The Manufacturing Technician will perform a wide variety of manufacturing activities with applicable
internal procedures, current good manufacturing practices (cGMP), and pharmaceutical regulatory
requirements.
Key Responsibilities:
Performs manufacturing activities in cleanroom in accordance with cGMP.
Ensures personal training and qualification is up to date.
Completes documentation in accordance with good documentation practices (GDP).
Writes or revises standard operating procedures (SOPs) for the creation, development or improvement
of manufacturing activities as directed.
Assists during compliance inspections and audit readiness as required.
Maintains tracking logs for manufacturing product as assigned.
Performs materials management activities in accordance with cGMP.
Other essential duties as assigned.
Qualifications:
Strong technical skills and background knowledge in tissue culture.
Ability to strictly follow SOPs
Working knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Tissue Practices
(GTP), quality assurance systems, methods and procedures.
Consistency of good documentation practice
Ability to produce data reports with accuracy
Qualification to work in cleanroom environment
Attention to detail, critical thinking, and effective organizational skills required.
Ability to work collaboratively in a team environment.
Education and/or Experience:
Associate degree or equivalent or a certificate in biotechnology training program
A minimum of 0-2 years of experience within the pharmaceutical or biotechnology industry
Previous experience with quality systems and/or working in a regulated environment preferred