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Compendial Scientist Jobs in Ohio (NOW HIRING)

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QC Scientist I

Cincinnati, OH · On-site

$20 - $24/hr

The QC Scientist I performs routine analyses and documentation of any of the following: Raw ... internally developed and compendial test methods. Executes validated test methods for ...

The Pharmaceutical Scientist I is responsible for performing routine analyses and documentation of ... compendial test methods. * Execute validated test methods for pharmaceutical raw materials to ...

Senior Analyst, QC Microbiology

West Chester, OH · On-site

$22.75 - $30.50/hr

... serve scientific discovery, and reach those in need. For more information, please visit www ... Actively support and/or lead the implementation of compendial changes for raw materials, in-process ...

... compendial and in-house). -Work collaboratively in a team environment to develop and maintain a ... About Actalent Actalent is a global leader in engineering and sciences services and talent ...

Compendial Scientist information

What is the difference between Compendial Scientist vs Quality Control Analyst?

AspectCompendial ScientistQuality Control Analyst
Required credentialsBachelor's degree in life sciences, certifications in GMP/GLPBachelor's degree in sciences, certifications in GMP/GLP
Work environmentLaboratories, regulatory agencies, pharmaceutical companiesLaboratories, pharmaceutical manufacturing facilities
Employer and industry usageUsed in regulatory compliance, ensuring products meet pharmacopeial standardsUsed 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 the key skills and qualifications needed to thrive as a Compendial Scientist, and why are they important?

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 are Compendial Scientists?

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 cities in Ohio are hiring for Compendial Scientist jobs? Cities in Ohio with the most Compendial Scientist job openings:
QC Scientist I

QC Scientist I

Staffing

Cincinnati, OH • On-site

$20 - $24/hr

Contractor

Posted 5 days ago

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Job description

Title: QC Scientist I
Location: Cincinnati OH 45237 
Duration: 12 months
 

First shift.
Can start from between 6am to 9am.
OT is asked but is rare.

Potential to convert depending on the worker. 

General Information

Job Description: 

Summary of position:
The QC Scientist I performs routine analyses and documentation of any of the following:
Raw Materials, In-Process samples, Calibrations, or projects within the QC Chemistry Laboratory, in a manner consistent with established standards. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.

Essential Functions:
Conducts routine chemical and physical testing of raw materials by internally developed and compendial test methods. Executes validated test methods for pharmaceutical raw materials for strength, impurities, identity, and characteristics by utilizing HPLC, GC, spectroscopy, and/or traditional wet chemical testing. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. Performs daily instrument calibrations / verifications as required. Clearly and accurately communicates the results of work by accurate documentation of the testing/analysis and acquired results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Prepares test solutions including medias and mobile phases. Cleans and maintains work area and instrumentation. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the vital compliance status required by company and facility standards.

Education:
Bachelor’s degree in physical science, preferably in Chemistry is a must. 

Experience:
Typically requires no previous related experience. Experience performing chemical tests with chromatographic, spectroscopic, other analytical techniques or Compendial testing highly preferred.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.

Proficiencies:
Good knowledge and understanding of basic instrumental technologies and qualitative and quantitative chemical analyses. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Follow all company policies, SOPs, cGMPs, work instructions, methods and analyst’s guidelines. Demonstrates efficiency by multitasking and scheduling time to meet required workload. Actively seek additional assignments when testing in primary area of responsibility is completed. Takes initiative and independently pursues training and/or learning opportunities to improve personal skills and share skills with other team members. Proven interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Ability to work in a fast-paced environment. 

Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.