Pharmaceutical company, one of the nation’s leading manufacturer of OTC pharmaceuticals, located in New Brunswick, NJ is in need of a Quality Auditor / Analytical Data Reviewer. This is a Direct Hire opportunity.
Compensation: $52,500-$74,000 TBD
Salary + up to 10% annual bonus.
AUDITOR, OFFICE OF DATA RELIABILITY
The Auditor, Office of Data Reliability (ODR) is accountable for review of data (submission/pre-submission data that goes to the FDA) critically per current in-house and compendia requirements to ensure completeness and accuracy of all data.
Ensure compliance with cGLP/cGMP’s.
Adherence to the Safety and Health Program and associated plans.
Educate QC analytical chemists to improved analytical data documentation and reporting.
Strictly adhere to ODR audit checklist, specification and test procedures while reviewing the documents given by concerned chemist, supervisor or Regulatory Affairs department.
Complete audit tasks within specified time frame without compromising quality of audit.
Highlight any deficiency in reporting the documents given for review.
Inform concerned manager and Chief Data Reliability Officer (CDRO) immediately of any critical data integrity or issue of irregularity.
Audit client manufacturing and quality units within the ODR checklist on a routine basis and report any deficiencies directly to the department head.
Continuously improve the documentation system to increase efficiency and GLP compliance.
Report all audit findings in the ODR audit reports and highlights as well as report CDRO certification of any critical deficiencies.
Any other responsibilities which are deemed necessary as assigned by the department head.
Ability to work at any U.S. location and may be required to travel to India.
Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field.
A Master of Science (M.S.) in Chemistry, Pharmacy, Biochemistry or related field is preferred.
Five (5) to seven (7) years of experience in a pharmaceutical company within Quality Assurance or Quality Control.
Two (2) to three (3) years of experience in reviewing analytical data.
Knowledge of QC Laboratory test procedures, cGMP, cGLP, ICH and US FDA guidelines, raw material analysis, method validation guidelines, analytical method transfer, finished products and stability testing procedures.
Ability to review of standard operating procedures, test procedures, validation protocols.
Ability to review of batch records.
Proficient in MS Office applications (Word, Excel).
Ability to work in manufacturing environment.
Ability to monitor, coordinate and prioritize work in an effective and efficient manner.
Must be a self-motivated, proactive team member with positive interaction with colleagues and stakeholders to ensure t work ethics, teamwork, and discipline.
Manage with quality projects and timelines.
Must have excellent interpersonal and communication skills (verbal and written).
Conduct oneself in a professional manner in alignment with corporate values.
Ability to work and interact successfully in a global, diverse and dynamic environment.
Candidates interested must submit their cover letter, resume and salary expectations for this position to Jennifer : Jcremonesi@volt.com
Volt has a talented and optimistic staffing team focused on the quality of your career.
Volt has over 60 years of staffing experience. We work with many of the Fortune 500 and 1000 companies to provide workforce solutions. We offer many direct hire
full-time positions as well as many contingent/temporary positions.
Volt is an Equal Opportunity Employer
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