Welcome page Returning Candidate? Log back in! Data Reviewer Location : Location US-MD-Rockville ID 2024-5095 Category Research and Science Type Full Time - Permanent Overview

Quality Control Data Reviewer

Responsibilities

Corporate Responsibilities:

Adherence to laboratory health and safetyAdherence to Standard Operating Procedures (SOPs)Adherence to applicable company policies and guidelines Adherence to federal and/or local regulations as applicable
 

Responsibilities and Duties

Corporate

·       Interact with the community and employees.

·       Support and participate in other company initiatives as directed by senior management.

·       Coordinate all quality control-related activities.

·       Perform other duties as assigned.
 

General

·       Enter data into databases.

·       Follow SOPs and other applicable laboratory or company procedures.

·       Maintain confidential information.
 

 

Specific

·       Understand biotherapeutic instrumental techniques including but not limited to Immunoassays (e.g., ELISA, MSD, Luminex, flow cytometry, genomic analysis, and cell-based assays). Troubleshoot and resolve instrumentation issues with support of outside technical resources.

·       Editing, review and approval of biotherapeutic data to specific SOP and standard requirements, quality control electronic records, protocols, method validations, stability studies as well as technical, summary, and analytical reports.

·       Ability to use a personal computer to write reports and verify calculations.

·       Ability to adhere to all safety regulations and procedures.

·       Ability to interact with scientific staff at all levels and work collaboratively with multiple groups.  

·       Conduct quality control tests when requested and document quality investigations.

·       Provide technical support and train members of the quality control team.

·       Perform statistical and analytical analysis of experiments to review QC data and trends and determine if any corrective actions are required.

·       Troubleshoot and resolve assay issues.

·       Review and summarize results to support the release of raw data and support internal quality review meetings.

·       Manage vendors and technicians that come onsite to maintain laboratory equipment.

·       Schedule and provide approval for sample receipt, storage and testing procedures.  
 

Performance requirements

 

General

·       Ability to read, write, speak, and understand English.

 

Physical Activity

·       Moderate physical activity.

·       This position will require frequent walking, sitting and/or standing for extended periods of time, reaching while standing, gripping, and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day).

·       Able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required.

·       Ability to read and understand applicable materials.

·       Manual dexterity to operate calculator/computer.

·       Able to read and interpret test results and instrument specifications.
 

Working Conditions

·       Work is normally performed in a typical interior office work or laboratory environment.

·       Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include use of protective equipment.

·       The noise level is usually moderate.

·       Due to exposure to hazardous biological material (which may include HIV positive specimens), immunization to Hepatitis B and/or other diseases may be a requirement.

Qualifications

Education and experience

·       B.S in a scientific discipline (e.g., biology, biochemistry, bioengineering or related discipline), or

·       At least 2 years of direct work experience in a scientific environment (regulated setting preferred – GLP laboratory environment).

·       Equivalent combination of related education and required work experience will be considered.

·       Technical leadership in and a good understanding of quality control function.

Skills and Abilities

·       Ability to comprehend and apply applicable government regulations (including FDA 21 CFR part 58 (GLPs) and FDA 21 CFR part 11).

·       Familiar with Microsoft Office Excel and capable of learning new software packages.

·       Excellent organizational skills.

·       Excellent and effective oral and written communication skills. A team player.

·       Capable of understanding scientific requirements for FDA GLP regulated laboratories.

·       Capable of verifying accuracy and precision of study data Familiar with Microsoft Office Excel and capable of learning new software packages.

·       Capable of paying attention to detail and managing multiple priorities involving tight timelines at a high level of productivity.

·       Ability to apply analytical and research skills.

·       Demonstrate lab equipment knowledge and program understanding.

 

 

 

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience.  The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

 

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.  Join us in embracing research and science to impact the health and well-being of people all over the world.

 

Inotiv has been named a 2023 Top Workplace!

Salary will be commensurate with experience and responsibilities, paying upto $63,600. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

 

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

 

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