Manufacturing Upstream Specialist - Taiwan or Wuhan
Manufacturing Upstream Specialist
· Participate in the daily activities of the Cell Culture Manufacturing Group.
· Ensure operations strictly adhere to all QA-Controlled documents (such as SOPs, Batch Records) and cGMP/Quality requirements.
· Escalate process issues as necessary to ensure resolution.
· Ensure GMP training requirements are complete and current.
· Ensure all work is performed in a safe manner and meets the specifications for each service request.
· Apply proper PPE (Personal Protective Equipment) to all work in the facility.
· Clean and maintain the GMP facility and production equipment.
· Participate in the internal auditing program as required.
· Serve as a department representative on cross-functional teams.
· Review documentation and check all calculations (eg batch records, labels and equipment readings).
Job Qualifications (Education, Certifications, Experience)
· Bachelor’s Degree in Life Sciences.
· Good oral and written communication skills in English and Mandarin (Read, Write, Verbal).
· Basic knowledge and understanding of biopharmaceutical technology, processes, and the underlying scientific concepts.
· Must be flexible to work on any shift (day, night, weekend) and able to work prolong durations on your feet.
· Capable of writing detailed reports and summaries and exhibit detail oriented documentation skills.
· Communicate effectively and work professionally in a team environment.
· Skilled in the use of computers and automation-drive equipment.