QC INVESTIGATOR

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.

• Lead and conduct investigations for:
• • OOS (Out of Specification) results
  • OOT (Out of Trend) results
  • Atypical/aberrant results
  • Laboratory incidents and deviations
• Follow a structured investigation approach as per site SOP.
• Writing the investigation Protocol and reports.
• Ensure timely closure of investigations within defined timelines.
• Define and recommend Corrective and Preventive Actions (CAPA).
• Track CAPA effectiveness and ensure timely closure.
• Responsible for closure of all QAMS documents on time 
• Responsible for maintain  GPL in laboratory
• Management of Standards / Column /Chemical in laboratory 
• Review analytical data, chromatograms, spectra, and raw data.
• Identify analytical errors, instrument failures, or method-related issues.
• Support method troubleshooting and improvement.
• Other responsibilities assigned by Director QC on routine basis

• Excellent technical writing skills, communication skills, organization skills.
• 3–8 years of experience in QC within pharmaceutical industry.
• Minimum 2–3 years in handling OOS/OOT investigations.
• MDI investigations experience preferred. 

• For BS, up to 5 years in a regulated pharmaceutical industry preferably in QC.
• For MS or higher degree, up to 3 years in a regulated pharmaceutical industry preferably in QC.
• 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

Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.