Job Description
SHIFT - 7AM - 7PM ROTATE SCHEDULE EVERY 2 WEEKS 2 ON, 2 OFF, 3 ON, 2 OFF, 2 ON AND 3 OFF.
POSITION SUMMARY
The Manufacturing Associate I perform and documents cGMP activities to support upstream or downstream production areas and operations. This involves operation of process equipment, execution of validation protocols, completion of cGMP documents, creating/ revising cGMP documents and other assignments as directed.Shift work and/or weekend work may be required at times. KEY RESPONSIBILITIES
Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record.Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Key documentation includes batch records and equipment logbooks.Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices.Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMPsPerforms the weighing, dispensing of raw materials for media and buffersPerforms the preparation of small and large volume media and buffer solutions, filtration, and transfer of product.Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders, filter integrity testers etc.Dispensing, labeling, transfer/staging of raw materials and partsAssembly/disassembly, cleaning and sterilization of components, parts, and equipmentMaintaining equipment, area, and cleaning logbooksCleaning sanitizing production rooms and equipmentStocking production and cleaning suppliesMay author/ review/improve SOPs, batch records, protocols, and technical reportsActively participates in training activities, managing their individual training plan.Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area.Other duties as assignedPOSITION REQUIREMENTS:
High School Diploma with a minimum of 2-4 years GMP Manufacturing experienceOR
Certificate and/or associate degree in a scientific, engineering or biotechnology discipline with a minimum of 0-2 years related experience; coursework with biotechnology focus highly desirable,OR
Bachelors Degree (BS/BA) from an accredited college or university with an emphasis in ascientific or engineering disciplineand a minimum of 0-1 years relevant experienceBasic knowledge of current Good Manufacturing Practices (cGMPs). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.Familiar with or experience with cGMP Biotech or Pharmaceutical operations:Must be team-oriented (proactively builds healthy working relationships between peers, their department, and other groups).Able to fluently communicate in English. Exhibits excellent written and oral communication skills.Possesses a basic knowledge of non-manufacturing functions such as QC
