Description
This position will be responsible for participating in "Quality on the floor" activities in the manufacturing arena. Work closely with manufacturing personnel, provide quality support performing various checks during the manufacturing processes to ensuring all cGMP concerns and related matters are identified and resolved according to GMP, and regulatory requirements.***This is a second shift position (~1:00pm to 9:30 pm)***
* Role requires standing or actively watching manufacturing operations 4-6 hours / day.
* Work in tandem with manufacturing departments on the manufacturing floor to identify improvement opportunities, compliance concerns. Identify, prevent and resolve deviations.
* Monitor GMP practices in respective area and reports errors, deficiencies, discrepancies and observations to management in real time. May stop operations when product safety is or may be compromised. Approximately 75% of the typical workday spent in the respective manufacturing area.
* Assist with manufacturing related investigations within respective area, utilizing various tools for root cause analysis, failure mode analysis or risk assessment, as appropriate for the type of deviation being investigated. Assist in identifying corrective actions in order to prevent recurring events.
* Partner with Manufacturing and Quality Assurance colleagues to ensure thorough review of manufacturing and testing records, deviations and document changes.
* Track and trend compliance/quality issues; advise management of adverse trends or indicators of potential product/manufacturing issues requiring action.
* Maintain visual factory tool for metrics and deliverables as appropriate.
* Participate in Failure Mode and Effect Analysis (FMEA) and Operational Quality Risk Assessment processes.
* For continuous improvement, partner with manufacturing a and Quality Control in efforts to improve production processes and systems using Operational Excellence tools (such as 5S, Kaizen, Lean), assess area procedures and practices and optimize to improve efficiency where possible
Requirements
B.S./B.A. in Biological Sciences or a minimum 6 years of appropriate experience
* English fluency
* 6 years of related experience with a minimum of 4 years of GMP/ QSR/ISO and /or QA related experience.
* 2 - 3 years of pharmaceutical manufacturing or QA on the floor experience
* Certified in Six Sigma/ Lean preferred
* Experience in the following areas: fermentation, purification, Final Packaging and Quality Control
* Highly proficient in manufacturing investigations and root cause analysis
Please respond if interested to b.ross(@)realstaffing.com. Candidates considered local will be preferred. Thank you for your interest.
To find out more about Real please visit www.realstaffing.com