Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.Job Responsibilities
Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.Job Responsibilities
QC Microbiologist
Seminole, FL · On-site
$85K - $87K/yr
Bachelor's degree in microbiology, Biology, or a closely related life science discipline ... Advanced understanding of aseptic processing, cleanroom behaviors, and compendial requirements (USP ...
Quick apply
QC Microbiologist
Seminole, FL · On-site
$85K - $87K/yr
Bachelor's degree in microbiology, Biology, or a closely related life science discipline ... Advanced understanding of aseptic processing, cleanroom behaviors, and compendial requirements (USP ...
Manager, QCA
Fort Lauderdale, FL · On-site
... technical and scientific experience in the pharmaceutical industry to ensure adherence to ... compendial requirements and their application. · Strong attention to detail, observation ...
New
Quick apply
Manager, QCA
Fort Lauderdale, FL · On-site
... technical and scientific experience in the pharmaceutical industry to ensure adherence to ... compendial requirements and their application. · Strong attention to detail, observation ...
New
Compendial Scientist information
What is a compendial scientist?
Compendial Scientists are professionals who specialize in ensuring that pharmaceutical products comply with standards set by official compendia, such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.). They review, interpret, and implement compendial requirements into a company's quality control processes and documentation. Their work often involves collaborating with regulatory agencies, staying current with changes in compendial standards, and participating in the development or revision of monographs and methods. Compendial Scientists play a critical role in maintaining product quality, safety, and regulatory compliance in the pharmaceutical industry.
What are the key skills and qualifications needed to thrive as a compendial scientist?
To thrive as a Compendial Scientist, you need a strong background in analytical chemistry, regulatory compliance, and scientific documentation, typically supported by a degree in chemistry, pharmacy, or a related field. Familiarity with laboratory instrumentation (such as HPLC, GC, and spectroscopy), compendial standards (USP, EP, JP), and quality management systems is essential. Attention to detail, critical thinking, and effective communication help ensure accuracy and clear documentation of results. These skills and qualities are crucial to maintain product quality, meet regulatory requirements, and support successful audits in the pharmaceutical industry.
What are some common challenges faced by compendial scientists when ensuring compliance with evolving pharmacopeial standards?
Compendial Scientists often encounter the challenge of staying current with frequently updated pharmacopeial standards and ensuring that laboratory methods and documentation remain fully compliant. This requires constant monitoring of regulatory changes, rapid adaptation of procedures, and effective collaboration with quality assurance, regulatory affairs, and analytical development teams. Timely communication and robust project management skills are essential to implement changes without disrupting ongoing operations. Proactively engaging in cross-functional meetings and training sessions can help address these challenges and ensure seamless compliance.
What is the difference between Compendial Scientist vs Quality Control Analyst?
| Aspect | Compendial Scientist | Quality Control Analyst |
|---|---|---|
| Required credentials | Bachelor's degree in life sciences, certifications in GMP/GLP | Bachelor's degree in sciences, certifications in GMP/GLP |
| Work environment | Laboratories, regulatory agencies, pharmaceutical companies | Laboratories, pharmaceutical manufacturing facilities |
| Employer and industry usage | Used in regulatory compliance, ensuring products meet pharmacopeial standards | Used in testing and analyzing raw materials and finished products |
Compendial Scientists focus on ensuring products meet pharmacopeial standards and regulations, often working on documentation and compliance. Quality Control Analysts primarily perform testing and analysis of samples to verify product quality. Both roles require similar credentials and work environments, but their core responsibilities differ in scope and focus.
What are popular job titles related to Compendial Scientist jobs in Florida?
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What job categories do people searching Compendial Scientist jobs in Florida look for?
The top searched job categories for Compendial Scientist jobs in Florida are:
What cities in Florida are hiring for Compendial Scientist jobs?
Cities in Florida with the most Compendial Scientist job openings:
Job description
Job Summary: Laboratory position which involves development and validation of analytical methodology in support of the research projects involving testing of pharmaceutical components and/or drug products. Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.Job Responsibilities
- Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
- General knowledge of cGMP and FDA requirements.
- Perform stability testing for GMP and R&D finished products
- Conduct analytical testing of API, excipients and components following compedial and validated methods
- Perform analytical method validation and method transfer with a minimum supervision.
- Follow company’s SOPs, STPS and comply with safety regulations.
- Maintain detailed record of experiments in the laboratory notebook.
- Timely communicate to supervisor(s) the obtained data and any issues aroused during testing
- Ability to analyze and interpret the analytical data under minimum supervision.
- Interpret specifications, standard operating procedures, and standard testing procedures.
- Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under the supervision.
- Works as a member of a team to achieve all outcomes
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
- All other relevant duties as assigned
Job Requirements
- Education
- Bachelor’s degree (B.S.) in chemistry or related field
- Master’s degree (M.S.)
- Knowledge, Skills and Abilities
- General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, correlation techniques
- Analytical chemistry and common instrumentation
- General understanding of HPLC, GC, Drug Release, UV, IR, Titration.
- Using common computer software and analytical applications programs.
- Writing and interaction in English
- Experience
- At least two (2) to five (5) years experience in pharmaceutical laboratory (B.S)
- At least zero (0) to three (3) years experience (M.S.)