hr
*Depending one experience
Responsibilities:
• Perform data and document review to ensure data integrity and compliance of laboratory reports including but not limited to Microbiology and Analytical data, method validation, stability and technical reports.
• Draft technical documents including but not limited to OOS and non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work Instructions.
• Oversee critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules. Initiate equipment change control and assist with coordination of set up and qualification activities for new assets. Assist with OOT investigations in the Asset Management System.
Skills:
• Experienced in GMP regulated drug development environment.
• Knowledgeable of typical data, data types and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC compliance requirements for Select Agent Toxin program preferred.
Experience:
• Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience. Knowledge of GMP, ISO, and FDA regulations a plus. Familiar with process and test method validations. Excellent communication skills. Ability to perform under pressure to meet project deadlines.
Scientist II
Posted: 01/16/2025
2025-01-16
2025-02-22
Employment Type:
Contract
Job Category: Scientific
Job Number: 617023
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 35-45/hr
*Depending one experience
Responsibilities:
• Perform data and document review to ensure data integrity and compliance of laboratory reports including but not limited to Microbiology and Analytical data, method validation, stability and technical reports.
• Draft technical documents including but not limited to OOS and non-conformance quarterly trend reports, equipment Out of Tolerance investigations, Standard Operating Procedures and Work Instructions.
• Oversee critical laboratory instruments and equipment to ensure compliance with qualification, maintenance and calibration schedules. Initiate equipment change control and assist with coordination of set up and qualification activities for new assets. Assist with OOT investigations in the Asset Management System.
Skills:
• Experienced in GMP regulated drug development environment.
• Knowledgeable of typical data, data types and documentation that are produced in CMC during clinical development of pharmaceutical and biological drugs (e.g manufacturing and QC of clinical trial material, stability testing, test method transfer).
• Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC compliance requirements for Select Agent Toxin program preferred.
Experience:
• Must possess a BS in molecular biology, biochemistry, or related field with at least three years of relevant experience. Knowledge of GMP, ISO, and FDA regulations a plus. Familiar with process and test method validations. Excellent communication skills. Ability to perform under pressure to meet project deadlines.
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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
