Job Description
Currently seeking a lab technician responsible for supporting manufacturing processes, operating various process equipment, and documenting daily manufacturing operations in a cGMP environment. The candidate will produce products by setting up, cleaning, and following aseptic procedures.
ResponsibilitiesParticipate in the aseptic processing of in-house made solutions as well as all patient processes according to cGMPs.Read, understand, and follow Standard Operating Procedures (SOPs).Set up and operate production equipment, such as control rate freezer and orbital shaker.Assist in deviation and CAPA investigations, compiling data/information related to internal investigations as required.Revise approved documents including SOPs, batch records, and MS forms as required.Perform routine transactions with the ERP system, including material requisitions and production tracking.Complete GMP documentation, including batch records, logbooks, and forms according to GDP guidelines.Maintain the clean room environment by following established procedures to keep it below alert level limits.Essential SkillsExperience in aseptic techniques.Familiarity with cGMP environments.Ability to read and follow SOPs.Experience operating lab equipment such as control rate freezer and orbital shaker.Experience in GMP documentation, including batch records and logbooks.Capability to perform routine ERP system transactions.Additional Skills & QualificationsAS/BS in a science field (life sciences preferred).2-5 years GMP experience (can be from industries outside of pharma) or BioWorks certification preferred.Cleanroom experience preferred.1-3 years of prior lab experience preferred.Experience following SOPs and executing batch records.Work Environment
The role will be based in both lab and office settings. The lab environment includes cleanrooms classified as level 10k and 100k, requiring sterile gowning and maintaining certification for sterile gowning. The position involves working in shifts: Shift 1: Sunday-Tuesday 7 AM-6 PM, Wednesday 7 AM-2 PM or Shift 2: Wednesday 11 AM-6 PM, Thursday-Saturday 7 AM-6 PM.
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