East Brunswick, NJ
- Job Level:
We are currently seeking a Compliance investigator to write as well as review investigations. This position is a direct hire in the pharmaceuticals industry in East Brunswick, NJ.
Our client is a success-driven pharmaceutical company that strives to maintain integrity and to offer the best product at an affordable rate.
- Responsible for handling, reporting, and documentation of Deviations, non-conformances, and complaints that are reported.
- Completes the investigations and closure of the incidents/CAPAs within the time frame.
- Assist in production supervision and perform other documentation work as required (change controls, SOPs, Protocols etc). Initiate deviations, complaints investigations as and when they are notified. As part of each investigation, gather information from all necessary internal and external sources in order to find the root cause and to evaluate the impact of the deviation on manufactured product, as well as the risk to previous products/future operations.
- The investigator will conduct and drive non conformance events/deviations to identify root cause, product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement.
- Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements.
- Work across functions with a professional manner to conduct investigations and works independently to comply with procedure driven guidelines relating to deviation investigations.
- Produce high-quality investigation documentation that meets applicable standards and is appropriate for its intended audience.
- Properly assess the manufacturing or analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
- Track the progress of the open CAPAs and ensure closure of the CAPAs in timely manner.
- Provides technical assistance to area supervisors or managers to solve complex problems.
- Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.
- Prepare monthly, quarterly and annual investigations/CAPAs trend reports.
- Discover and report any trends in reported deviations/investigations.
- Conduct training to employees based on the deviations/CAPAs. Initiate change controls for manufacturing related operations.
- Author departmental Standard Operating Procedures (SOPs), Protocols, technical reports etc.
- Assist in supervision of production operation.
- BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience.
Experience & Skills Required
- 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including Manufacturing, Validation and Process engineering.
- Pharmaceutical or related FDA work experience strongly preferred.
- Experience in solid dosage manufacturing, process, and quality.
- Demonstrates strong analytical and technical skills.
- Ability to articulate, discuss and glean information from Manufacturing, QC, QA, RA and engineering personnel to write a complete investigation.
- Excellent verbal communication and strong written English skills with a proven record of producing technical reports in a clear and concise manner.
- Strong experience and comprehension of MS Office programs — primarily MS Word and excel.
- Experience in statistical process control is a plus.
- Assures compliance with all procedures and policies concerning all areas of manufacturing, logistics, safety and human resources.
- Supervises manufacturing personnel in equipment setup and operation of critical production equipment and processes in accordance with cGMP’s, SOP’s, OJT’s, product batch records or other approved company documentation.
- Reviews product batch records for accuracy of entries, compliance to established limits, specifications and presence of all verification signatures.
- Plans and organizes the materials and machine time to meet daily, weekly and monthly production schedules for designated area of operation and communicates effectively to production operators and materials group to support.