As an integral part of the Large Scale Bulk Formulation team your main focus will be to manufacture PCR Reagents in large batch size utilizing Process Controlled Systems under a GMP Environment.
You are performing daily manufacturing activities and ensuring the quality of production is completed, including pre-manufacturing and post manufacturing duties, coordinating your activities with product demand and helping other team members.
You are contributing to a variety of duties relating to production operations, including Environmental Monitoring, Clean-In Place, completion of production batch records and logbooks using Good Documentation Practices (GDP).
You are responsible for following work production schedule, Standard Operating Procedures (SOPs), OSHA safety regulations and cGMPs to perform assigned production tasks.
You will be entering/updating required production data into trend lines and other work-output into appropriate business systems (e.g. SAP), and maintain documentation in accordance with established procedures.
You will be supporting and overseeing lab supply inventory, and generate internal order requisitions. Besides laboratory organization, you will also be handling hazardous materials in an ECA environment. Activities will require the use of pallet jacks, ability to lift 50lbs, and movement of pallets into the laboratory.
You will report with internal groups any room or equipment malfunction and may assist calibration to the area supervisor.
You will be completing required training classes in a timely manner to avoid compliance gaps.
Position Requirements:You hold a high school diploma.
You are characterized by a high level of social competence and are able to accurately record and efficiently communicate within a team while being known for your motivation as well as your independent, yet collaborative working style. Preferred:
Relevant experience with Human Machine Interface (HMI) and Process Controlled Systems (PCS) in a regulated environment.
You have 1+ years of experience with manufacturing in a regulated environment.