Avet Pharmaceuticals Inc. · 1 day ago
QA Auditor I - Temp role
South Brunswick, NJ
Full-time
Onsite
Mid Level
$27/hr - $32/hr
3+ years expAvet Pharmaceuticals Inc. is seeking a QA Auditor I for a temporary onsite position at their East Brunswick, NJ facility. The role involves ensuring compliance with cGMP requirements through the review of quality control data and documentation.
ManufacturingPharmaceutical
No H1B
Responsibilities
Determine whether quality activities and related QC-QA audits and processes comply with the cGMP requirement
Review of all the raw data including chromatograms and certificate of analysis generated during various testing in Quality control lab such as Raw material testing, packaging material testing, in-process testing, stability testing, equipment cleaning samples testing, Process validation samples analytical method validation/verification testing, etc
Review of protocols, raw data, and Reports related to instrument calibration and qualification
Review of raw data and Reports related to working standard qualification
Review the audit trails and ensure proper integration on Empower software as a basis of soft version review prior to the release of any certificate of analysis
Release of all the data on the SAP system and performing user decisions were ever required (example raw material/packaging material)
Review of Deviation and out of specification related raw data and respective reports
Review of daily calibrations like an oven, balance, pH meter, etc
Issuance of quality documents like Protocols, certificate of analysis, Laboratory Notebooks etc to QC
Performing Sample log in for all samples that are received in QC for testing
Preserving all the quality document related to testing and submitting to QA department for Archival as a part of document control
Provide support for Operations, Regulatory affairs, R & D and Quality Control objectives
Review of data and report related to Analytical method validation as required
The person will record the analytical package received from QC for auditing
The person will review the raw data received including not limited to data package, lab notebook, protocol pages etc. from QC related to testing and calibration
He will review the data with respect to the standard operating procedure and quality control methods
He will suggest correction and will ensure that the corrections are made prior to release of the material
Once raw data is audited, he will review the accompanying COA and will sign off the COA, if required
He will evaluate the results (perform 2 to 5) in SAP and then will give UD as required
They will collect and store the raw data (folders and lab notebook) and will submit to QA for archival
In case if there is Lab event, deviation or out of specification, the role will review all data generated as a part of investigation
The person will review the investigation report to ensure that there are no transcription errors in They report and will sign-off the report
The person will perform periodic audit trial review and will generate the report
The person will assist the department will upgrading / creating new SOPs as required
The person will assist the department by providing the requested data / document and by participation in any type of audit (internal and/or external)
Adhere to all safety and cGMP standards and guidelines, and report unsafe conditions, near misses, and/or injuries in a timely manner
Qualification
Required
A bachelor's degree with chemistry/pharmacy as major is required
Knowledge of handling HPLC and Empower chromatographic Software and minimum 3 years of experience in auditing of QC documents
Knowledge of other QC testing
Knowledge of current cGMP Guidelines as needed for effective function of role
Reviewing and Auditing Skills
Basic knowledge of working on computers
Knowledge of various pharmacopeia
Effective Communication (Written and Verbal)
Analytical and Problem solving ability
Document / Report drafting
All applicants must be legally authorized to work in the U.S. for any employer
Company
Avet Pharmaceuticals Inc.
Avet Pharmaceuticals Inc.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
George Svokos
President & CEO
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