What are the responsibilities and job description for the Operations Investigator - DPI position at Srimatrix Health?
ob Title: Operations Investigator - DPI
Location: Hauppauge, NY (Local Applicants Only)
Job Type: Full-Time | Onsite
Shift: 9:00 AM – 5:30 PM (Overtime as required)
Compensation: USD 21000 – 30000/ $21 – $30 per hour (based on experience)
Job Overview
We are seeking an experienced Operations Investigator to join a leading pharmaceutical manufacturing and packaging facility in Hauppauge, Long Island. The ideal candidate will have a background in chemistry or pharmaceutical sciences, hands-on experience in manufacturing or packaging operations, and a strong understanding of cGMP and FDA regulations. This position focuses on investigating deviations, identifying root causes, implementing corrective actions, and ensuring compliance with all quality standards.
Key Responsibilities
- Conduct investigations for manufacturing and packaging deviations and non-conformances to determine root cause and recommend CAPAs.
- Lead and collaborate with cross-functional teams to perform Root Cause Analysis (RCA).
- Prepare and present detailed investigation reports for medium to high severity non-conformances.
- Perform product impact analyses and ensure timely CAPA implementation.
- Review completed Batch Manufacturing Records (BMR) and logbooks in compliance with cGMP standards.
- Revise and maintain controlled documents such as SOPs, batch records, and logbooks.
- Monitor production processes to collect and analyze data for investigations and process improvement.
- Support product complaint investigations, OOS (Out of Specification) and OOT (Out of Trend) issues.
- Perform equipment qualification activities (IQ, OQ, PQ) and prepare required documentation.
- Conduct risk assessments and apply FMECA methodologies to identify and mitigate potential failures.
- Train new employees in investigative procedures and compliance standards.
Required Qualifications
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field.
- 2–5 years of experience in pharmaceutical manufacturing or packaging (pharma experience is mandatory).
- Solid understanding of current Good Manufacturing Practices (cGMP), FDA regulations, and SOP compliance.
- Proficiency with Microsoft Office, SAP, and TrackWise.
- Strong analytical, organizational, and communication skills.
- Ability to multitask and meet deadlines in a fast-paced environment.
- Fluent in written and verbal English.
Preferred Skills
- Experience leading or supporting regulatory audits.
- Familiarity with Failure Mode and Effects Analysis (FMEA/FMECA).
- Exposure to equipment qualification and validation in a GMP setting.
Compensation and Benefits
Benefits Include:
- Health Insurance (Medical, Dental, Vision)
- 401(k) with Company Match
- Health Savings Account (HSA) / Flexible Spending Account (FSA)
- Paid Time Off (Vacation, Sick, and Holidays)
- Short-Term and Long-Term Disability
- Parental and Family Leave
- Employee Discounts
Eligibility Requirements
- Must be authorized to work in the United States (U.S. Citizen or Green Card Holder only).
- Must have pharmaceutical manufacturing or packaging experience (no biopharma or unrelated industries).
Equal Opportunity Employer:
All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, or veteran status.
Job Type: Full-time
Pay: $21,000.00 - $30,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Flexible schedule
- Health insurance
- Paid time off
- Parental leave
- Vision insurance
Work Location: In person
Salary : $21,000 - $30,000