What are the responsibilities and job description for the QC Investigator position at Aurobindo Pharma USA, Inc.?
Division Overview
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
As a key site Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible for:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.,
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview
As a key site Quality Employee the QA Investigator will be responsible for assuring that the investigations are conducted and written in compliance with all cGMP regulatory as well as facility requirements. This individual will be responsible for:
- Leading, conducting, writing, reviewing and approving investigations for Deviations and Market Complaints.
- Assisting SMEs in root cause analysis and trending.
- Reviewing and approving CAPAs.
- Responsible for the investigation/CAPA SOPs as well as performing training to employees.
- Assist QA and Compliance as deemed necessary by the Head of QA.
- Deviation & Investigation Management
- Lead investigations for deviations, out-of-specification (OOS) results, and non-conformances.
- Use root cause analysis tools like 5 Whys, Fishbone diagrams, and FMEA to identify causes
- Document findings and ensure timely closure of investigations.
- Corrective and Preventive Actions (CAPA)
- Develop and implement CAPAs based on investigation outcomes.
- Track and trend deviations to identify recurring issues and systemic risks
- Analytical Testing Oversight
- Review analytical testing of APIs, drug substances, finished products, packaging materials, and stability samples
- Ensure testing is performed in compliance with cGMP, GLP, and data integrity standards.
- Documentation and SOP Management
- Author and revise SOPs related to investigations and quality control.
- Ensure documentation is complete, accurate, and compliant with regulatory standards
- Compliance and Audit Support
- Participate in internal audits and gap analyses.
- Support regulatory inspections by providing investigation reports and CAPA documentation
- Sample and Data Management
- Manage sample storage and ensure proper documentation of analytical results.
- Verify analytical reports for completeness and compliance
- Cross-Functional Collaboration
- Work closely with QA, QC, production, and regulatory teams to resolve quality issues.
- Provide training on investigation procedures and quality standards.
- Excellent technical writing skills, communication skills, organization skills.
- Must be able to speak, read, and write in English.
- For BS, up to 5 years in a regulated pharmaceutical industry preferably in QA.
- For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QA.
- Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and other regulatory requirements.
- Experience in conducting, writing non-conformance investigations, root cause analyses, and identifying corrective actions.
- Experience in CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review.
- Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits
- Dental Benefits with three dental plan options through CIGNA
- Vision Plan with two plan options through VSP
- Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
- Disability Insurance, Voluntary Short-Term Disability and State Disability
- Long-Term Disability (LTD), State (short term) disability - where applicable
- FSA (Flexible Spending Accounts) - Both Health Care & Dependent Care Available
- HSA (Health Savings Account)
- 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
- Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
- Critical Illness and Accidental Insurance
- Legal and Identity Theft Insurance
- Paid Time Off - Paid vacation, PTO, Holiday
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.
Physical Requirements
OFFICE POSITION - While performing the duties of this job the employee is required to:
- Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
- Specific vision abilities required by this job include close vision requirements due to computer work
- Light to moderate lifting is required
- Moderate noise (i.e. business office with computers, phone, and printers, light traffic).
- Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Physical Requirements
No Additional Requirements
Blood/Fluid Exposure Risk
Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.,
- Excellent technical writing skills, communication skills, organization skills.
- Must be able to speak, read, and write in English.
- Deviation & Investigation Management
- Lead investigations for deviations, out-of-specification (OOS) results, and non-conformances.
- Use root cause analysis tools like 5 Whys, Fishbone diagrams, and FMEA to identify causes
- Document findings and ensure timely closure of investigations.
- Corrective and Preventive Actions (CAPA)
- Develop and implement CAPAs based on investigation outcomes.
- Track and trend deviations to identify recurring issues and systemic risks
- Analytical Testing Oversight
- Review analytical testing of APIs, drug substances, finished products, packaging materials, and stability samples
- Ensure testing is performed in compliance with cGMP, GLP, and data integrity standards.
- Documentation and SOP Management
- Author and revise SOPs related to investigations and quality control.
- Ensure documentation is complete, accurate, and compliant with regulatory standards
- Compliance and Audit Support
- Participate in internal audits and gap analyses.
- Support regulatory inspections by providing investigation reports and CAPA documentation
- Sample and Data Management
- Manage sample storage and ensure proper documentation of analytical results.
- Verify analytical reports for completeness and compliance
- Cross-Functional Collaboration
- Work closely with QA, QC, production, and regulatory teams to resolve quality issues.
- Provide training on investigation procedures and quality standards.
Salary : $75,000 - $90,000