Careers in Quality - Tergus Pharma

Tergus Pharma is currently recruiting for a Quality Assurance Specialist & Manager Quality Control & Stability Operations.  These positions will contribute to Tergus Pharma's overall success by ensuring compliance with GMP/GLP regulations, Analytical, Stability Data and Data Review, documentation compliance, and internal lab procedures within a GMP/GLP analytical and manufacturing facility. 

QA Specialist Key Responsibilities:  

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• Review and approval of analytical documentation including methods, validation protocols, analytical data and reports (release, stability and validation).
• HPLC data review in Waters Empower 3
• Maintain and support completion of, including but not limited to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA, Complaints, Change Control, Equipment Qualification/Validation, Methods and Protocols
• Track and trend quality system metrics such as LIR/OOS, DEV, CAPA, Change Control and Customer Complaints.
• Perform CAPA review, approval and effectiveness checks.
• Support the vendor qualification program (documentation, audits, etc.).
• Perform facility and quality system audits.
• Quality Assurance review and approval of instrument/equipment calibration documentation, investigations, deviations, CAPAs and change controls.
• Quality Assurance review and approval of manufacturing documentation, including specifications and release, batch records, and batch release.
• Other duties as assigned

Manager Quality Controls & Stability Operations Key Responsibilities: 

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• Approval of QC analytical test methods, protocols and specifications;
• Management of the teams to ensure the workload is scheduled appropriately to meet customer Release testing schedules and stability pull dates and timelines.
• Ensure all data is reported through the appropriate channels of communication – Customer Certification of Analysis to external and
• stability databases internally.
• Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements
• Managing, Develop, and Maintain a diverse professional staff of Analytical Scientists and Data Reviewers with responsibilities for in- process, finished
• products, raw materials release, stability sample testing, analytical method development validation.
• Manage staff while promoting team collaboration and ensuring balance of workload and responsibility.