QA Associate I - QMS

Key Responsibilities The Associate - I is an entry level position critical for assisting in maintaining and implementation of Quality and Compliance standards and systems for Avet Pharma Labs Inc. Key responsibilities include assists in managing 3rd Party CMO Quality affairs to include CMO audits, Quality Agreements, Change Controls, Deviations, CAPA, maintaining quality metrics for periodic site reviews and will assist in FDA inspections as needed at Avet. This position entails strict adherence to company Standard Operating Procedures (SOPs), cGMP guidelines, and commitment to upholding environmental, health and safety standards. Reporting Relationships This position has no direct reports.This position typically works under direct supervision. Essential Functions and Detailed Duties The typical tasks/activities performed as QA Associate - I QMS in document control area are listed here but not limited to such as:Collect documents needed for Annual Product Quality Review (APQR) reports for all the products approved for Avet Pharmaceutical Labs Inc. that includes:Gather and Review Manufacturing Batch Records.Review of all the Raw and Packaging Material used for Manufacturing.Review Change Control Forms, CAPA, Stability Data, and the Deviations Report.Review Qualification and Validation status of Processes and Equipment, Complaints-Rework- Returned/Salvaged lots and Recalls and Field Alerts and OOS. Issuance of manufacturing and packaging batch records; process validation, cleaning validation and equipment qualification protocolsIssuance logbooks and miscellaneous documents to requesting departments as requestedArchive submitted documents like executed batch records, protocols, reports, chromatograms, QC data packets and any other submitted documents as per defined proceduresPerform Retain sample management and annual visual inspection as per procedureProvide documents to Regulatory and R&D department for filing purposes within assigned timelinesBasic understanding of stability study requirements and perform following tasks for maintaining stability program at Avet:Prepare stability protocols for products based on regulatory requirements Charge stability samples in the stability chamber and pull stability samples as per the approved stability schedulePrepare stability reports for Annual Product Review reports or Annual ReportsDisposition of stability samples upon completion of stability studyParticipate in QA activities related to handling Unplanned deviations, market complaints and change controlPerform initial QA evaluation in Trackwise as per approved proceduresCollect data and information for investigation as directed by supervisorPerform change assessment as per approved procedures and review associated documents for completeness and justification report for proposed changesCollecting data for monthly MRM, and Quarterly trend analysis reports Specialized Skills and Knowledge Basic understanding in GMP and importance of Document control in Pharmaceutical industryAble to communicate in English fluently and have moderate writing skillsKnowledge about various Oral Solid Dosage manufacturing activities (dispensing, blending, Granulation, compression, coating, Packaging etc.) and laboratory activitiesBasic knowledge of working on computers - MS Office. Education and Experience Bachelor's degree in life science, pharmaceutical science or chemistry fieldPrevious experience in pharmaceutical industry, preferred.Knowledge, experience and understanding of Quality systems within a solid dose manufacturing environment, a plus. Physical Demands/Factors: Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements. All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time. This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.