Job Details
Piper Companies is currently seeking a Deviations Management Biochemist for an opportunity in Lansdale, Pennsylvania (PA), to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines.
Responsibilities of the Deviations Management Biochemist
- Provide technical support to project team, ensuring compliance with cGMP, GLPs, CFRs, and international regulations
- Perform data integrity within biochemistry laboratories and drug manufacturing spaces by leading investigations via root cause analysis
- Focus on Endotoxin assays and elevate compliance, assay robustness, and lab performance
- Drive process improvements, execute timely projects, and complete technical documentation
Qualifications of the Deviations Management Biochemist- 2+ years of experience leading major investigations on deviations in a highly regulated pharmaceutical manufacturing (GMP) environment
- Highly proficient in technical writing, protocol development, and documentation
- A biochemistry background with assay experience and analytical chemistry skills including HPLC, UV, wet chem, compendial testing, and ICP analysis is a plus
- Knowledge of method validation and equipment qualification
- Bachelor's/Master's degree in Chemistry or related field
Compensation for the Deviations Management Biochemist- Salary Range : $40 - $48 / hour
- Benefits : Medical, Dental, Vision, 401k match, Paid Holidays, and PTO
Keywords: Investigations, Deviations, Root Cause Analysis, Corrective Actions, Preventive Actions, Project Management, Timely Completion, Stakeholder Communication, Method Validation, Equipment Qualification, Analytical Techniques, HPLC, UV Spectrophotometry, Wet Chemistry, Compendial Testing, ICP Analysis, Pharmaceutical Chemistry, Bachelor's Degree, Master's Degree, Procedural Knowledge, Pharmaceutical Industry, Strong Analytical Skills, Technical Writing, Protocol Development, Documentation, Self-Motivated, Detail-Oriented, Cross-Functional Collaboration, Healthcare, Patient Outcomes, GMP, cGMP, Good Manufacturing Practice, Current Good Manufacturing Practice, Analytical Chemistry, Testing
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